Today, a brief rundown of news involving Mitsubishi Tanabe Pharma and Bausch + Lomb, as well as updates from Roche, Viracta Therapeutics and X4 Pharmaceuticals that you might have missed. Investment firm Bain Capital agreed on Friday to acquire Mitsubishi Tanabe Pharma in a deal that values the nearly 350-year-old pharmaceutical arm of Japan’s Mitsubishi Chemical…
Sionna Therapeutics on Thursday raised $191 million in an initial public offering that will fund its plan to challenge Vertex Pharmaceuticals’ dominant cystic fibrosis franchise. The company sold nearly 10.6 million shares at $18 apiece, more than it projected in a filing earlier this week. It will start trading Friday on the Nasdaq stock exchange under the…
Dive Brief: Eli Lilly’s profit doubled in the fourth quarter as the Indianapolis-based drugmaker raked in revenue from diabetes and obesity drugs. Net income rose to $4.4 billion, or $4.88 a share, from $2.2 billion, or $2.42 a share, in the same period a year earlier, Lilly said Thursday. Non-GAAP earnings reached $4.81 billion, or…
Dive Brief: Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test different doses and longer duration of treatment, the company said Wednesday. The announcement comes six weeks after the Denmark-based company released data from another Phase 3 trial that underperformed executives’ expectations on weight loss. Other…
Dive Brief: Sales of both GSK’s and Pfizer’s vaccines for respiratory syncytial virus dropped significantly in the last three months of 2024, compared the same period one year before. In a earnings report Tuesday, Pfizer said sales of its vaccine Abrysvo fell 62% year over year in the fourth quarter. The company attributed the drop…
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Robert F. Kennedy Jr. made Senator Bill Cassidy a raft of promises to secure the Louisiana Republican’s support in a key committee vote Tuesday that advanced Kennedy’s nomination as health secretary. According to Cassidy, who spoke on…
Dive Brief: Merck & Co. said Tuesday it is pausing shipments to China of its human papillomavirus vaccine Gardasil to ease rising inventory at its marketing partner amid an extended slump in demand. As a result, company executives said they are no longer setting a target of $11 billion in Gardasil sales by 2030. The…
Dive Brief: Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer without their disease worsening than those who got the typical care alone in a Phase 3 trial, the company said Monday. The result confirms earlier research from the study, called Breakwater, which had shown that…
In a little more than a week’s time, a drug developed by a small psychedelics company was able to significantly curb hard-to-treat depression in a mid-stage clinical trial. That’s according to high-level results announced Monday. The trial recruited 81 people with treatment-resistant depression and evaluated them via a widely used, 60-point scale where larger scores…
Dive Brief: Cell therapy developer Cargo Therapeutics will scrap its top program and lay off half of its staff after study results showing the treatment, which was being tested in a form of lymphoma, doesn’t have a “competitive risk-benefit profile,” the company announced Wednesday. Cargo said safety concerns observed in Phase 2 testing of the…
Dive Brief: 23andMe said Tuesday it is exploring “strategic alternatives,” which could include the sale of the company, a business combination or restructuring. The genetic testing company ended 2024 with $79 million and told investors it will need to raise money to fund its operations and financial commitments. CEO Anne Wojcicki tried to take the…
Robert F. Kennedy Jr., President Donald Trump’s health secretary nominee, showed limited knowledge about Medicare during his second confirmation hearing on Thursday. It was the second time in two days Kennedy appeared confused about the massive insurance program, which covers more than 66 million Americans. During a Senate Finance Committee hearing Wednesday, Kennedy also fumbled…
The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration approved a new, highly anticipated drug from Vertex Pharmaceuticals. The culmination of decades of work, Vertex’s Journavx is now cleared to treat the short-lived “acute” pain usually felt after an accident or a surgery. Vertex…
For the last quarter century, one of the world’s most capable drug developers toiled to make a new, non-addictive kind of painkiller. The journey was fittingly excruciating. Pain, as Vertex Pharmaceuticals found out, is wildly complex. It starts simple enough, with a sliced hand or burned finger or broken bone. But it convolutes fast. Special…
Today, a brief rundown of news involving Novartis and AbbVie, as well as updates from Biogen, Merck & Co. and Sanofi that you may have missed. Novartis on Friday reported fourth quarter and full year results that beat analyst forecasts, driven by sales growth for a range of products including the heart drug Entresto, cholesterol-lowering…
Metsera and Maze Therapeutics are the second and third biotechnology firms this year to go public, raising $275 million and $140 million, respectively, in a pair of new stock offerings priced Thursday. Metsera, an obesity drug developer, sold nearly 15.3 million shares at $18 apiece in an offering that ranks as one of the industry’s…
Takeda CEO Christophe Weber plans to retire next year after a decade steering the Japanese drugmaker, a tenure in which he led Takeda through one of the largest pharmaceutical mergers in history and a major research and development revamp. Julie Kim, currently president of the company’s U.S. business unit, will succeed Weber, backed by a…
Robert F. Kennedy Jr. on Wednesday told U.S. lawmakers that, if confirmed as the nation’s health secretary, he would support policies from President Donald Trump that would restrict abortion. As head of the Department of Health and Human Services, Kennedy would have broad power over agencies that impact abortion access in the U.S., including the…
Dive Brief: Novo Nordisk on Tuesday won an expanded approval for Ozempic, allowing the company to market its top-selling medicine to reduce the risk of kidney complications in adults with type 2 diabetes and chronic kidney disease. Ozempic is the first GLP-1 drug to win Food and Drug Administration approval for use protecting kidney health….
