Medicine

Eli Lilly will give small biotechnology companies a chance to use artificial intelligence models trained on years of the pharmaceutical company’s research, launching Tuesday a new platform its says could help young startups a leg up in discovering new drug molecules. Called TuneLab, the platform incorporates data Lilly’s obtained developing “hundreds of thousands of unique…

Drug developers from around the world rang in a new era of sleep medicine Monday, as data from a series of clinical trials show narcolepsy can be effectively treated by amplifying a specific brain protein. That protein, called orexin-2, helps regulate important body functions like appetite, arousal and wakefulness, which has in turn made it…

Dive Brief: BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer who were enrolled in a Phase 2 trial, and stabilized disease in all of them, the company said Monday. Company executives said the study’s results at an interim data checkpoint confirmed the dose it has…

Artificial intelligence (AI) has quietly become a part of our daily lives – through personalized recommendations, virtual assistants, or smart devices, we barely notice it anymore. Yet many of us might not realize the advances AI is making in healthcare. From accelerating drug discovery to improving disease detection, it is transforming the way we understand…

Dive Brief: Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash it’s pulled in from venture capitalists this year to further its drug discovery. Its latest round was led by Premji Invest, the family office of Indian billionaire Azim Premji, and included backing from a mix of tech and…

Dive Brief: Sanofi shares dropped after the French drugmaker reported results from a highly anticipated study of a new kind of medicine for eczema that disappointed analysts and investors.  The experimental drug, amlitelimab, technically succeeded in the trial, meeting all of its primary and secondary endpoints when compared with a placebo in patients treated either…

Dive Brief: The Food and Drug Administration plans to work more closely and flexibly with developers of drugs for certain ultra-rare conditions, outlining Wednesday a new process to coordinate its assessment of such medicines across the agency’s two principal review offices.  The Center for Drug Evaluation and Research will work together with the Center for…

A newly launched startup is the latest young company to build itself around a drug discovered in Chinese laboratories. Hengrui Pharma on Friday said it licensed an experimental heart medicine to a secretive startup called Braveheart Bio. Per deal terms, Braveheart — a company incorporated in Delaware last year that doesn’t yet have a website…

Today, a brief rundown of news involving the Food and Drug Administration and Gilead Sciences, as well as updates from AC Immune, Agios Pharmaceuticals, Merck KGaA that you may have missed. Moving forward, the Food and Drug Administration plans to release the complete response letters it uses to reject drugmaker approval applications “promptly” after they’re…

Prolific biotechnology investment firm Atlas Venture said Thursday it raised $400 million to pump into its existing portfolio of drug startups, a move meant to support the companies that might struggle to secure further funding in the current climate.   The new fund is Atlas’ third “Opportunity Fund,” an investment vehicle that provides cash to the…

U.S. lawmakers clashed with Health and Human Services Secretary Robert F. Kennedy Jr. over his changes to the country’s vaccine policy and oversight of the Centers for Disease Control and Prevention, including the recent ouster of director Susan Monarez. Several members of the Senate Finance Committee called for Kennedy’s resignation at a hearing Thursday amid…

For the past four years or so, veteran drug hunters Josh Bilenker and Jeff Engelman have kept tightly under wraps the details of their latest project, a biotechnology startup called Treeline Biosciences. On Monday, they pulled back the curtain a little, unveiling the first compounds they have advanced into clinical testing for cancer. And they…

Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also the company’s first commercial product since it sold off its main revenue driver a few years ago. After some delays, the Food and Drug Administration…

Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars. The deal, announced Monday, revolves around a preclinical drug that Arrowhead designed to silence the genetic instructions for “alpha-synuclein,” a protein tied to Parkinson’s disease and other brain-eroding illnesses. Novartis has now agreed…

Today, we’re catching up after a long weekend on news involving Amgen and Replimune, as well as updates from Sanofi, Roche, Eisai and Biogen that you may have missed. Amgen on Tuesday said it will invest more than $600 million in a new center for science and innovation at its global headquarters in Thousand Oaks,…

The biotechnology careers of John Maraganore and Clive Meanwell have brought them into collaboration time and time again. As the respective founders of Alnylam Pharmaceuticals and The Medicines Company, the two previously partnered on the drug that would ultimately become Leqvio, which was later bought in a $10 billion acquisition of Medicines Co. by Novartis….

The case of Stealth BioTherapeutics and its rare disease drug could become a regulatory bellwether for other biotechnology companies seeking to understand how flexibly new leaders at the Food and Drug Administration will evaluate medicines for uncommon conditions. At the center of the ongoing back-and-forth is elamipretide, which Stealth is trying to get cleared for…

Dive Brief: Wugen said Wednesday that it brought in $115 million in a new financing round that will help the company advance an “off-the-shelf” CAR-T therapy. Fidelity Management & Research led the financing, which involved more than a half dozen other firms including RiverVest Venture Partners, Lightchain Capital, Abingworth and Tybourne Capital Management. Abingworth and…

Today, a brief rundown of news involving Amylyx Pharmaceuticals and Sanofi, as well as updates from Novartis, Roche and Eisai that you may have missed. A mid-stage clinical trial testing the best-known drug from Amylyx Pharmaceuticals has failed, leading the company to discontinue the experiment along with a related extension study. The drug, code-named AMX0035,…

Dive Brief: Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy. In the latest deal, Novo will provide research funding for Replicate Bioscience as well as up to $550 million in payments to work on new treatments for…

A federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. will meet in September to discuss and potentially vote on recommendations for vaccines against COVID-19, hepatitis B and measles.  According to a federal notice posted Thursday, the Advisory Committee on Immunization Practices will meet Sept. 18 and 19. A detailed…

Dive Brief: People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy alone, the company reported Wednesday. The summary results come from Lilly’s monarchE study, which began in 2017 and enrolled more than 5,600 adults with high-risk…

The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines that target a commonly circulating coronavirus strain, but narrowed who in the U.S. can receive them. In a post on the social media site X, Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA cleared shots from Pfizer, Moderna and Novavax…

Dive Brief: An RNA medicine developed by Regeneron Pharmaceuticals and Alnylam Pharmaceuticals helped control symptoms of the chronic autoimmune disease generalized myasthenia gravis in adults enrolled in a late-stage study, Regeneron said Tuesday. Regeneron also tested the RNA medicine, called cemdisiran, together with an antibody drug it developed and sells as Veopoz for another disease….

