Medicine

Dive Brief: European life sciences venture firm Forbion on Tuesday said it has raised 2 billion euros, or more than $2.2 billion, for two of its newest investment funds. Forbion Growth Opportunities III pulled in 1.2 billion euros, while Forbion Ventures VII secured 890 million euros. Both funds exceeded their original targets, bringing the firm’s…

Danish drugmaker Lundbeck has agreed to spend $2.6 billion acquiring a young biotechnology company with an experimental brain medicine that could become a blockbuster product. The acquisition, announced Monday, has Lundbeck paying $60 in cash for each outstanding share of Longboard Pharmaceuticals, a 54% premium to the biotech’s stock price Friday. The companies expect their…

The Food and Drug Administration has temporarily deflected a lawsuit alleging it violated federal law by removing Eli Lilly’s obesity and diabetes drugs Zepbound and Mounjaro from an agency shortage list. But in the process, the regulator agreed to evaluate objections from the companies selling compounded copycats of Lilly’s fast-selling medicines. A ruling issued Friday…

An effective launch sets the stage for a new drug’s long-term success. It shapes provider and patient perceptions, drives medication starts and refills and fuels brand traction. After investing significant time and resources to develop and commercialize a drug, manufacturers can’t afford launch missteps.  As the 2024 Patient Services Report illustrates, it’s critical to select a…

The number of medical devices with artificial intelligence technology has risen sharply in the past decade.  The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of submissions has spiked…

Two former Pfizer executives announced late Wednesday night that they won’t support efforts by activist investor Starboard Value to shake up the giant drugmaker. “We have decided not to be involved,” former Pfizer CEO Ian Read and former CFO Frank D’Amelio said in the statement issued by Guggenheim Securities, a longtime adviser to Pfizer on…

Dive Brief: Upstream Bio announced Thursday it priced its initial public offering, raising $255 million to fund development of an antibody drug it’s testing against several respiratory diseases. The Waltham, Massachusetts-based biotechnology company sold 15 million shares at $17 apiece, exceeding the projections it set earlier this week. Shares will begin trading on the Nasdaq stock exchange on Friday morning…

Today, a brief rundown of news from Roche and Turnstone Biologics, as well as updates from Sanofi, Pfizer and Flagship Pioneering that you may have missed. Turnstone Biologics will lay off about 60% of its workforce and trim its pipeline in a bid to focus on a cancer cell therapy program in human testing, the…

For the past year, French pharmaceutical giant Sanofi has been searching for a buyer to take control of its consumer health business. That search may now be over. On Friday, Sanofi said it’s in negotiations with the private equity firm Clayton Dubilier & Rice for the potential sale of a 50% controlling stake in the…

Dive Brief: Upstream Bio announced Thursday it priced its initial public offering, raising $255 million to fund development of an antibody drug it’s testing against several respiratory diseases. The Waltham, Massachusetts-based biotechnology company sold 15 million shares at $17 apiece, exceeding the projections it set earlier this week. Shares will begin trading on the Nasdaq stock exchange on Friday morning…

Dive Brief: UnitedHealth Group and CVS Health want Federal Trade Commission Chair Lina Khan and two other commissioners to recuse themselves from the agency’s lawsuit against the nation’s largest pharmacy benefit managers.  In separate documents filed Tuesday, UnitedHealth-owned Optum Rx and CVS Caremark argued Khan and Commissioners Rebecca Kelly Slaughter and Alvaro Bedoya have “extensive”…

Dive Brief: Eli Lilly and Insitro said they have entered into three drug development deals that offer a “new paradigm” for collaborations between major pharmaceutical companies and smaller biotechs. Insitro, which specializes in applying machine learning to drug discovery, will get an option to license delivery technology from Lilly as part of the first two…

Biotechnology company Purespring Therapeutics has raised about $105 million to fund its development of gene therapies for diseases of the kidney. The Series B funding announced Wednesday was led by Sofinnova Partners and will support Purespring’s initiation of a Phase 1/2 study of its lead candidate for IgA nephropathy, or IgAN. Forbion, Glide Healthcare and…