Multiple lawmakers in Congress reported Tuesday that states were shut out of Medicaid payment portals after the Trump administration enacted a freeze on all federal financial assistance — despite a new White House fact sheet saying Medicaid is not subject to the pause. Medicaid portals were down in all 50 states, according to a Tuesday…
The Food and Drug Administration on Monday expanded use of AstraZeneca and Daiichi Sankyo’s Enhertu, allowing the drug to be given earlier and more broadly in people with an aggressive form of breast cancer. Since 2022, Enhertu has been approved in the U.S. to treat advanced breast tumors expressing “low,” but still detectable, levels of…
Dive Brief: Sage Therapeutics’ board of directors has turned back partner Biogen’s opportunitistic attempt at a takeover, unanimously rejecting a $469 million offer from Biogen it said “significantly undervalues” the company. Earlier this month, Biogen proposed to buy Sage for $7.22 per share, which represented about a 30% premium to Sage’s share price at the…
Cell & gene therapy stands at the forefront of modern medicine, promising transformative treatments for previously intractable diseases. But, as the field continues to advance, a growing body of evidence suggests that we may need to fundamentally rethink one of the most basic aspects of cell culture: O2 concentration. While the field has made remarkable…
Neil Kumar has for years contended his unorthodox drug company is overlooked by biotechnology investors. He may not have that problem for much longer. The company he leads, BridgeBio Pharma, is in the early stages of launching a treatment for a heart condition called transthyretin amyloidosis with cardiomyopathy. Though the drug, Attruby, isn’t BridgeBio’s only…
Prominent vaccine skeptic Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Jan. 29 as he attempts to calm concerns from Democrats and Republicans about his nomination to be the nation’s top health official. Though controversy has surrounded a number of Trump’s nominees, Kennedy stands out for drawing criticism from both sides…
As the first major drug industry conference each year, the J.P. Morgan Healthcare Conference is regularly described as a barometer of expectations for the year ahead. This year, JPM delivered the dealmaking analysts and investors always say they hope to see: Johnson & Johnson agreed to buy Intra-Cellular Therapies for nearly $15 billion, while GSK and…
Dive Brief: An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development. Novo said Friday it is planning…
Sara Brenner, a Food and Drug Administration official within the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made to a webpage listing leadership biographies. The FDA declined to comment, citing a communications pause imposed by the Department of Health and Human Services, which oversees the drug agency. …
Today, a brief rundown of news involving Merck & Co. and AstraZeneca, as well as updates from AbbVie, Stealth BioTherapeutics and Vigil Neuroscience that you may have missed. A regimen of cancer drugs Keytruda and Lenvima extended progression-free survival over standard chemotherapy in people with a type of gastroesophageal tumor, but did not show an…
Dive Brief: Ascentage Pharma, a cancer drug developer based in Suzhou, China, on Thursday raised just over $126 million in the first U.S. initial public offering by a biotechnology company this year. The company, which is already publicly traded in Hong Kong, sold 7,325,000 American depositary shares at $17.25 apiece, a lower price than it…
Artificial intelligence was a topic of focus for the medical device industry in 2024. Companies including GE Healthcare, Medtronic and Dexcom touted new AI features, and others like Stryker and Quest Diagnostics added AI assets through M&A. Meanwhile, conversations about regulations and generative AI, models that are trained to create new data including images and…
Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing. The changes are the result of a redesign under the Inflation Reduction Act to Medicare’s Part D benefit, which covers…
Moderna will receive some $590 million from the U.S. government to develop messenger RNA vaccines for influenza strains, such as H5N1, that are seen as potential pandemic risks. Announced Friday as one of the Biden administration’s final acts, the funding commitment is through the Biomedical Advanced Research and Development Authority, or BARDA, an arm of…
Dive Brief: The Food and Drug Administration on Friday approved AstraZeneca and Daiichi Sankyo’s Datroway for use in people with a common type of breast cancer that has advanced despite two earlier lines of treatment. Datroway, previously known as datopotamab deruxtecan or dato dxd, is cleared for people whose breast tumors are HR-positive and HER2-negative,…
Dive Brief: Two biotechnology startups on Friday revealed plans to launch initial public offerings, extending a step-up in IPO activity among privately held drug companies. Sionna Therapeutics is working on therapies for cystic fibrosis, several of which are in early-stage testing. Odyssey Therapeutics aims to tap Wall Street to develop targeted drugs for immune diseases, the…
Dive Brief: The Food and Drug Administration needs stricter standards for the accelerated approval process to ensure patients and the healthcare system don’t waste money on ineffective treatments, according to a report issued Tuesday from a federal watchdog Spurred by controversy over the 2021 approval of Biogen’s Alzheimer’s disease drug Aduhelm, the office of the…
This week, the J.P. Morgan Healthcare Conference has brought a torrent of updates from drugmakers large and small. We’re highlighting a few here, but for the rest check out our reporters’ coverage from San Francisco here and here. Also below are news from Johnson & Johnson and Lykos Therapeutics. Johnson & Johnson on Wednesday said…
SAN FRANCISCO — With the close of J.P. Morgan Healthcare Conference, attention turns to next week’s inauguration of President-elect Donald Trump, and what his administration might mean for the Food and Drug Administration and the Department of Health and Human Services. By and large, pharma executives and investors here are largely saying they remain confident…
Roche has a big problem. With competition threatening some of its older and most lucrative biologic drugs, the Swiss pharmaceutical giant expects that, between 2023 and 2028, sales from these assets will have declined by roughly $8 billion. Despite this looming danger, Roche’s leaders have, at least publicly, put on a brave face. They’ve reshaped…
Today, a brief rundown of news involving Novo Nordisk and AstraZeneca, as well as updates from Amgen, Atara Biotherapeutics and Boehringer Ingelheim that you may have missed. A high-dose form of Novo Nordisk’s obesity drug Wegovy, together with lifestyle intervention, led to greater weight loss over 72 weeks than the current approved dose, according to…
Medicare’s next drug price negotiations will treat Novo Nordisk’s semaglutide as a single product, regardless of whether the metabolic disease medicine is used to treat diabetes or heart risk, and whether it is delivered by shot or pill. Semaglutide was one of 15 drugs the Centers for Medicare and Medicaid Services selected Friday for a…
Semaglutide, the popular drug sold by Novo Nordisk as Ozempic for diabetes and Wegovy for weight loss, is among a group of widely used medicines selected by the U.S. government for the next round of price negotiations under a 2022 law aimed at curtailing pharmaceutical costs within Medicare. The Biden administration released the list of…
Soon after starting a new biotechnology company, David Li realized he needed to rethink his strategy. Li had been conducting the competitive research biotech entrepreneurs typically undertake before soliciting investment. He drew up a list of drug targets that his startup, Meliora Therapeutics, could pursue and checked them against the potential competition. Li quickly found…
Dive Brief: Eli Lilly won Food and Drug Administration approval to sell its Omvoh medicine for adults with Crohn’s disease, adding to the potential market for a drug first approved in 2023. Omvoh is already available for adults with ulcerative colitis, a more common form of inflammatory bowel disease. Overall, IBD affects about 2.4 million…
On Tuesday morning, Biogen hosted an event for Wall Street analysts to better understand the company. One of the key topics discussed, according to Brian Abrahams of RBC Capital Markets, was business development. Biogen’s top drugs have been on the decline, and sales from its newest treatment for Alzheimer’s disease have yet to impress some…
Dive Brief: Eli Lilly on Tuesday said the company’s revenue in 2024 totaled about $45 billion, a 32% jump on 2023’s total but less than what it had estimated in October. Third quarter sales of Mounjaro and Zepbound, its GLP-1 drugs for diabetes and obesity, were below Wall Street analysts’ expectations at $3.5 billion and…
For any hopes the dealmaking that started the J.P. Morgan Healthcare Conference would give the overall biotechnology sector a running start to 2025, Eli Lilly deflated them Tuesday. The company, which rose to new heights on the success of its medicines for weight loss and diabetes, revealed revenue numbers that for the second time in…
As 2025 begins, emerging biotechnology firms can be sorted into two groups: haves and have-nots. Venture funding rose last year, but a good portion of that money was concentrated into nine-figure “megarounds” that became more common. Initial public offerings were primarily open only to companies that fit a certain profile. And among already public U.S….