Dive Brief: Eli Lilly on Tuesday said it is ready to ask the Food and Drug Administration for approval of its GLP-1 pill orforglipron after the drug met the main weight loss goal in a Phase 3 trial in people with diabetes and obesity. In the trial, a high dose of orforglipron helped study participants…

The Food and Drug Administration has suspended the license of Valneva’s chikungunya vaccine following new reports of serious adverse reactions, sending shares in the French drugmaker sharply lower on Monday. In a statement Friday, the agency said its decision was based on concerns the shot “appears to be causing chikungunya-like illness in vaccine recipients.” More…

Dive Brief: Royalty Pharma has grabbed rights to a share in revenue from lung cancer drug Imdelltra, announcing Monday it will pay $885 million upfront for BeOne Medicine’s royalties paid by partner Amgen for sales outside China. BeOne, formerly known as BeiGene, has rights to Imdelltra revenue because of a $2.7 billion collaboration deal it…

A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices. DTC advertising has long been a target of Health and Human Services Secretary and MAHA leader…

Dive Brief: Rocket Pharmaceuticals plans to restart a Phase 2 gene therapy trial for a rare heart disease after working with the Food and Drug Administration to resolve questions around a study participant’s death earlier this year. The FDA ordered a hold on the research in May after the patient suffered from capillary leak syndrome,…

The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published by the White House Thursday. The statement provides additional clarity and detail surrounding the terms U.S. President Donald Trump and European Commission President Ursula von…

Dive Brief: Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027. The private agreements with debt holders will allow Sarepta to exchange the 1.25% convertible senior notes due in 2027 for $602 million worth of 4.875% convertible senior notes due in 2030, up to…

Today, a brief rundown of news involving Biohaven and Catalent, as well as updates from Stealth Biotherapeutics, Jazz Pharmaceuticals and Celldex Therapeutics that you may have missed. The Food and Drug Administration no longer plans to hold a meeting with outside experts to help evaluate an approval application for a Biohaven medicine called troriluzole. According…

Dive Brief: Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed to reprogram immune cells in patients’ bodies. If successful, Interius’ “in vivo” approach could yield a simpler alternative to the CAR-T therapies Gilead’s Kite Pharma…

The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine to reach market this year for the rare genetic condition. Donidalorsen, which Ionis will sell under the brand name Dawnzera, is approved to prevent the…

Eli Lilly is searching for a new neuroscience chief after announcing Wednesday that the division’s current head, Anne White, will retire in December after a 30-year career at the Indianapolis pharmaceutical company. White, who serves on Lilly’s executive committee, took over neuroscience leadership in 2021, when the company split its biomedicines unit in two to…

Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down. Xoma on Wednesday agreed to buy Mural Oncology, a cancer biotech once spun out of Alkermes. Per deal terms, a Xoma subsidiary will acquire Mural for $2.035 per share. Mural…

Dive Brief: Australian drugmaker CSL is separating its vaccine business, Seqirus, into a standalone company as part of a sweeping restructuring across its business that will involve workforce cuts of up to 15%. CSL said Tuesday that a separated Seqirus, which will be chaired by former unit president Gordon Naylor, “will allow autonomy to set…

Dive Brief: An experimental weight loss pill from Viking Therapeutics helped people with obesity lose up to 12% of their body weight over 13 weeks in a Phase 2 trial, beating a placebo by 11 percentage points, the company said Tuesday. The pill, called VK2735, also helped a higher proportion of study volunteers lose at…

To many scientists and doctors, messenger RNA vaccines are an incredible feat of modern medicine. But to top health leaders in the Trump administration, shots made with the technology pose more risks than they do benefits. Earlier this month, Secretary Robert F. Kennedy Jr. directed the Department of Health and Human Services to cancel some…

Dive Brief: Stealth BioTherapeutics is once again seeking U.S. approval of a drug for the rare condition Barth syndrome, claiming in an announcement Monday that it has addressed concerns that led the Food and Drug Administration to reject the therapy in May. Stealth said it provided the FDA with information the agency requested on safety…

Over the next five years, several blockbuster oncology drugs from leading pharmaceutical companies will lose patent protection, ushering in a wave of “patent cliffs” that pose significant revenue and strategic risks. This concentrated wave of oncology losses of exclusivity (LOEs) stems from a historic surge in immuno-oncology approvals during the mid-2010s, particularly in checkpoint inhibitors…

The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in the U.S., launching a new program dubbed PreCheck that aims to ease the process of bringing domestic facilities online. Using a two-phase approach, the program offers drug companies more frequent communication with the agency in early stages and streamlines development through…

Vedanta Biosciences, a startup working on microbiome drug research for more than a decade, will lay off nearly a fifth of its staff after one of its top prospects failed a clinical trial.  The privately held company said Wednesday that an experimental therapy called VE202 missed its main goal in a Phase 2 study in…

Merck KGaA has been making moves to propel itself into becoming what CEO Belén Garijo described as a “globally diversified science and technology powerhouse.” Most recently, the company closed a $3.4 billion acquisition of Pfizer spinout SpringWorks Therapeutics, which will help it stake a claim in the rare oncology market. More broadly, Merck KGaA’s strategy…

Today, a brief rundown of news involving Precigen and Pfizer, as well as updates from the Institute for Clinical and Economic Review, Superluminal Medicines and Generation Bio that you may have missed. The Food and Drug Administration granted full approval to a first-of-its-kind treatment for recurrent respiratory papillomatosis, a rare and potentially life-threatening condition caused…

The Department of Health and Human Services announced Thursday it will reinstate a disbanded task force on childhood immunizations, claiming that it will work to improve the “safety, quality, and oversight of vaccines administered to American children.” The Task Force on Safer Childhood Vaccines will work with the Advisory Commission on Childhood Vaccines, and make…

Dive Brief: Sarepta on Wednesday announced the divestment of its entire equity stake in partner Arrowhead Pharmaceuticals as the company faces the need to make milestone payments of as much as $300 million in coming months. Arrowhead agreed to take 2,660,989 shares back to satisfy half of a $100 million milestone payment due to the…