Basecamp Research, a biotechnology startup focused on artificial intelligence, has raised $60 million in funding and signed a multi-year collaboration with the Broad Institute of MIT and Harvard. The London-based company said Wednesday that it will work with the lab of David Liu, a prominent gene editing researcher and biotech entrepreneur, to advance new types…

Alzheimer’s disease remains one of the world’s most indomitable illnesses, and on Tuesday it defeated yet another potential treatment in an experimental drug from Sage Therapeutics. A mid-stage clinical trial has been evaluating the drug, known as dalzanemdor or SAGE-718, in patients with mild cognitive impairment or mild dementia due to Alzheimer’s. The study enrolled…

Dive Brief: An experimental, muscle-preserving therapy from Scholar Rock succeeded in a Phase 3 trial in spinal muscular atrophy, positioning the biotechnology company to seek approvals in the U.S. and Europe early next year. A regimen of Scholar Rock’s drug, apitegromab, and a standard SMA therapy significantly improved motor function after one year versus treatment…

Dive Brief: GSK-backed ViiV Healthcare on Monday said it plans to triple the amount of its HIV prevention therapy it will make available at a not-for-profit price in low- and middle-income countries next year and in 2026. The company, which is majority owned by GSK and counts Pfizer and Shionogi as stockholders, is committing to…

In developing drugs for rare diseases, ensuring long-term patient safety is paramount. Unlike more common conditions, rare diseases present unique challenges that make creating a comprehensive safety profile for patients both critical and complex. This complexity demands a strategic approach that not only ensures patient safety but also meets regulatory requirements and market access realities. The…

Dive Brief: A major California health plan has struck a novel deal with a drug manufacturer for a cheaper version of Humira, entirely cutting out pharmacy benefit managers — controversial middlemen in the drug supply chain that typically control access to medications. As a result of the deal, Blue Shield of California will purchase a…

Cassava Sciences has faced intense regulatory scrutiny over alleged clinical impropriety in studies of its experimental Alzheimer’s disease drug. Most recently, Cassava agreed to pay millions of dollars to resolve corporate misconduct allegations from the Securities and Exchange Commission. Now, some experts want Cassava to get more attention from the FDA and have its clinical…

Today, a brief rundown of news from Bristol Myers Squibb and Johnson & Johnson, as well as updates from Bayer, the World Health Organization and Frazier Life Sciences that you may have missed. Bristol Myers Squibb said Thursday its cancer immunotherapy Opdivo won expanded use in early stage non-small cell lung cancer, gaining Food and…

Over the past decade, the medicine Enjaymo has been passed around no less than five times by developers large and small. Now it’s trading hands again, through a deal announced Friday. Sanofi is selling global rights to Enjaymo to the Italy-based drugmaker Recordati, in exchange for an upfront payment of $825 million. And if the…

Dive Brief: Gene editing company Editas Medicines has sold off license fees and future payments it’s owed under an agreement with Vertex Pharmaceuticals to DRI Healthcare Trust for $57 million upfront. Last year, Vertex paid Editas $50 million for rights to its CRISPR technology, promising another $50 million in future payments as well as annual…

Dive Brief: Shortages affecting the availability of Eli Lilly’s top-selling diabetes and weight-loss drugs have now been resolved, the Food and Drug Administration said Wednesday. Lilly has assured regulators that product availability and manufacturing capacity is enough to meet both current and projected demand in the U.S., the FDA said. The drugs, sold as Mounjaro…

The U.S. government is fine-tuning the rules for how it will negotiate drug prices within Medicare when the second round of talks with drugmakers begins early next year. Specifically, officials at the Centers for Medicare and Medicaid Services plan to offer manufacturers earlier meetings to discuss pricing offers, according to final guidance the agency released…

Dive Brief: Eli Lilly on Wednesday announced plans to spend $4.5 billion on a new facility that will use advancements in technology for research and manufacturing. Dubbed the Lilly Medicine Foundry, the new site will be located in the “LEAP Research and Innovation District” in Lebanon, Indiana. The latest infusion of cash brings Lilly’s investment…

Dive Brief: Gilead on Wednesday said it signed royalty-free licensing agreements with six generic drugmakers to produce and sell its HIV drug lenacapavir in countries with high incidence of the disease but limited resources. Announcement of the licensing deals comes ahead of Gilead’s plans to ask regulators for approval of lenacapavir as a preventive treatment….