Every January, the Westin St. Francis in San Francisco is, for a few days, the center of the universe for the healthcare industry. It’s the site of the J.P. Morgan Healthcare Conference, where hundreds of companies pitch investors, negotiate deals and plan for the year ahead. The convergence of thousands of executives in one location…
Eli Lilly has turned to a biotechnology startup for help building its pipeline of cancer drugs, agreeing on Monday to purchase an experimental cancer drug from privately held Scorpion Therapeutics for as much as $2.5 billion. As part of the deal, Scorpion will spin out a new, independent company that will hold its other assets…
Genetic medicine startup Tune Therapeutics has raised another $175 million to develop therapies capable of “tuning” genes to treat disease, rather than editing them by cutting or replacing DNA directly. Tune disclosed the Series B round on Sunday, the eve of the J.P. Morgan Healthcare Conference, which regularly features as a curtain-raising meeting for the…
Typically, the election of a Republican to the White House is welcome news for the biotechnology and pharmaceutical sectors. The incoming administration is a more uncertain prospect, however. President-elect Donald Trump has signaled disruption with unorthodox nominations for key healthcare roles, and could throw support behind policies disliked by drugmakers. Such political risks come at…
Dive Brief: Ouro Medicines, a new biotechnology startup, launched Friday with $120 million in funding to develop antibody drugs for chronic inflammatory conditions. Ouro plans to use so-called T cell engagers to rebalance the immune systems of people with autoimmune diseases. The company’s top prospect, licensed from China-based Keymed Biosciences, will begin clinical testing this…
Patrizia Cavazzoni, an influential Food and Drug Administration official who oversees much of the agency’s drug review work, will leave her role next week, according to an email sent to staff. Her departure follows announcements by several other high-ranking FDA leaders of plans to depart the regulator ahead of the coming change in presidential administration. Namandjé…
Today, a brief rundown of news involving Pfizer, AbbVie and Royalty Pharma, as well as updates from Biogen and Alkeus Pharmaceuticals that you may have missed. Pfizer on Friday said its PD-1 inhibitor sasanlimab, when combined with standard therapy in people with bladder cancer, delayed death and disease complications longer than standard therapy alone. The…
Dive Brief: Intellia Therapeutics will stop work on one of its principal drug research programs and lay off more than one-quarter of its staff in a restructuring meant to prioritize resources around its two most advanced experimental medicines. The discontinued program, dubbed NTLA-3001, targets a rare lung disease known as alpha-1 antitrypsin deficiency. Intellia had…
IGM Biosciences will scrap its top two drugs and lay off nearly three-quarters of its workforce after reporting study results that fell short of the company’s expectations. In an announcement Thursday, IGM said it halted development of experimental therapies known as imvotamab and IGM-2644 that were being tested in autoimmune conditions. IGM is doing so…
Maze Therapeutics on Tuesday filed plans for an initial public offering that could become the biotechnology sector’s first of the year, depending on how quickly the deal comes together. If Maze is successful, its IPO would continue a trend that has favored initial stock sales by biotechs with drugs already in clinical testing. More than…
GSK’s and Pfizer’s vaccines for respiratory syncytial virus must carry labels warning of a possible increased risk of a rare neurological disorder, the Food and Drug Administration said Tuesday. The FDA has not determined a causal link between the shots and the condition, called Guillain-Barré syndrome, or GBS. The agency also reaffirmed that the benefits…
Dive Brief: Privately-held biotechnology startup Metsera said Tuesday a long-acting GLP-1 shot it’s developing helped people who are overweight or have obesity lose more weight than placebo recipients in a Phase 2 trial. Study participants who received the shot, dubbed MET-097i, lost on average 11% more of their body weight than those who got a…
Dive Brief: Vertex Pharmaceuticals will work together with Orna Therapeutics over the next three years to develop technology that would help enable “in vivo” gene therapies for sickle cell disease and beta thalassemia. Under the deal announced Tuesday, Vertex will pay Orna $65 million upfront, a sum that includes an investment via a convertible note….
A landmark study hoping to find new treatments for ALS has notched two more failures, as experimental medicines from Denali Therapeutics and Calico Life Sciences proved no better than a placebo at slowing the nerve-destroying disease or keeping patients alive longer. Denali disclosed high-level results from the study Monday. After about six months, treatment with…
About four years ago, Sheldon Koenig was thinking about retiring. After spending decades in leadership roles at different pharmaceutical companies, he’d led a successful career focused largely on cardiovascular therapeutics. Along the way, he’d endured his own personal challenges with health—including a battle with cancer, which led him to discover he also had high cholesterol….
Dive Brief: Orbis Medicines, a European biotechnology startup, has raised 90 million euros, or about $93 million, in a Series A round announced Monday that will fund development of oral peptide drugs. Orbis is focused on “macrocycles,” a class of medicines that blends the strengths of small molecule and biologic drugs. The company aims to…
The Food and Drug Administration ended 2024 with a quartet of notable drug approvals, including three of new medicines that Vertex Pharmaceuticals, Novo Nordisk and Bristol Myers Squibb developed for cystic fibrosis, hemophilia and cancer, respectively. The approvals concluded a year in which the agency’s main review office cleared 50 novel medicines, less than the…
Neumora Therapeutics, a well-funded biotechnology company, lost more than 80% of its value Thursday because its most advanced drug failed a major test. After seeing positive signs in a smaller study in 2023, Neumora pushed the drug into a trio of late-stage clinical trials to evaluate it as a treatment for the most common type…
Happy New Year! We hope you had a restful holiday; If you took a break from keeping up with biotech news, we’ve got you covered with a brief rundown of the most important updates from the past week and a half. Pfizer won’t move forward with asking regulators to approve a gene therapy for hemophilia…
Incretin drugs have been so successful in clinical testing they’re akin to a pharmaceutical Swiss Army knife. Already, medicines from Novo Nordisk and Eli Lilly approved to treat obesity and diabetes have proven beneficial for heart failure, sleep apnea and kidney disease. A trial expected to produce results sometime this year could determine whether incretins…
The Food and Drug Administration on Thursday reaffirmed its assessment that Mounjaro and Zepbound, popular drugs for diabetes and obesity, are no longer in shortage, The agency’s decision will largely prevent so-called compounding pharmacies from making off-brand copies of the drug, closing a lucrative market niche that had opened as Eli Lilly, the drug’s maker,…
Swiss pharmaceutical company Novartis plans to close MorphoSys sites in the U.S. and Germany in a “strategic decision” that will affect 330 jobs. The move, which was first reported by the German magazine WirtschaftsWoche, stems from Novartis’ evaluation of its R&D priorities and the time needed to determine an approval path for MorphoSys’ drug pelabresib…
Vertex Pharmaceuticals lost more than $15 billion in value Thursday as new data on its closely watched pain drug disappointed Wall Street. The medication is meant to be a non-addictive alternative to opioids, and has shown in multiple clinical trials the ability to alleviate acute pain as well as a form of chronic nerve pain….