Eli Lilly on Thursday responded to a Trump administration plan to lower U.S. drug costs by issuing a statement claiming it will raise prices in European countries to “align” them with the costs paid “across developed countries.” The statement, which wasn’t attributed to any specific Lilly executive, said the effort includes an agreement with the…

Dive Brief: Vor Biopharma on Wednesday said a late-stage study run in China by its partner RemeGen succeeded, showing that treatment with an experimental drug called telitacicept helped reduce disease activity in people with the autoimmune condition Sjögren’s syndrome. Vor didn’t share any specifics, but noted RemeGen plans to ask China’s health regulator for approval…

AbbVie plans to spend $195 million to build a new facility to produce active pharmaceutical ingredients in its hometown of North Chicago, Illinois. Construction will begin in the fall, and the site should be fully operational in 2027, AbbVie said Tuesday. The facility will help the company produce both current and future medicines in neuroscience,…

Dive Brief: PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new company that will develop a respiratory disease treatment it’s been advancing through clinical testing. Called Celea Therapeutics, the company debuts with a drug candidate nearing late-stage trials that the company believes could treat multiple inflammatory…

Dive Brief: Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated airways in the lungs, chronic cough and frequent respiratory infections. Brinsupri is the first drug to treat bronchiectasis not caused by cystic fibrosis and the…

An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits on Monday.  IO Biotech, however, still believes the vaccine performed well enough to warrant a potential approval consideration from U.S. regulators. The company noted how…

Strand Therapeutics has raised a $153 million Series B round fresh off unveiling early, but promising results for a cancer therapy it’s making with messenger RNA technology.  The biotechnology startup plans to use the funding to advance that therapy, STX-001, into further testing. A second, experimental medicine called STX-003 should start a Phase 1 clinical…

Novo Nordisk is battling back against the threats to its obesity drug business, saying in an earnings report Wednesday that it expects a significant boost from a major insurer deal and wider legal actions against the companies making knockoff versions of Wegovy.  Competition from Eli Lilly’s rival weight loss drug Zepbound as well as the…

The Department of Health and Human Services is canceling nearly $500 million in contracts for the development of messenger RNA vaccines in a controversial pivot away from a technology that delivered safe and effective COVID-19 shots in record time during the pandemic. According to a Tuesday statement from HHS, the Biomedical Advanced Research and Development…

Lawmakers in Washington share U.S. drugmakers’ angst about being surpassed by China’s fast-progressing biotechnology sector, but aren’t raising alarms over the recent surge in licensing deals for medicines discovered there, according to Pfizer CEO Albert Bourla. On an earnings conference call Tuesday, Bourla described concern around China’s “emerging superiority” in several areas, including biotech, as…

Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost, Pfizer CEO Albert Bourla said Tuesday. “We have serious discussions in the industry,” Bourla told investors on a conference call Pfizer held to discuss its…

The Gates Foundation on Monday said it is committing to invest $2.5 billion over the next five years to accelerate research and development in neglected areas of women’s health. The funding will be channeled toward five priority areas of research that are particularly research to low- and middle-income countries. Among the targets for investment are…

A brain-focused biotechnology company saw a double-digit stock drop Monday morning even as it unveiled clinical trial results that some on Wall Street considered top notch. The mid-stage study recruited adults with either of two epileptic disorders, and gave them all a drug from Praxis Precision Medicines once a day for about two months. According…

Moderna said Thursday it plans to lay off 10% of its workforce, or more than 800 employees, as part of an ongoing effort to cut expenses amid slowing vaccine sales. Moderna first announced last September a plan to lower $1.5 billion in annual operating expenses by 2027, largely by trimming research spending. The company planned…

Frazier Life Sciences on Thursday said it has closed a new venture capital fund for startup creation and investing in early-stage biotechnology companies, raising $1.3 billion. Frazier is the third life sciences investor to announce fresh funding in the last two months, following Omega Funds’ $647 million raise and Deerfield Management’s $600 million fund. “We…

Biotechnology companies specializing in psychedelics research saw their share prices rise after rumors of a billion-dollar acquisition hinted that big pharma is now more open to betting on this area of drug development. Bloomberg News reported early Thursday that AbbVie is in talks to buy privately held Gilgamesh Pharmaceuticals. If agreed to, the deal would…

The 17 vaccine advisers fired by Robert F. Kennedy Jr. last month called Wednesday for an alternative to the panel from which they were ousted, arguing that the federal government has “upended the U.S. vaccine policymaking process.” The former members of the Advisory Committee on Immunization Practices, which provides vaccine recommendations to the Centers for…

The U.S. plans to lift its pause on country-specific tariffs while implementing a range of new rates for specific trading partners on Aug. 7, per an executive order President Donald Trump signed Thursday.  The order lists rates for over 60 trading partners, ranging from 10% to 41%. The list includes levies for countries that match…

Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenx that you may have missed. Regeneron said two more of its new drugs hit regulatory setbacks because of Food and Drug Administration inspection issues at a third-party manufacturing plant. The company received a complete…

President Donald Trump on Thursday threatened 17 large drugmakers with “every tool in [the federal government’s] arsenal” if they don’t take steps to lower the prices of their products in line with those charged in other industrialized nations. Letters sent to the companies followed up an executive order Trump issued May 12 that seeks to…

Dive Brief: Sales of an Alnylam Pharmaceuticals rare disease medicine substantially outpaced Wall Street expectations in the drug’s first full quarter since U.S. regulators expanded its use, lifting the biotechnology company’s market value to new highs on Thursday. According to Alnylam, sales of the drug, called Amvuttra and sold for two types of transthyretin amyloidosis,…

Vinay Prasad’s sudden resignation from the Food and Drug Administration Tuesday once again leaves the biopharmaceutical industry, which has spent much of the year in turmoil, wondering what to expect from its principal regulator. Prasad’s brief stint as director of the Centers for Biologics Evaluation and Research and apparent right-hand man to Commissioner Martin Makary…

Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well as updates from Apellis Pharmaceuticals, PTC Therapeutics and Arrowhead Pharmaceuticals that you may have missed. Seeking to expand treatment of the liver disease MASH, Madrigal Pharmaceuticals is paying $120 million to Hong Kong-based drugmaker CSPC Pharmaceutical Group for global rights to…