Today, a brief rundown of news from IGM Biosciences and Metsera, as well as updates from Gritstone Bio, UCB and Moderna that you may have missed. IGM Biosciences is shifting its focus to autoimmune disease research, the company said Monday. IGM’s most advanced candidate had been a cancer drug in testing against against colorectal tumors….

With rare exceptions, biotechnology and pharmaceutical companies validate their business plans through clinical trials, results from which are often presented and dissected at medical conferences throughout the year. These are the forums where executives get to showcase the “proof of concept” they so frequently talk about. Some meetings tend to spotlight the early human research…

Boston-based Aktis Oncology has raised $175 million in fresh funding to advance its pipeline of radiopharmaceutical medicines for cancer. The Series B round, announced by Aktis Monday, was led by RA Capital Management and co-led by RTW Investments and Janus Henderson Investors. It also drew in pharmas that had previously backed Aktis, namely Bristol Myers…

Dive Brief: Roche on Monday agreed to pay $850 million to acquire two experimental breast cancer drugs being developed by China-based biotechnology startup Regor Therapeutics. The deal hands Roche two medicines that Regor, in a statement, described as “next-generation” versions of the CDK inhibitors widely used to treat certain breast cancers. One prospect is in…

Precision oncology continues to be one of the fastest-growing markets within pharmaceuticals. Valued at $130 Billion in 2023, the global market is expected to grow at a CAGR of nearly 9% between 2023 and 2035 to a projected $364 Billion, reports Roots Analysis. While the field presents a tremendous opportunity, it also comes with unique challenges…

2Seventy bio, the cancer-focused drugmaker spun out of Bluebird bio, has decided to stop enrolling a key study that’s been evaluating its multiple myeloma therapy Abecma earlier in the treatment process. The decision announced Wednesday was made, in part, to help ensure 2Seventy breaks even financially next year. The biotechnology company expects ending the trial…

Arch Venture Partners, a prominent creator of biotechnology startups, has raised more than $3 billion for its 13th fund, the firm announced Thursday.  The fundraise comes only two years after Arch secured a similar-sized haul that, at the time, was its largest to date. As it has in the past, the 38-year-old firm intends to…

Dive Brief: Two House Democrats have called for an investigation of former Food and Drug Administration device director Jeff Shuren after The New York Times reported on potential conflicts of interest. Reps. Anna Eshoo, D-Calif., and Rosa DeLauro, D-Conn., sent a letter to the Office of Inspector General of the Department of Health and Human…

The Food and Drug Administration on Friday approved Regeneron Pharmaceuticals and Sanofi’s inflammatory disease drug Dupixent for a common lung condition. The decision could significantly expand use of what is already one of the industry’s best-selling medicines. Dupixent is now cleared for use as an add-on maintenance treatment for adults with a certain kind of…

Today, a brief rundown of news from J&J and the FDA, as well as updates from Sage Therapeutics, Roche and Enanta Pharmaceuticals that you may have missed. New data from two trials testing Johnson & Johnson’s multiple myeloma drug Talvey could help the company make the case for its use in combination with other medicines….