Dive Brief: Regeneron Pharmaceuticals intends to advance two blood-thinning drugs into Phase 3 testing next year after mid-stage study results showed they matched or surpassed marketed medicines at preventing blood clots following knee replacement surgery. Regeneron’s drugs block a clotting protein, Factor XI, that’s been targeted by multiple pharmaceutical companies, some of which have candidates…
KdT Ventures is launching a new biotechnology startup based on a drug it’s licensing from NGM Biopharmaceuticals, the companies announced Thursday. The deal hands the Austin-based venture firm’s currently unnamed startup worldwide rights to an experimental drug called NGM313, which will be developed for an unspecified rare disease. NGM Bio will get a stake in…
Today, a brief rundown of news involving Ionis Pharmaceuticals and the Food and Drug Administration, as well as updates from Zealand Pharma, Sangamo Biosciences and Novartis that you may have missed. The Food and Drug Administration on Thursday made Ionis Pharmaceuticals’ Tryngolza the first approved treatment in the U.S. for a rare and potentially life-threatening…
A new type of obesity drug being developed by Novo Nordisk has fallen short of expectations set by the company in a closely watched Phase 3 trial, causing shares to lose nearly a fifth of their value in early trading on Friday. In a statement, Novo said that the drug, a combination therapy called cagrisema,…
An experimental drug for Parkinson’s disease that Roche has been developing for more than a decade just flunked another key clinical trial. But in spite of those failures, the drug’s future isn’t clear. Roche’s Chief Medical Officer, Levi Garraway, said in a statement Thursday there were enough positive signs in the latest results to “merit…
David Epstein was ready to retire when an opportunity came along he couldn’t pass up. Epstein had just sold Seagen, a large cancer drugmaker, to Pfizer for $43 billion and thought it a fitting capstone to a career that included stops at Novartis and Flagship Pioneering. Like others winding down work in the life sciences,…
Dive Brief: Merck & Co. has made its first big move in obesity treatment, announcing Wednesday it is paying Hansoh Pharma $112 million for rights outside China to a preclinical pill that works similarly to the popular injection Wegovy. Per deal terms, China-based Hansoh could receive up to $1.9 billion in additional payouts based on…
Dive Brief: Doctors could have a new treatment option for protecting newborn infants from respiratory syncytial virus if the Food and Drug Administration approves Merck & Co.’s drug clesrovimab by next summer. Merck said Tuesday the agency had set a decision deadline of June 10, 2025, which would allow the company to launch the antibody…
Namandjé Bumpus, the Food and Drug Administration’s second-in-command, will depart the regulator at the end of the year, according to an email FDA Commissioner Robert Califf sent to agency staff on Tuesday. Bumpus has served as principal deputy commissioner since February 2024, when she succeeded longtime agency leader Janet Woodcock. Previously, Bumpus was the FDA’s…
Dive Brief: Edgewise Therapeutics plans to meet with regulators in the U.S. and Europe to discuss how much clinical trial evidence it needs to seek expedited approval of its experimental drug for a form of muscular dystrophy known as Becker. On Monday, the Colorado-based biotechnology company disclosed results from a Phase 2 study that showed…
Jazz Pharmaceuticals on Monday said it will begin searching for a successor to CEO Bruce Cozadd, who plans to retire from the company he helped start more than two decades ago. Cozadd will stay on as CEO until Jazz finds his replacement, after which he plans to continue serving as chair of the Dublin-based drugmaker’s…
Cell & gene therapy stands at the forefront of modern medicine, promising transformative treatments for previously intractable diseases. But, as the field continues to advance, a growing body of evidence suggests that we may need to fundamentally rethink one of the most basic aspects of cell culture: O2 concentration. While the field has made remarkable…
Research into women’s health has long gone underfunded in the U.S. But there’s some optimism that might be changing, attendees to the first conference hosted by the White House on women’s health research said Wednesday. Both President Joe Biden and first lady Jill Biden spoke at the conference, which featured panels involving investors, physicians, advocates…
Dive Brief: AbbVie will pay $200 million to acquire privately held Nimble Therapeutics and its pipeline of oral peptide drugs for immune diseases like psoriasis and inflammatory bowel disease, the pharmaceutical company said Friday. Chief among that pipeline is an oral therapy designed to inhibit a protein called IL-23, the same target of AbbVie’s blockbuster…
Today, a brief rundown of news involving Gilead and Padlock Therapeutics, as well as updates from Boundless Bio, Lonza and Bausch + Lomb that you may have missed. Investors of Padlock Therapeutics have sued Bristol Myers Squibb for allegedly refusing to make milestone payments tied to its 2016 acquisition of the biotechnology startup, Endpoints News first reported….
A panel of experts convened by the Food and Drug Administration called for more data to be collected on the safety of vaccines for respiratory syncytial virus in infants, indicating caution after the agency partially paused enrollment of clinical trials testing certain RSV shots in young children. The advisory committee, which met at the FDA’s…
In a rare move, the U.S. agency behind Medicare is warning insurers who provide Medicare Advantage plans that they can’t automatically deny coverage of Qalsody, a Biogen drug approved to treat amyotrophic lateral sclerosis. Medicare Advantage, or MA, plans are a privatized form of Medicare, the federal health insurance program for people aged 65 or…
The Food and Drug Administration has identified additional safety concerns associated with use of a drug used to treat a rare liver condition in the latest sign of trouble for a medicine once seen as a future blockbuster. The agency on Thursday said it’s found cases of serious liver injury among patients with the rare…
Dive Brief: Editas Medicine will lay off 180 employees, or about two-thirds of its workforce, over the next six months as part of a broader pivot to focus its drug research on “in vivo” gene editing, the biotechnology company said Thursday. In October, Editas revealed plans to change course, announcing that it would seek to…
Dive Brief: Shares of Q32 Bio lost two-thirds of their value Wednesday after the company reported disappointing study results for an experimental medicine in two indications. The drug, bempikibart, is an antibody designed to interfere with two cytokines that play a role in immune function. In the two trials Q32 Bio reported late Tuesday, researchers…
An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people with a form of HER2-negative, ER-positive disease stay alive and progression free for longer than standard hormone-suppressing therapies, according to data disclosed Wednesday. When combined with Lilly’s approved medicine Verezenio, the experimental drug, called imlunestrant,…
Shares of UniQure doubled Tuesday morning after the Netherlands-based biotechnology company trumpeted that its experimental treatment for Huntington’s disease could be eligible for a speedy kind of approval. Known as AMT-130, the treatment is one of UniQure’s most advanced and closely watched assets. It’s a gene therapy designed to enter brain cells and block the…
The American Society of Hematology’s annual meeting continued Monday with important presentations and discussions on the latest blood disease research, several of which we’ve summarized here. Sequencing BTK inhibitors in leukemia In the years since the approval of Imbruvica for chronic lymphocytic leukemia a decade ago, it and other so-called BTK inhibitors have become mainstay…
One year on from the landmark U.S. approval of two powerfully effective gene therapies for sickle cell disease, the treatments have been barely used, a sluggish start that reflects the myriad challenges of launching them. While some five dozen people with the blood disorder have begun the treatment process for one or the other therapy,…
This weekend, thousands of researchers and physicians descended on San Diego for the American Society of Hematology’s annual meeting. While BioPharma Dive wasn’t on site this year, we’ve summarized a few of the most notable datasets from the past two days below. Darzalex in smoldering multiple myeloma Johnson & Johnson and Genmab’s multiple myeloma drug…