Vinay Prasad, the controversial head of the Food and Drug Administration office that oversees vaccines and gene therapy, has abruptly left the agency after less than three months on the job. Andrew Nixon, a spokesperson for the Department of Health and Human Services, confirmed Prasad’s departure in an emailed statement Tuesday. “Dr. Prasad did not…

Dive Brief: Merck & Co. is launching a new cost-cutting program, announcing Tuesday a plan to redirect by the end of 2027 $3 billion away from older, slow-growth businesses to newly launched drugs and experimental medicines it hopes can drive faster revenue growth. The move comes as Merck prepares for generic competition to its cancer…

The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one week after demanding the company halt sales over safety concerns. In a statement Monday evening, Sarepta said it would begin shipments to treatment sites “imminently.”…

Biotechnology firm Celcuity said Monday a late-stage trial testing its experimental breast cancer therapy in combination with other drugs succeeded, positioning the Minneapolis-based company to submit an approval application to the Food and Drug Administration later this year. Treatment involving the biotech’s drug, called gedatolisib, significantly reduced the risk of disease progression or death in patients…

An experimental drug from AstraZeneca succeeded in a late-stage trial in an autoimmune condition called generalized myasthenia gravis, positioning the company to grow a business it inherited when acquiring Alexion Pharmaceuticals five years ago. The drug, known as gefurulimab, met its main and secondary objectives in a Phase 3 study involving 260 people with the…

Today, a brief rundown of news involving Rocket Pharmaceuticals and Atara Biotherapeutics, as well as updates from Abivax, Gate Bioscience and Matchpoint Therapeutics that you may have missed. Rocket Pharmaceuticals is laying off approximately 30% of its workforce and focusing resources on gene therapies for three inherited heart conditions, the company said Thursday. Rocket expects…

European drug regulators on Friday recommended rejecting Sarepta Therapeutics’ Elevidys in the latest setback for the struggling biotechnology company and its embattled gene therapy for Duchenne muscular dystrophy. The European Medicines Agency issued a negative opinion on an application submitted by Roche, which owns Elevidys rights outside of the U.S., for clearance in Duchenne patients…

A key committee that helps decide what new medicines enter the European market has changed its mind about a closely watched drug for Alzheimer’s disease, and is now putting its support behind the therapy. The reversal is a win for Eli Lilly, which developed the drug and has already secured marketing approvals in Japan, China,…

The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application. In a Friday statement, Bayer said the FDA did not raise any concerns around “general approvability” of the drug, called elinzanetant. Still, the agency extended…

AstraZeneca executive Cristian Massacesi will join Bristol Myers Squibb as its chief medical officer, replacing outgoing executive Samit Hirawat, the company said Friday. Massacesi, who served as chief medical officer at AstraZeneca the past four years, will start Aug. 1. His predecessor, Hirawat, is leaving to “pursue new professional opportunities,” according to an announcement. Since…

Dive Brief: Galapagos on Wednesday said it’s considering selling its cell therapy business, which previously had been the centerpiece of a restructuring plan.  In January, the Belgian drugmaker said it would split into two pieces, one that would keep the name Galapagos and focus on cell therapy and another that would build a pipeline by…

TCG Labs Soleil, a venture firm building narrowly focused biotechnology startups and readying them for partnerships, said Thursday it raised $400 million to continue launching new companies. The firm originally launched last year in collaboration with The Column Group, raising $400 million to begin its work. It operates through a venture fund, TCG Labs, and…

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday endorsed a federal advisory committee’s recommendation to remove a contested preservative from the few influenza vaccines that currently contain it. Advisers to the Centers for Disease Control and Prevention who Kennedy hand-picked earlier this year voted last month to remove thimerosal from flu shots,…

Dive Brief: Roche is pausing sales of the Duchenne gene therapy Elevidys in some countries outside the U.S. after partner Sarepta Therapeutics agreed Monday to a Food and Drug Administration request to do the same in the U.S. Roche said Wednesday it is temporarily and voluntarily halting shipments of the treatment in countries that reference…

Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. The Food and Drug Administration on Tuesday rejected a melanoma drug developed by Replimune. According to the Massachusetts-based biotechnology company, the agency said in a complete…

Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private biotechnology company Vicebio and its portfolio of experimental vaccines. Through the deal, Sanofi will gain a combination shot now in clinical testing for protection against respiratory syncytial virus and human metapneumovirus, or hMPV. Vicebio specializes…

WASHINGTON — AstraZeneca, the U.K.’s third biggest company by market value, is making itself a bit more American. On Monday, AstraZeneca CEO Pascal Soriot joined Virginia Governor Glenn Youngkin in Washington D.C. to sign an agreement on the company’s plans to spend $4 billion building a new drug factory in the state. The investment is…

One month ago, a 51-year-old man treated in a clinical trial with an experimental gene therapy became dangerously sick. The developer of that treatment, Sarepta Therapeutics, informed the Food and Drug Administration his case could be life-threatening.  The man died from acute liver failure a few weeks later, which Sarepta reported to the FDA on…

Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical company’s portfolio during a year in which its formerly top-selling drug lost market exclusivity. Second quarter sales for J&J’s pharmaceuticals business reached $15.2 billion between April and June, nearly 4% higher…

Bristol Myers Squibb and Pfizer will begin offering their top-selling heart medicine Eliquis through a new online service at a discounted price — the latest example of pharmaceutical companies establishing direct-to-consumer options to bypass traditional drug distribution channels.  The two companies, which sell the blood-thinning drug through a longstanding joint venture, said Thursday that they’ll offer…

Another person treated with a Sarepta Therapeutics gene therapy has died, compounding concerns about the safety of the company’s genetic treatments. Sarepta on Friday confirmed the death of a 51-year-old patient with limb-girdle muscular dystrophy who died after treatment with the company’s experimental SRP-9004 therapy in a Phase 1 study. Earlier this year, Sarepta reported…

Today, a brief rundown of news involving Bristol Myers Squibb and the Food and Drug Administration, as well as updates from DiaMedica Therapeutics, GSK and PureTech Health that you may have missed. An anemia treatment from Bristol Myers Squibb failed to meet its primary goal in a Phase 3 study of people with low blood…