For the first time in more than two decades, a completely new form of antipsychotic medication will be available in the U.S. following an approval Thursday by the Food and Drug Administration. While momentous, the approval may also put a renewed spotlight on an enduring defect of the American healthcare system. An effective medicine is…

Dive Brief: Pfizer is pulling the sickle cell disease drug Oxbryta off the market and ending clinical trials of the medicine around the world due to safety concerns. Clinical data “now indicates that the overall benefit of Oxbryta no longer outweighs the risk,” Pfizer said Wednesday. The company said data show an imbalance of deaths…

BioAge Labs has raised $198 million in an initial public offering, the company announced Wednesday, capitalizing on intense investor interest in drugs that can promote weight loss.   BioAge, which is evaluating a medicine that’s meant to boost the effects of popular obesity drugs known as GLP-1 agonists, sold 11 million shares at $18 apiece…

Genespire, an Italy-based biotechnology startup making “off-the-shelf” gene therapies treatment for rare pediatric genetic conditions, has raised €46.6 million euros, or about $52 million, in a Series B round announced Wednesday. The capital infusion will help Genespire advance a method of delivering lentiviral gene therapies in a more convenient way. Typically, lentiviruses — viral carriers…

Novo Nordisk’s top executive vowed to reopen price negotiations with insurers covering the company’s obesity and diabetes drugs at a congressional hearing on Tuesday in which lawmakers pressed Novo to lower the cost of the fast-selling medicines. At the hearing, Novo CEO Lars Fruergaard Jørgensen said the company would consider new talks with insurers about…

Struggling gene therapy developer Bluebird bio is again cutting costs, announcing Tuesday a plan to lay off about a quarter of its workforce to reduce spending. In a statement, Bluebird said it turned to layoffs as part of a broader plan to break even financially on a quarterly basis in the second half of next…

After more than two decades of work, partners Biogen and UCB say they finally have positive results from a late-stage clinical trial evaluating one of their experimental drugs for lupus. The companies didn’t release any data, but said the drug, when paired with the current standard of care, was significantly better than a placebo at…

Dive Brief: An experimental medicine from AstraZeneca and Daiichi Sankyo failed to help people with a common form of breast cancer live longer than those who received standard chemotherapy in a Phase 3 trial, the companies said Monday, raising more questions about the therapy’s approval prospects. AstraZeneca and Daiichi previously said that the treatment, a…

Dive Brief: Vicebio, a London-based biotechnology startup, has raised $100 million in Series B financing to continue developing a technology it claims has the potential to produce potent vaccines that are easy to manufacture.  The Series B round announced Monday was led by new backer TCGX and involved Goldman Sachs Alternatives, Avoro Ventures and founding…

A new company born out of research done by top Harvard genetic scientist George Church is promising to “revolutionize cell therapy.” The company, GC Therapeutics, announced its launch Thursday with $75 million in financing from investors including Cormorant Asset Management and Mubadala Capital. Its board and list of advisers includes John Maraganore, the founding CEO…

Dive Brief: 23andMe’s independent board directors resigned on Tuesday amid uncertainty about the DNA testing company’s future. In a letter to CEO Anne Wojcicki, the seven board members said they had not received a revised offer for the company that was in the best interests of non-affiliated shareholders — and they did not expect one…

European drug regulators have officially turned back a first-of-its-kind eye drug from Apellis Pharmaceuticals despite multiple attempts by the company to have the evidence supporting the medicine’s purported benefits reevaluated.  Apellis on Friday said a committee advising the European Medicines Agency has confirmed a June recommendation to reject an application for pegcetacoplan, a drug sold…

Today, a brief rundown of news from Sanofi and Novo Nordisk, as well as updates from The Lasker Foundation, Edgewise Therapeutics and Vanda Pharmaceuticals that you may have missed. Novo Nordisk shares fell 6% in Friday trading today after reporting mixed study results from a Phase 2 trial of a weight-loss drug it acquired in a…

Dive Brief: The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs. The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin to bring in larger…

Dive Brief: Roche’s antiviral drug Xofluza reduced influenza transmission among household contacts in a large Phase 3 study, the company said Wednesday. Treatment with a single dose of Xofluza within 48 hours of symptom onset lowered the likelihood an infected person passed on the virus to other individuals within the same household. Roche didn’t disclose…

Dive Brief: People with a common form of macular degeneration needed far fewer injections to manage their eye condition following treatment with an experimental gene therapy developed by 4D Molecular Therapeutics, the company said Wednesday. Study investigators found 4D Molecular’s therapy reduced patients’ treatment burden by between 83% and 98%, depending on the severity of…