Contract development and manufacturing in the Asia-Pacific (APAC) market is poised for explosive growth. The region has been the focus of significant expansion, and the market size is expected to top $108 billion by 2029. Outsourcing trends, increased healthcare expenditure and demand for injectable drugs and cell and gene therapies have made clinical services organizations…
Inside every human cell are thousands of snippets of genetic code that serve as the directions for creating proteins. And over the past four years, a small biotechnology company has been trying to prove that, by looking closely enough at this assembly of instructions, it can find new ways to treat diseases like Alzheimer’s, Parkinson’s…
Today, a brief rundown of news involving Daiichi Sankyo, Agenus and Amgen, as well as updates from the U.S. PTO, Bluebird bio and Merus that you may have missed. AstraZeneca and Daiichi Sankyo on Friday revealed new study results supporting their revised approval plans for the closely watched cancer drug datopotamab deruxtecan, or dato-dxd. A…
Dive Brief: BioAge Labs said it is terminating a mid-stage study of its obesity drug candidate azelaprag in combination with Eli Lilly’s tirzepatide due to safety concerns, causing its share price to slide by three-quarters in after-hours trading Friday. Eleven people who received azelaprag in STRIDES, BioAge’s Phase 2 study, showed elevated levels of liver…
Eli Lilly will spend $3 billion to expand a manufacturing facility in Wisconsin it bought in April, adding new capabilities to produce injectable medicines like its fast-selling weight loss and diabetes drugs Zepbound and Mounjaro, the company said Thursday. The expansion of the Kenosha County facility will be Lilly’s “single largest U.S. manufacturing investment” outside of…
Robert F. Kennedy Jr., chosen by President-elect Donald Trump to be the next health secretary, has made it his mission to dissipate what he describes as a “smothering cloud of corporate capture” within agencies like the Food and Drug Administration. In particular, he aims to target perceived conflicts of interest among health officials, a goal…
Biotechnology startup Nuvig Therapeutics is the latest emerging immune drug developer to attract investors’ attention, announcing Thursday a $161 million Series B round to bring its lead candidate into mid-stage testing. The company, which is based in Menlo Park, California, raised the funds from more than a dozen investors. It plans to use the cash…
Dive Brief: Atlas Venture said Thursday that it’s raised $450 million for its 14th fund, through which the firm will continue to seed and grow new biotechnology companies. Partner Bruce Booth called the fundraising round the smoothest and most efficient he’s seen in 20 years at the firm. “Given the level of demand, we could…
Dive Brief: Atea Pharmaceuticals said Wednesday that its experimental combination regimen to treat the hepatitis C virus succeeded in a Phase 2 trial, clearing the way for Phase 3 research to begin early next year. In the Phase 2 study, patients received a combination of bemnifosbuvir and ruzasvir for eight weeks, without any reports of…
Dewpoint Therapeutics, a young biotechnology company, could receive nearly half a billion dollars if all goes to plan in a new partnership focused on its experimental medicine for ALS. Through a deal announced Wednesday, Dewpoint has given Mitsubishi Tanabe Pharma the exclusive right to license the medicine once it hits certain near-term research and development…
Coherus BioSciences has reached a deal to sell another one of its biosimilars as part of a plan to make cancer immunotherapies its focus going forward. The company on Tuesday said it will divest its Udenyca franchise, the name for its copycat version of Amgen’s Neulasta, to India-based drugmaker Intas Pharmaceuticals. Intas has agreed to…
Shares of Janux Therapeutics surged to record highs following the release of study results for a drug that, if ultimately successful in testing, would represent a new type of therapy for prostate cancer. The findings come from an early-stage study testing the biotechnology company’s therapy, dubbed JANX007, in 16 people with a form of advanced…
Today, a brief rundown of news involving Novocure and Merus, as well as updates from Cytokinetics, Fate Therapeutics and Bluebird bio that you may have missed. Novocure said its electrical field-emitting device alongside chemotherapy helped people with locally advanced pancreatic cancer live longer than those who received only chemo in a Phase 3 trial. Trial…
The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss and diabetes drugs like Wegovy and Zepbound. The group on Monday released an official guidance statement that recommends doctors avoid prescribing unapproved, off-brand versions of the medicines, which have been so in demand their manufacturers,…
Evolving technology has helped advance the field of gene therapy, and today, more and more biopharmaceutical innovators are using groundbreaking approaches to treat diseases. Adeno-associated virus (AAV) vectors have emerged as a leading gene-delivery tool[1], with several AAV-based therapeutics approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). However, there…
Brain drug developer Alector is laying off staff after one of its most advanced experimental medicines failed to show enough promise as a treatment for Alzheimer’s disease. For the past few years, researchers have been testing the medicine, known as AL002, in a clinical trial that enrolled close to 400 participants with early-stage Alzheimer’s. Results…
Swiss pharmaceutical giant Roche is spending around $1 billion to acquire a San Diego-based biotechnology company that’s trying to treat certain cancers and rare diseases with a slate of cell therapies and genetic medicines. The deal, announced Tuesday, has Roche paying $9 per share of Poseida Therapeutics. Poseida investors may additionally receive as much as…
Roche’s long-running bet on a new kind of cancer immunotherapy has, after years of shrinking optimism and second-guessing by analysts on Wall Street, come up empty — at least for now. On Tuesday, Roche said that much-anticipated results from a Phase 3 trial called SKYSCRAPER-01 showed the drug, tiragolumab, did not help people with advanced…
Today, a brief rundown of news involving Kronos Bio, Idorsia and PTC Therapeutics, as well as updates from Alnylam Pharmaceuticals and Soleno Therapeutics that you may have missed. Kronos Bio will lay off 83% of its workforce by year’s end and its CEO, Norbert Bischofberger, will step down effective Dec. 3, the company said Wednesday….
Dive Brief: Sarepta Therapeutics has turned to dealmaking to restock a drug pipeline analysts worried was growing thin, announcing Tuesday a deal with Arrowhead Pharmaceuticals that will give it four clinical-stage treatments and three others still in preclinical testing. In return, Sarepta will pay Arrowhead $500 million upfront and spend another $325 million to buy…
For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up being far off, then investors may question how well a developer understands its own business or the markets in which it operates. That’s especially true when the prediction is too high. Analysts on Wall Street…
Dive Brief: Amgen on Tuesday said its weight loss drug MariTide helped people with obesity lose up to 20% of their body weight over one year in a Phase 2 trial, paving the way for the company to initiate a larger study aimed at supporting U.S. approval. The weight loss Amgen reported for its monthly…
The Biden administration on Tuesday proposed a rule that would allow Medicare and Medicaid to cover weight loss drugs for patients with obesity. The rule — if kept by the incoming Trump administration — would dramatically expand access to drugs like Wegovy and Zepbound that have proven powerfully effective in helping people lose weight. But…
Dive Brief: An experimental, muscle-preserving drug from Biohaven fell short of its goal in a Phase 3 study of people with spinal muscular atrophy, but showed enough promise in its effects on body composition that the company plans to advance it as a treatment for obesity. A regimen of Biohaven’s drug, taldefgrobep alfa, and a…
Dive Brief: Adding Merck & Co.’s new cardiovascular drug Winrevair to background therapy helped people with severe lung hypertension stay alive and avoid invasive medical care longer than those who only received background therapy, the company said Monday. Data from the ZENITH trial could potentially expand use of a drug that’s now forecast to earn…
Howard Chang, a top biotechnology researcher and longtime professor at Stanford University, will join Amgen as chief scientific officer on Dec. 16, the company said Wednesday. Chang will also assume the title of senior vice president of research and will report to Jay Bradner, the executive vice president of research and development who currently serves…