A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration. Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic…

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with…

Dive Brief: New data from HSBC Innovation Banking add further evidence venture capital funding for private biotechnology companies has slid lower as the year has progressed, erasing what was a fast start to 2025. According to a report HSBC published Thursday, “first financings” for biotech startups fell from a total of $2.6 billion in the…

Novartis is exploring options to meet the Trump administration’s goal of bringing U.S. drug prices down to match what European and other high-income countries pay, but doesn’t expect any policy resolution soon, CEO Vas Narasimhan said on an earnings call Thursday. “Conversations with the administration, from the Novartis standpoint, have been productive, very open dialogue…

Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that follows a series of setbacks and the collapse of the company’s share price this year. In a statement Monday, Sarepta said it plans to cut approximately 36% of its staff and pause research on several drug programs. The company expects the…

An experimental rare disease drug from AstraZeneca failed in two late-stage trials, though the company said Wednesday there were signs of a survival benefit in a prespecified subgroup of patients. AstraZeneca has been developing the drug, anselamimab, for people with late-stage light chain amyloidosis, a disorder in which proteins made by plasma cells misfold and…

Dive Brief: An experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera Therapeutics succeeded in a Phase 3 trial in China, positioning the companies to seek approval there and to begin global late-stage testing. The drug, a once-weekly injection dubbed HRS9531, spurred about 18% weight loss in treated participants after 48 weeks, roughly…

Dive Brief: LaNova Medicines, a cancer drugmaker that previously licensed medicines to Merck & Co. and AstraZeneca, has agreed to be acquired by Sino BioPharmaceutical in a deal worth up to $950.9 million. In an agreement disclosed Tuesday, Sino BioPharm will buy the approximately 95% of LaNova it doesn’t already own. Accounting for LaNova’s cash…

A group of private equity firms are pouring funding into PCI Pharma Services, betting the contract drug development and manufacturing organization’s business is poised to grow in the years ahead. PCI said Monday that Bain Capital and existing lead private equity backer Kolberg have made an unspecified investment in the company. That funding was supported…

Dive Brief: An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study of people with either uncontrolled or treatment-resistant hypertension, the pharmaceutical firm said Monday. The reduction in mean seated systolic blood pressure associated with AstraZeneca’s drug was clinically meaningful, the company added. Called baxdrostat, the drug…

The drug industry’s efforts to develop a treatment for a rare kidney condition known in shorthand as ADPKD have come in fits and starts. People with ADPKD, or autosomal dominant polycystic kidney disease, can use an Otsuka drug, Jynarque, that U.S. regulators cleared in 2018 to slow the decline in organ function that’s brought on…

Dive Brief: AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to an early-stage experimental trispecific antibody that has shown promise in multiple myeloma. Under the terms of the deal announced Thursday, AbbVie will gain rights to ISB 2001 in North America, Europe, Japan and China. Ichnos Glenmark will be eligible for as…

The Food and Drug Administration on Thursday published more than 200 drug rejection letters in a notable policy shift it said will pull back the curtain on feedback the agency gives to biotechnology and pharmaceutical companies. The FDA has not historically made public the details of its rejection decisions, citing the confidential trade secrets such…

The Food and Drug Administration has rejected what was set to be the first treatment for heart-related complications of Duchenne muscular dystrophy, indicating that its developer, Capricor Therapeutics, didn’t prove the treatment’s effectiveness in clinical testing. Capricor on Friday said the agency turned back the drug, deramiocel, because the company’s application didn’t meet the FDA…

Merck & Co.’s $10 billion acquisition of Verona Pharma Wednesday is a dramatic outcome for a company that’s spent 20 years developing a respiratory drug it now sells as Ohtuvayre. The treatment has been in testing so long its principal patent expired before former President Joe Biden took office. If Merck and Wall Street’s forecasts…

Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as updates from Ultragenyx Pharmaceutical, Nuclidium and Pharvaris that you may have missed. The European Medicines Agency on Friday lifted its order to pause use of Valneva’s chikungunya vaccine in people aged 65 years and older. The decision to remove the restriction…

Dive Brief: The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease. The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated…

The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. According to Soleno Therapeutics, net revenue from sales of the medicine, known as Vykat XR, are expected to total between $31 million and $33 million for the…

Merck & Co. has agreed to pay $10 billion to buy London-based Verona Pharma, scooping up a potential multibillion-dollar new drug to treat chronic obstructive pulmonary disease in a deal announced Wednesday. The Food and Drug Administration approved Verona’s Ohtuvayre in June 2024 for maintenance treatment of COPD in adults. It’s the first inhaled treatment…

Dive Brief: The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling, the company said Tuesday. That side effect, called ARIA, has made physicians reluctant to prescribe…

President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday. Trump indicated official announcements of the tariffs would come “very soon” but did not elaborate on an exact timeline. He did say,…

Dive Brief: Novartis won regulatory approval Tuesday of the first malaria medicine for newborns and the youngest infants, who until now had no treatment specifically available for them. Regulators in Switzerland cleared the pharmaceutical company’s Coartem Baby, which is a new formulation of a two-drug regimen that for years has been used against malaria in…

Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations. Fiiled Monday, the lawsuit argues that Kennedy’s directive, which removed guidelines recommending COVID vaccination for pregnant people and healthy children, is unlawful and “a pressing…

Dive Brief: After a delay due to “resource constraints,” the Food and Drug Administration on Monday approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare disorder hereditary angioedema. Ekterly is the first oral drug to treat hereditary angioedema, or HAE, attacks, competing with shots like Firazyr from Takeda and Ruconest…

Dive Brief: Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, the companies announced Monday.  The acquisition will hand AbbVie access to technology developed by Capstan that uses small fatty spheres known as lipid nanoparticles to deliver into the body genetic instructions able to engineer specific…

Acadia Pharmaceuticals, the brain-focused drug developer, surprised some on Wall Street last week with a pair of predictions. The first: the company’s two products, which brought in close to $1 billion in 2024, should eventually generate between $1.5 billion and $2 billion in combined yearly sales. The second: five experimental medicines in Acadia’s research pipeline…