Retail pharmacy giants have been straining under the intense headwinds hitting the industry this year — and Walgreens’ most recent earnings provided another case in point. The company said in October that it plans to close about 1,200 lower-performing stores over the next three years, citing changing consumer habits, rising competition from chains like Walmart…
Dive Brief: Lexicon Pharmaceuticals will lay off 60% of its workforce and eliminate its commercial organization in a restructuring meant to save $100 million in operating costs next year. The shakeup follows Lexicon’s receipt of a letter from the Food and Drug Administration that cited “deficiencies” in the company’s approval application for its diabetes drug…
The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio Pharma, and teeing up a battle for control of a lucrative market targeted by several drugmakers. The agency on Friday cleared Attruby, known scientifically as acoramidis, for people with a cardiac form of transthyretin amyloidosis,…
President-elect Donald Trump on Friday named Johns Hopkins University surgeon Marty Makary to lead the Food and Drug Administration, choosing a prolific medical researcher who bucked consensus on the necessity of frequent vaccination during the COVID-19 pandemic. As FDA commissioner, Makary would oversee an agency of some 18,000 employees who assess new drugs and devices,…
Today, a brief rundown of news involving Halozyme and Neurogene, as well as updates from Argenx and Kura Oncology that you may have missed. Halozyme Therapeutics on Friday said it withdrew an offer to buy Evotec after the German drug discovery and contracting company refused to engage in acquisition talks. Halozyme sought to buy Evotec…
Through a new deal, Novartis has added a handful of experimental gene therapies to its neuroscience research pipeline. Novartis is betting the gene therapy technologies developed by Kate Therapeutics, a biotechnology startup founded four years ago, can lead to treatments for an array of neuromuscular diseases. The Swiss pharmaceutical giant said Thursday it has acquired…
Drug development is an expensive, risky endeavor. Biotechnology companies just starting out are many years away from seeing profits, if ever. So more often than not, a startup’s success turning science into medicines can come down to how much money it raises. That’s where venture capitalists step in, investing many millions of dollars for stakes…
Pfizer on Wednesday said it will promote Chris Boshoff to chief scientific officer and president of research and development as the giant drugmaker struggles to win back the faith of investors. Boshoff will assume his new post on Jan. 1, succeeding Mikael Dolsten, who oversaw research at Pfizer for 15 years. The company announced Dolsten’s…
Sage Therapeutics is shelving one of its most important experimental drugs, after a last-ditch effort to prove it can be useful in nerve-destroying disorders ended in failure. On Wednesday, Sage disclosed the drug, known as dalzanemdor or SAGE-718, didn’t meet any of the key goals of a mid-stage study focused on the cognitive impairment associated…
Today, a brief rundown of news involving Astellas and Cytokinetics, as well as updates from Cybin, Neurogene and Novartis that you may have missed. The Food and Drug Administration rejected a request by Astellas Pharma to update the prescribing information for its geographic atrophy drug Izervay, the company said Tuesday. According to Astellas, the FDA…
Dive Brief: An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday. The drugmaker plans to discuss data from the trial, which it didn’t disclose in full, with the Food and Drug Administration and other regulators….
Dive Brief: A single infusion of a CRISPR therapy developed by Intellia Therapeutics showed promising signs of stabilizing a heart disorder caused by the rare disease transthyretin amyloidosis, buoying the company’s hopes of finding success in late-stage clinical trials. Phase 1 study data from 36 people with the cardiomyopathy form of transthyretin, or ATTR, amyloidosis…
Dive Brief: Massachusetts-based Syndax Pharmaceuticals won Food and Drug Administration approval Friday for a new kind of drug to treat an aggressive form of leukemia in adults and some children. The oral drug, which Syndax will sell as Revuforj, is the first of its type, a class of compounds known as menin inhibitors. It’s cleared for…
Merck & Co. has bought into the kind of drug that has emerged as a top threat to its dominant cancer immunotherapy Keytruda. The company said Thursday it agreed to pay privately-held LaNova Medicines $588 million in cash for worldwide rights to a cancer therapy called LM-299, which is currently in Phase 1 testing in China….
In an unusual reversal, key drug regulators in Europe are now saying Leqembi, a high-profile medicine for Alzheimer’s disease, should be approved there, though only for patients less likely to experience a certain kind of concerning side effect. Leqembi’s primary developer, Japan-based Eisai, submitted a marketing application to the European Medicines Agency in early 2023….
Today, a brief rundown of news involving Evotec, Bluebird bio and the company formerly known as BeiGene, as well as updates from Leerink Partners and Abeona Therapeutics that you may have missed. Halozyme Therapeutics has made an unsolicited bid to buy drug discovery specialist Evotec for 11 euros per share in cash, an offer worth some…
Market downturns take a toll. For many young biotechnology companies, the past few years have been a lesson in survival, as the evaporation of the sector’s pandemic-era boom brought cutbacks to the investment they so desperately need. “Platform” companies, so called for their focus on broad drugmaking technologies rather than one or two specific medicines,…
Failure is more common than success for young biotechnology companies attempting to get a new drug onto the market. Drug development is rife with pitfalls, from disappointing clinical trial results to funding woes that can end a program prematurely. Companies should seek an edge by reducing risk, setting their would-be products apart and communicating clearly…
Trace Neuroscience, a freshly launched startup, is developing a type of genetic medicine it believes could help most, if not all, people with ALS. It’s a bold idea, considering nearly every attempt to combat the nerve-destroying disease has ended in failure. Researchers still aren’t sure what causes 90% of cases. And in the U.S., the…
President-elect Donald Trump plans to nominate Robert F. Kennedy Jr. to lead the Department of Health and Human Services in a controversial choice that would elevate the prominent vaccine skeptic to a position overseeing the nation’s leading health agencies, including the Food and Drug Administration and Centers for Disease Control and Prevention. Trump named Kennedy…
Dive Brief: PTC Therapeutics on Wednesday won Food and Drug Adminitration approval for Kebilidi, the first gene therapy cleared in the U.S. for direct administration to the brain. The treatment is designed for patients with aromatic L-amino acid decarboxylase, or AADC, deficiency, a condition that affects the way neurons transmit information to other cells. The…
Dive Brief: Metsera, already a well-funded biotech startup, added another $215 million to its coffers as investors responded to the promise of its obesity drug pipeline. Wellington Management and Venrock Healthcare Capital Partners led the latest round of financing, the company said Wednesday. New investors included “crossover” investors such as Fidelity Management & Research, Janus…
Today, a brief rundown of news involving Amgen and AstraZeneca, as well as updates from Roche, Novartis, and Centessa Pharmaceuticals that you may have missed. Amgen lost $12 billion in market value Tuesday after a Wall Street analyst published a note suggesting the company’s closely watched obesity drug MariTide might be associated with loss of…
Third Rock Ventures, the well-known backer of biotechnology companies, is leading a nine-figure fundraising round for a startup that aims to treat ALS by replacing broken genetic machinery. The startup, Trace Neuroscience, launched Tuesday with $101 million from an investment group that includes Atlas Venture, RA Capital Management and Alphabet’s venture capital arm, GV. Third…
Flagship Pioneering startup Vesalius Therapeutics has signed a deal with GSK, the companies announced Tuesday, for the British pharma to use its technology to find medicines for neurodegenerative disorders. Under the terms of the deal, GSK will hand Vesalius $80 million in upfront and equity payments. Vesalius will lead the drug discovery process to identify…
Through a recent, nearly $9 billion acquisition, AbbVie surged to the front of a new wave of antipsychotic drugs that Wall Street expects to become big sellers. But on Monday, the company’s plans came crashing down. AbbVie said the main asset it got from its purchase of Cerevel Therapeutics, an experimental medication called emraclidine, had…