Dive Brief: Organon’s experimental treatment for endometriosis failed to improve pelvic pain for women in a Phase 2 study, leading the company to give up on the drug. The trial tested three oral doses of OG-6219 in women between the ages of 18 and 49 who have moderate-to-severe pain related to endometriosis. Researchers had hoped…

Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital, as well as updates from Roche, Hikma Pharmaceuticals and several others that you may have missed. The Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals bispecific antibody linvoseltamab for relapsed or refractory multiple myeloma. The clearance was based on tumor…

In the notoriously expensive business of drug development, SiteOne Therapeutics made do with little. The biotechnology startup formed in 2010, aiming to create new, non-addictive pain relievers at a time when overdoses involving opioids were killing more than 20,000 people in the U.S. each year. Yet the dire need for safer medications didn’t resonate with…

Dive Brief: Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant depression in a Phase 2b study. Shares of Atai jumped 20% after the companies’ announcement Tuesday. Atai also announced a $50 million private placement in…

Dive Brief: Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of being acquired by Supernus Pharmaceuticals, according to a Massachusetts regulatory filing. The move comes less than two weeks after Supernus announced it would buy the developer of the postpartum depression drug Zurzuvae for $561 million,…

Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of influenza-like illness in people 50 years and older by 27% compared with those given a marketed shot targeting three or four strains of the virus, the company said Monday. The COVID-19 vaccine pioneer said it will…

Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who led the cancer and blood disease drugmaker for the past 11 years. Meury, whose appointment is effective immediately, previously ran Anthos Therapeutics, which he sold this year to Novartis for nearly $1 billion, and Karuna…

Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday, a little over one month after announcing plans to review strategic alternatives. As part of its shift in focus, Vor also announced it appointed former MorphoSys leader Jean-Paul Kress as CEO. Vor’s previous chief executive…

Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy benefit managers’ chokehold on the U.S. drug market, experts said during a drug pricing transparency forum in Washington, D.C. this week. Influential lawmakers on both…

The Supreme Court on Friday upheld a popular provision of the Affordable Care Act that requires private insurers cover a range of preventive healthcare services without cost sharing. The 6-3 ruling is a victory for public health advocates and providers, who say the mandate preserves Americans’ access to critical care, including cancer screenings, tests for chronic…

Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. Biocryst said Friday it is selling the European business of its hereditary angioedema drug Orladeyo to Italy’s Neopharmed Gentili for $250 million upfront. The deal, which transfers BioCryst’s European sales organization to…

Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies, removing several onerous requirements as well as loosening restrictions on which facilities can provide treatment. The FDA’s action applies to therapies made by Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson and Novartis that are…

Dive Brief: Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming flu season be free of the preservative thimerosal, addressing unproven fears the mercury-containing substance can lead to developmental disabilities. If confirmed by the CDC, the recommendation from the Advisory Committee on Immunizaiton Practices, or ACIP,…

Acadia Pharmaceuticals has proposed that its pipeline of experimental medicines could, if eventually brought to market, peak at $12 billion in annual sales. The brain drug developer disclosed this estimate Thursday, during its first major research and development event. The company expects eight programs to be in human testing this year, and to have data…

Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time Wednesday since the Health and Human Services secretary abruptly fired their predecessors earlier this month. While the advisers didn’t vote on any new recommendations, they probed aggressively into the evidence underpinning use of vaccines for COVID-19 and signaled plans…

Dive Brief: Kymera Therapeutics and Gilead Sciences will develop oral molecular glue degraders under a deal announced Wednesday, which could hand the former as much as $85 million in upfront and option exercise fees. The biotech also said Wednesday that existing partner Sanofi will advance a different protein degrader candidate called KT-485 into clinical testing…

Today, a brief rundown of news involving Sarepta Therapeutics, Capricor Therapeutics and Nektar Therapeutics, as well as updates from AstraZeneca, Revolution Medicines and Carisma Therapeutics that you may have missed. The Food and Drug Administration is investigating two deaths among patients treated with Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy. Both patients died…

Senator Bill Cassidy, a powerful Republican senator from Louisiana, has called for an important federal vaccine meeting this week to be delayed, after Health and Human Services Secretary Robert F. Kennedy Jr. fired and replaced the panel’s prior members. In a post to the social media site X Monday evening, Cassidy said the meeting should…

On the heels of the BIO International Convention and as I reflect on the passion for innovation that drives this industry, one truth I keep coming back to is this: there is the potential for failure in drug development, but we cannot let that deter us. Developing therapies is a grueling, difficult process, one that…

Dive Brief: Shares of San Diego biotechnology company Cidara Therapeutics doubled Monday after the company revealed positive mid-stage study results for an experimental preventive therapy it’s developing for seasonal influenza. The drug, an antiviral that combines a small molecule with a protein fragment, met its main and secondary goals in a Phase 2b trial. A…

Dive Brief: Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to support drug research it’s initially aiming at rare genetic diseases, but sees having broader potential, too. Actio’s most advanced program is in early-stage testing for the degenerative nerve disorder Charcot-Marie-Tooth disease, but may also be…

Dive Brief: Two senior officials at the Food and Drug Administration office that regulates gene therapies have reportedly been placed on administrative leave, resurfacing questions about the way the complex medicines will be regulated under new agency leadership. Nicole Verdun, a director of the Office of Therapeutic Products at the Center for Biologics Evaluation and…

Biotechnology industry watchers were hopeful at the start of 2025. Venture funding appeared to be rebounding after a lengthy slump, and a smattering of new stock offerings and company acquisitions brewed optimism that the public markets might be similarly warming up to young drugmakers. But the positivity quickly dissipated. Trump administration policies gutted scientific research…

Today, a brief rundown of news involving Prothena and Zealand Pharma, as well as updates from Biogen and Sanofi that you may have missed. Prothena is laying off 63% of its workforce to focus resources on its remaining wholly owned and partnered drug programs, the company said Wednesday. The company and its financial advisors are…

Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the agency’s powers to speed up drug reviews, announcing on Tuesday a plan to evaluate new medicines that address U.S. “national interests,” like a health crisis, in just one to two months.  The initiative builds on the “priority review” program in place since…

Psychiatric medicine remains one of the more challenging and risky areas of drug research. Many prospects show initial promise only to fail later on. Still, recent breakthroughs are spurring more investments and acquisitions in biotechnology companies working on new brain drugs. A startup debuting with a nine-figure bankroll is the latest evidence.  That startup, Draig…