Dive Brief: The Food and Drug Administration on Friday approved a new cell therapy for a type of leukemia. Called Aucatzyl, the CAR-T was developed by U.K.-based Autolus Therapeutics to treat people with B-cell precursor acute lymphoblastic leukemia whose disease has progressed following treatment with chemotherapy and other medicines. Aucatzyl will compete with Gilead Sciences’…
Acadia Pharmaceuticals agreed to sell a priority review voucher to an undisclosed buyer for $150 million, a price tag on the high end for the coveted passes that speed up Food and Drug Administration reviews of new medicines. The company won the voucher in March 2023, along with FDA approval of its Daybue treatment for…
Dive Brief: Sarepta Therapeutics is giving up on an experimental drug for Duchenne muscular dystrophy as sales rocket for its approved gene therapy for the disease. The decision to discontinue SRP-5051 was based on several factors, company executives told analysts on a conference call Wednesday. Safety concerns, feedback from the Food and Drug Administration and…
With the U.S. presidential election decided, one name is suddenly circulating in healthcare: Robert F. Kennedy Jr. President-elect Donald Trump has promised Kennedy a large role in his new administration, signaling he could be handed influence guiding some of the nation’s health policies. And Kennedy, who does not have medical or public health degrees, has…
Dive Brief: Athira Pharma, a small drugmaker focused on neuroscience, is looking into the different paths it could take to “maximizing stockholder value,” after the company’s most advanced experimental medicine flunked a key study. In early September, Athira disclosed high-level results from a clinical trial evaluating that medicine, known as fosgonimeton, in people with mild…
Today, a brief rundown of news from AstraZeneca, Amgen and Jazz Pharmaceuticals, as well as updates from Geron, Gilead Sciences and Avid Bioservices that you may have missed. AstraZeneca and Amgen’s drug Tezspire reduced nasal congestion and the size of nasal polyps versus placebo in a Phase 3 trial involving people with a form of…
Public biotechnology company AlloVir has agreed to merge with the privately held Kalaris Therapeutics, nearly one year after a clinical setback sunk its stock price and its options. Through a reverse merger announced Friday, the two companies will combine to create a new firm that will operate under Kalaris’ name and trade on Nasdaq with…
Dive Brief: Moderna on Thursday reported third quarter sales of its COVID-19 vaccine that substantially outperformed analyst expectations. The company didn’t raise its financial outlook for the year, however, suggesting revenue could decline over the last three months of 2024. From July through September, sales of the COVID shot Spikevax totaled $1.8 billion, about $600…
Donald Trump’s victory in the U.S. presidential election Tuesday means change is coming for federal health agencies and the industries they regulate. It’s just not quite clear yet how dramatic that change might be. Trump has pledged to “make America healthy again” and, in embracing Robert F. Kennedy Jr., a well-known critic of vaccines and…
Dive Brief: Dive Insight: Novo and Lilly are racing to build on their dominant obesity drug businesses. Both are working to broaden use of their therapies, while also working on newer medications that are meant to be more potent and tolerable for people to take. Analysts have estimated annual sales in the GLP-1 class that…
Research into RNA interference, a Nobel Prize-winning technique to mute disease-causing gene mutations, has gained momentum in recent years. Since 2018, six medicines based on the technology have won approval to treat a variety of rare diseases, as well as high cholesterol. Dozens more are in clinical testing. Yet the field’s best-known companies, led by…
Dive Brief: A cancer cell therapy developed by Arcellx and Gilead Sciences helped reduce or eliminate signs of multiple myeloma in 95% of people in advanced stages of disease, the companies said Monday. The data, from trial volunteers whose cancer progressed after prior treatment, compared well to the leading multiple myeloma cell therapy, Johnson &…
A medicine built around a more precise form of CRISPR gene editing appeared to work as designed in its first clinical trial test, developer Beam Therapeutics said Tuesday. But the death of a trial participant could renew concerns about an older drug used alongside Beam’s genetic medicine. Beam’s medicine uses a technology known as base editing…
Neurogene, a gene therapy developer focused on rare neurological diseases, has secured $200 million through a private funding deal that will extend its cash reserves into late 2027. The company on Monday signed an agreement to raise the funds in a so-called PIPE financing, a deal in which publicly traded entity sells shares to private…
As the third generation of PCR technology, digital PCR introduced powerful new capabilities to countless research applications. Features such as improved precision and sensitivity, absolute quantification of nucleic acids, and tolerance to common PCR inhibitors set digital PCR apart, but the introduction of Droplet Digital™ PCR (ddPCR™) technology pushed the field even further. For over…
Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges. Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices, racial bias in pulse oximeters, concerns about the recall process after Philips…
California biotechnology startup Evommune has raised $115 million to advance a pair of medicines it’s developing for chronic immune conditions. The Series C funding announced Thursday will support a trio of Phase 2 trials that should all produce results by the end of 2026. Evommune’s most advanced drug, a small molecule dubbed EVO756, is already…
Dive Brief: Compass Pathways said it will lay off 30% of its workforce, narrow its research focus and explore selling its digital technologies after pushing back the timeline for its lead medicine, a psychedelic treatment for depression. The company now plans to release topline data from a Phase 3 study known as COMP005 in the…
Today, a brief rundown of news from Regeneron Pharmaceuticals and Madrigal Pharmaceuticals, as well as updates from UCB, AbbVie and PTC Therapeutics that you may have missed. Shares of Regeneron Pharmaceuticals fell nearly 10% amid growing uncertainty about the future sales of its flagship Eylea franchise. Regeneron has been looking to a new high-dose version…
Novo Nordisk will seek regulatory approval of semaglutide, the key ingredient in its popular weight loss medicine, in a common liver disease following positive results in a Phase 3 trial, the company said Friday. Summary results disclosed in a press release show that semaglutide met both of its main goals in the first part of…
Dive Brief: Jade Biosciences, a privately held developer of immune disease drugs, will combine with Aerovate Therapeutics in a reverse merger that gives Jade a fast pass to trade on public markets. Prior to the merger, which the companies announced Thursday, Jade expects to raise $300 million via a private financing involving more than a…
Dive Brief: Roche may seek an accelerated U.S. approval of its experimental Alzheimer’s disease drug trontinemab if the therapy continues to show in testing it can significantly lower levels of a protein linked to cognitive decline, executives said in a presentation to investors Thursday. The Food and Drug Administration has been willing to grant speedy…
Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday. GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to…
All doses of Novo Nordisk’s popular GLP-1 medicines Ozempic and Wegovy are available in the U.S. and being regularly shipped to wholesalers, the drugmaker confirmed Wednesday. One dose form or another of both drugs, which respectively treat diabetes and obesity, has been in shortage since March 2022, according to a database maintained by the Food…
Archon Biosciences came about as most startups do, the result of happenstance and good timing. Unlike many, the biotechnology company also had a Nobel Prize winner to help it along. In 2019, James Lazarovits was researching nanotechnology at a University of Toronto lab when he fell upon computational protein design, a fast-evolving field preoccupied by…
Sales of Pfizer’s new vaccine for respiratory syncytial virus were lower in the third quarter than during the same period last year, but the company pointed to signs of growing market share as reason for confidence in the shot’s market potential. Between July and September, Abrysvo brought Pfizer $356 million in sales globally, compared to…