The Food and Drug Administration has approved a new way to prevent HIV, clearing a Gilead Sciences drug that requires only two injections a year to protect against infections.  The treatment, known scientifically as lenacapavir and to be sold as Yeztugo, was approved on Wednesday to reduce the risk of sexually acquired HIV infections in…

Dive Brief: A medicine developed to treat a genetic muscle-wasting disease can improve results for patients taking GLP-1 weight-loss medicines, according to a new Phase 2 study. Scholar Rock has already applied for Food and Drug Administration approval of the drug, dubbed apitegromab, for patients with spinal muscular atrophy based on a Phase 3 trial…

Today, a brief rundown of news involving CSL and Intellia Therapeutics, as well as updates from Eli Lilly and 23andme that you may have missed. The Food and Drug Administration on Tuesday approved CSL’s Andembry, an antibody drug known scientifically as garadacimab, for hereditary angioedema. Andembry is a first-of-its-kind, once-monthly injection that prevents the swelling attacks associated with…

Dive Brief: Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease.  The deal announced Tuesday offers Verve stockholders $10.50 a share, plus a contingent value right worth another $3 a share. The non-tradeable CVR would pay out if the company’s experimental VERVE-102…

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from the agency, industry groups were relieved that the plan they sued to stop was dead. The U.S. District Court for the Eastern District…

Dive Brief: Sage Therapeutics, a brain drug developer that’s dealt with a series of clinical setbacks, has agreed to be acquired by Supernus Pharmaceuticals in a deal worth $561 million.  Supernus on Monday said it would pay $8.50 per share for Sage, an offer valuing shares at a roughly 27% premium to their previous closing…

Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people whose metastatic non-small cell lung cancer has a type of alteration in the gene ROS1. Ibtrozi was approved based on a pair of trials showing response rates…

Today, a brief rundown of news involving Insmed and Recursion Pharmaceuticals, as well as updates from Odyssey Therapeutics, Gilead Sciences and Novo Nordisk that you may have missed. Insmed said Tuesday its experimental drug for pulmonary arterial hypertension succeeded in a Phase 2 trial , significantly improving blood flow in the lungs of study volunteers…

The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. The legislation, which was narrowly approved in the House last month and is now in the hands…

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Today, a brief rundown of news involving AstraZeneca and Third Harmonic Bio, as well as updates from UCB, UroGen Pharma and Insmed that you may have missed. AstraZeneca on Friday formed a new collaboration with Shijiazhuang City, China-based…

The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a company that’s been negatively impacted by the recent leadership changes atop U.S. public health agencies.   The shot, dubbed mResvia, was cleared on Thursday for adults aged 18 to 59 who are at high risk for…

Dive Brief: Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging weight-loss medicine to the list of prospects it has in advanced testing. The Danish drugmaker said Thursday the trials could begin in early 2026, and will test both an injectable and an oral formulation. In…

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday continued his efforts to alter the government structure supporting immunizations, naming vaccine skeptics and doctors with different focus areas to a critical advisory board days after purging the old one. Kennedy shocked public health advocates and the vaccine industry on Monday by firing the…

Dive Brief: COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially billions of dollars worth of royalties related to intellectual property on messenger RNA drugs. Per deal terms, each CureVac share will be exchanged for about…

Dive Brief: Bristol Myers agreed to pay $350 million up front to Philochem for worldwide rights to an experimental radiopharmaceutical to diagnose and treat prostate cancer. The agent, OncoACP3, has shown promise in a Phase 1 trial for diagnostic imaging of prostate cancer by accurately targeting tumors, Philochem said. The Swiss company, a subsidiary of…

SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised $135 million in a Series B round to advance its lead program in Stargardt disease into further clinical testing. The startup is built around a technology that’s meant to overcome a key limitation of current gene therapies. Scores of gene therapy…

Dive Brief: Health and Human Services secretary Robert F. Kennedy Jr., has abruptly fired all members of the committee guiding the Centers for Disease Control and Prevention’s vaccine recommendations, creating fresh uncertainty about the way the public health agency might scrutinize new and existing shots going forward.    In an op-ed published in the Wall…

Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is trying for an encore, debuting a successor company on Tuesday that’s carrying forward much of its previous work.  Called Antares Therapeutics, the startup is launching with $177 million in financing from nearly a dozen investors, among them previous backers Omega Funds…

The Food and Drug Administration has cleared a new treatment designed to protect infants from respiratory syncytial virus. Called Enflonsia and developed by Merck & Co., the drug is an antibody intended to prevent illness from RSV, which can be particularly severe in young children. It was approved on Monday for newborns and infants who…

Dive Brief: An experimental weight loss drug developed by Metsera helped people with obesity lose up to 8% of their body weight over five weeks in an early-stage clinical trial and showed signs it could be administered once monthly, the company said Monday.  The drug, code-named MET-233i, is one of many in development aimed at…

Today, a brief rundown of news involving Regeneron and Bluebird bio, as well as updates from Atai Life Sciences, Alto Neuroscience and UniQure that you may have missed. Regeneron Pharmaceuticals on Monday disclosed Phase 2 study results that it claimed suggest the addition of one or two of its experimental medicines to Novo Nordisk’s Wegovy might help…

The amount of funding going into biotechnology companies has fallen off over the last couple months, a trend the investment bank Jefferies pins on Trump administration policies aimed at gutting the agencies responsible for conducting and regulating drug research. Looking at financial data from FactSet, Jefferies analysts found biotech funding in May was down 57%,…

New drugs, however heralded, take time to embed into clinical care. Enhertu, the powerful antibody-drug conjugate from Daiichi Sankyo and AstraZeneca, was first approved in the U.S. in 2019, before the world had even heard of a novel coronavirus. This past weekend, results presented at the American Society of Clinical Oncology’s annual meeting showed its…

The Food and Drug Administration aims to roll out its new AI tool, called Elsa, “ahead of schedule and under budget,” according to Commissioner Marty Makary, who offered up the most information to date about the agency’s new tool and AI goals this week. After completing a pilot program of AI-assisted scientific reviews last month,…

Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ Muldoon. The 10-month-old infant headed home from a Philadelphia hospital this week, dressed in a celebratory cap and gown, after his life-threatening disease was successfully treated with a bespoke CRISPR therapy. While baby KJ is not cured, the treatment has stabilized…

Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and Sagimet Biosciences that you may have missed. Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug it’s developing for the kidney disease…

CHICAGO — Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industry’s largest licensing deals. One of those medicines, the antibody-drug conjugate Enhertu, again…

Dive Brief: After changing its name and focus, Cullinan Therapeutics is beefing up its autoimmune disease pipeline by licensing an experimental drug from China. The company will pay Genrix Bio $20 million up front for the rights to a bispecific T cell engager called velinotamig. Genrix is then eligible to receive as much as $692…

Dive Brief: The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings to the regulator in the future. The so-called platform technology designation issued to Sarepta is meant to streamline the development and evaluation process for gene…

Dive Brief: Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications. Camurus’ FluidCrystal technology is designed to methodically release a therapeutic drug substance into the body over a period of days or months. After an injection, the solution interacts…

An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company. The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed…

CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial. Results from this trial, named Amplitude, were released Tuesday at the American Society…

Dive Brief: An experimental protein-degrading drug from Kymera Therapeutics appeared safe and able to affect its intended target in an early-stage clinical trial, leading shares in the biotechnology company to climb by nearly 50%. Data from a Phase 1 study in healthy volunteers showed that all dose levels of Kymera’s therapy, KT-621, either completely or…

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future.  According to Vera, the…

CHICAGO — Funding cancer research isn’t usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the budget of the National Cancer Institute, the American Society of Clinical Oncology is finding itself forced to defend what is usually a bipartisan policy. “If implemented, these cuts would be devastating to the…

Too often, cancer has a way of evading treatment. Tumors that were held in check begin to spread anew, forcing doctors to try different drugs in a desperate race to keep malignant cells from multiplying. For a common type of breast cancer, this usually happens because of changes in a gene called ESR1. Mutations there…

The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals. The new vaccine, which Moderna will sell as mNexspike,…

AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly prescribed, two-drug regimen involving chemotherapy. The finding, detailed Saturday at the American Society of Clinical Oncology’s annual meeting, gives physicians a clearer choice for when…

Today, a brief rundown of news involving Astellas Pharma and Keros Therapeutics, as well as updates from Stealth Biotherapeutics, PepGen and Taysha Gene Therapies that you may have missed. Keros Therapeutics will stop developing its top drug in pulmonary arterial hypertension and lay off 45% of its staff while evaluating its next strategic steps, the…

Dive Brief: A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to approval in the U.S. When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to…

The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain. Moderna revealed in a statement Wednesday that the HHS had terminated the contract, which could have handed the company…

Dive Brief: Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress. Lab tests showed the patient had grade 4 liver transaminase elevations that “appear to be resolving” without hospitalization or medical treatment and have since fallen to less…

Dive Brief: Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights. ITeos has for years struggled to develop a cancer treatment that sufficiently impressed investors and its pharmaceutical partners. Two weeks ago, it said it was shelving its most advanced drug…

Dive Brief: GSK plans to seek approval of a new antibiotic for complicated urinary tract infections after the drug succeeded in a Phase 3 trial. An independent monitoring board recommended ending the study early based on the efficacy of the medicine, known as tebipenem HBr, GSK said Wednesday. It’s part of a class of antibiotics…

Dive Brief: The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their shots for the upcoming fall and winter season to target the “JN.1” strain, ideally a subvariant known as LP.8.1. The decision followed a vote by FDA advisers endorsing the JN.1 lineage as the preferred target, similar to the year before. Drugmakers Moderna…

A biotechnology startup developing drugs designed to eliminate troublesome proteins found outside of cells has raised $130 million to start its first clinical trial. The startup, GlycoEra, will use the Series B funds to generate initial clinical data for its lead program, an immune disease treatment dubbed GE8820. It intends to bring a second immune…

Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older. The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase…

Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as updates from UroGen Pharma, Altos Labs and BioNTech that you may have missed. A Food and Drug Administration advisory panel on Wednesday voted unanimously against expanding use of Pfizer’s Talzenna in prostate cancer. All eight committee members concluded Pfizer’s data weren’t…

Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace period for their products officially ends. The Danish drugmaker on Thursday said it’s launching a “Choose the Real Thing” campaign designed to alert consumers of the potential dangers of knockoff products. It’s also offering self-paying…

The House passed Republicans’ “big, beautiful bill” on Thursday in a razor-thin 215-214 vote, sending the legislation — which includes the most drastic overhaul to Medicaid since the program was founded — to the Senate for review. It’s a major victory for Republicans. The multi-trillion dollar package was at risk of collapse heading into the vote, given tension…

Sanofi has agreed to spend $470 million to take control of a young biotechnology company and its experimental drug for Alzheimer’s disease. The newly announced acquisition has Sanofi paying $8 for each share of Vigil Neuroscience it doesn’t already own, reflecting a premium of nearly 250% to the price Vigil shares traded at Wednesday afternoon….

For decades now, doctors tasked with diagnosing breast cancer have peered into microscopes and pored over slides, hunting for signs the tumor cells they’re studying harbor a protein known as HER2. A positive result meant they could deploy powerful drugs like Herceptin or Perjeta to knock the tumor into remission, vastly improving their patients’ prognosis….

A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend survival in people with a hard-to-treat form of lung cancer, according to clinical trial data made public Thursday. The Phase 3 trial enrolled 660 people with small cell lung cancer that has metastasized, and sought to show that using Tecentriq and…

Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called JN.1 coronavirus strain for the upcoming fall and winter seasons, maintaining guidance they gave last year. The advisory committee convened Thursday for the first time under the Trump administration, meeting two days after FDA leadership…

Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic form of multiple myeloma that often progresses into more severe blood cancer. Members of the Oncologic Drugs Advisory Committee voted 6-2 that the benefits of Darzalex’s use in high-risk smoldering multiple myeloma outweighed its risks….

ReproNovo, a biotechnology company specializing in reproductive medicine, has raised $65 million to advance two drugs it thinks could help address fertility issues in men and women. The Switzerland-based firm plans to use the new funds to run Phase 2 clinical trials of the drugs. The first, called leflutrozole, is designed to treat infertility in…