Dive Brief: Novartis will pay $150 million to gain rights to “molecular glue degraders” being developed by biotechnology company Monte Rosa Therapeutics to target an immune signaling protein, known as VAV1, that has long been considered “undruggable.” The deal, announced by the companies Monday morning, could yield up to $2.1 billion in further payments by…
AbbVie has agreed to acquire a young company with drugmaking technology from Johnson & Johnson and an experimental treatment for Alzheimer’s disease that’s in the first stage of human testing. The deal, announced Monday, is expected to close by the end of the year, and has AbbVie buying all the outstanding shares of Aliada Therapeutics…
Managing biospecimens is a critical, yet often overlooked, part of ensuring a clinical trial’s success. Biospecimen managers are a resource that provides full lifecycle biospecimen oversight, from collection to sample disposition or long-term storage of those specimens for future exploratory needs. But how exactly does a biospecimen manager help assure the integrity and efficiency of…
Dive Brief: Intellia Therapeutics on Thursday released detailed Phase 2 results from a study of a gene-editing therapy for hereditary angioedema, drawing mixed reactions from investors and experts. The therapy, dubbed NTLA-2002, is based on the CRISPR gene editing technology that won a Nobel Prize in 2020. The treatment is designed to inactivate a gene…
Dive Brief: Kivu Biosciences, a San Francisco-based biotechnology startup developing targeted drugs for cancer, has raised $92 million in a Series A round, the company said Monday. Kivu will use the funds to advance technology it claims can help address some of the current limitations of antibody-drug conjugates, or ADCs. Its technology, Kivu says, can…
A panel of advisers to the Centers for Disease Control and Prevention on Wednesday recommended lowering the age for routine pneumococcal vaccination from 65 to 50 years of age, boosting the sales potential for multiple shots on the market or in development. Committee members voted nearly unanimously to make the change, with the agency noting…
Today, a brief rundown of news from GSK and Amgen, as well as updates from Roche, AbbVie, and Marinus Pharmaceuticals that you may have missed. Amgen set a list price of $1,665 per shot for its biosimilar version of Regeneron’s Eylea, a 10% discount from the eye drug’s current wholesale cost, RBC analyst Brian Abrahams…
Sanofi reported a 25% boost in sales for its vaccines division during the third quarter, helped by earlier-than-anticipated orders of its flu shots as well as rising revenue from Beyfortus, its RSV antibody for infants. Announcing earnings Friday, the French pharmaceutical company said Beyfortus sales were 645 million euros, or about $700 million. Overall, Sanofi’s…
Septerna, a developer of medicines that target a ubiquitous family of proteins, on Thursday priced a $288 million initial public offering that again showed investors’ support of biotechnology companies that have reached clinical testing. The company sold 16 million shares at $18 apiece, slightly above the $15 to $17 range it had set in a…
Lyell Immunopharma, a cell therapy developer that has struggled to match its high profile, is acquiring a biotechnology startup and streamlining research in a bid to focus on a slate of cellular immunotherapies for cancer. The company on Thursday said it’s reached a deal to buy ImmPact Bio, a cell therapy startup that’s been focused…
In the world of drug discovery, a lot can change in 20 years. Over the past two decades, biotechnology companies brought to market a wave of biologic medicines that changed how many autoimmune diseases are treated. Cancer immunotherapy extended lives to a degree that previously wasn’t possible, and gene editing technology went from science fiction…
Alto Neuroscience, a young biotechnology company developing medicines for the brain, lost much of its value Wednesday as negative results from a clinical trial raised doubts about the future of its most advanced research program. That program revolves around an experimental drug code-named ALTO-100, which Alto is testing against different kinds of depression. The new…
The Food and Drug Administration on Tuesday named Michelle Tarver as the permanent director of the agency’s device center. Tarver was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Jeff Shuren stepped down. FDA Commissioner Robert Califf emphasized Tarver’s “passion about data, science, medicine, and the…
Thorsten Stafforst remembers being told to stop wasting his time. It was early last decade and scientists across the world were buzzing over a new tool, called CRISPR, that could precisely alter human DNA. Working in the German college town of Tubingen, Stafforst and fellow researchers at the local university were instead engrossed by the…
Dive Brief: French pharmaceutical company Sanofi is proceeding with plans to sell U.S.-based private equity firm Clayton Dubilier & Rice a controlling stake in its consumer health busines Opella, which would be valued at around 16 billion euros, or about $17.3 billion, in the deal. Under the proposed terms, CD&R would take a 50% stake…
The biopharmaceutical industry has been a hotbed of innovation in recent years, with an increasing number of novel recombinant protein therapeutics receiving the U.S. Food and Drug Administration’s (FDA) green light. However, these therapies are often very expensive, highlighting the ever-growing need for improved efficiency and productivity. One of the key levers in enhancing productivity…
Dive Brief: Sanofi will invest 300 million euros, or about $325 million, for a roughly 16% stake in a new joint venture set up to develop radiopharmaceutical drugs for rare cancers. The newly created entity will operate under the banner of Orano Med, a radiopharmaceutical developer and Sanofi’s partner in the joint venture. Orano Med,…
Dive Brief: CVS Health on Thursday replaced CEO Karen Lynch as the healthcare and pharmacy giant’s financial challenges mount. CVS’ new chief executive is David Joyner, a company veteran who most recently headed up CVS’ pharmacy benefit manager Caremark. Lynch, who held the top spot at CVS since 2021 and previously led insurer Aetna, stepped down “in…
Today, a brief rundown of news from PTC Therapeutics and Novartis, as well as updates from Amylyx Pharmaceuticals and Intercept Pharmaceuticals that you may have missed. Europe’s drug regulator is standing firm in its decision not to renew the marketing permit for Translarna, a treatment developed by PTC Therapeutics for a rare muscle-wasting disease. The…
Dive Brief: Gilead will no longer sell its combination drug Trodelvy to treat bladder cancer, announcing Friday it had agreed with the Food and Drug Administration to withdraw it following negative trial results. The FDA granted Trodelvy accelerated approval for bladder cancer in 2021, based on results that found it shrank tumors in people whose…
Dive Brief: An experimental antibody drug developed by Merck & Co. significantly reduced the incidence of disease due to respiratory syncytial virus infections as well as related hospitalizations in infants, the company said Thursday. Called clesrovimab, the antibody met all the goals of a Phase 2b/3 study testing it in more than 3,600 healthy pre-…
People with advanced Parkinson’s disease have a new treatment option, as the Food and Drug Administration on Thursday approved a combination therapy from AbbVie that’s designed to provide longer-lasting movement control. Parkinson’s is hallmarked by unintentional muscle movements like shaking or stiffness — the result of nerve cells progressively breaking down and dying. Two drugs,…
Sage Therapeutics is restructuring yet again, announcing Thursday a company shakeup that will involve layoffs for about one-third of its workforce and a reprioritization of its early-stage drug pipeline. Alongside the cuts, five senior executives will depart, including Sage’s top lawyer, CFO and chief technical officer. Overall, about 165 employees will be affected by the…
Clinical trial results released by Wave Life Sciences Wednesday appear to provide early validation for the company’s newest drugmaking technology as well as a burgeoning field of genetic medicine, RNA editing. The data are from just two patients, the first treated in a Wave study of the biotechnology firm’s medicine for an inherited lung and…
Dive Brief: The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo….
Dive Brief: Sales of Johnson & Johnson’s cancer therapy Carvykti and immune disease drug Tremfya grew strongly during the third quarter, the pharmaceutical company reported Tuesday, as new approvals helped broaden the two medicines’ market reach. The growth from Carvykti and Tremfya comes as J&J prepares for biosimilar competition to its second best-selling drug, Stelara,…