Dive Brief: Organon has agreed to buy Roivant’s dermatology subsidiary Dermavant for $175 million upfront plus more than $1 billion in potential additional payments if certain milestones are hit. With the acquisition, Organon will gain Dermavant’s cream called Vtama, which was approved in 2022 to treat plaque psoriasis. The medicine is also awaiting action from…

Today, a brief rundown of news from Novartis and GSK, as well as updates from Omega Funds, Serán Bioscience and Boehringer Ingelheim that you may have missed. The Food and Drug Administration approved expanded use of Novartis’ breast cancer drug Kisqali, permitting its use in women in early stages of hormone-sensitive, HER-negative disease following surgery…

BioMarin Pharmaceutical, after months of layoffs, spending cuts and research reorganizations, has staked its future on the continued success of its approved drug for a common cause of dwarfism. But the San Rafael, California-based biotechnology company could have a new competitor that might complicate those well-laid plans. On Monday, Ascendis Pharma released summary results from a…

Dive Brief: An antibody-drug conjugate developed by Daiichi Sankyo and Merck & Co. met the main goal of a Phase 3 lung cancer trial, delaying tumor progression in people whose disease has a specific mutation by longer than chemotherapy, the companies said Tuesday. The companies didn’t release detailed data from the trial, which tested patritumab…

Sanofi said it’s ready to meet demand for its RSV shot Beyfortus this year, announcing Monday the clearance by the Food and Drug Administration of a new manufacturing line. The French pharmaceutical company and partner AstraZeneca are shipping 50 milligram and 100 milligram doses of the antibody drug to private healthcare providers and the U.S….

Over the weekend at the European Society for Medical Oncology’s annual meeting in Barcelona, cancer researchers unveiled results from scores of important clinical trials. You can read full stories from us on iTeos Therapeutics’ much-anticipated TIGIT drug data and Bristol Myers Squibb’s 10-year data from Opdivo and Yervoy. Other notable trial readouts we’ve summarized in…

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: Moderna will cut R&D spending by 20% and trim its pipeline as part of a strategic overhaul that will shift its research focus and put more resources into products that are either nearing approvals or…

A decade of follow-up on people with melanoma who were treated with cancer immunotherapy shows how two drugs have dramatically reshaped the outlook for the deadly skin cancer. New data show people with advanced melanoma and treated with Bristol Myers Squibb’s Opdivo and Yervoy in a clinical trial lived a median of six years following…

Vironexis Biotherapeutics emerged from stealth with plans to start what it claims will be the first-ever clinical trial testing a cancer immunotherapy delivered with the help of an adeno-associated virus, or AAV.  The startup’s technology combines an AAV — a common gene therapy delivery tool — with an immunotherapy approach now widely used in oncology….

Small biotechnology company iTeos Therapeutics could succeed where larger drugmakers have fallen short, should study results it presented Saturday at a cancer research conference hold up in further testing. The results, from a mid-stage clinical trial, show that adding iTeos’ drug to an approved GSK immunotherapy shrank lung tumors in roughly twice as many people…

Today, a brief rundown of news from Roche and Gilead Sciences, as well as updates from Eli Lilly, Biogen and GSK that you may have missed. The Food and Drug Administration approved a version of Roche’s cancer immunotherapy Tecentriq that can be administered through an injection just under the skin, the company said Friday. The…

Months after winning approval of a new vaccine for respiratory syncytial virus, Moderna is acknowledging that wresting market share from its two competitors may be more difficult than it thought. Moderna’s RSV shot secured Food and Drug Administration clearance for older adults in late May, joining vaccines from GSK and Pfizer on the U.S. market….

Three drug startups collectively raised more than $700 million in initial public offerings Thursday, a flurry of activity after a largely fallow summer in which few biotechnology companies made the jump to public markets. Cancer biotech Bicara Therapeutics secured $315 million in the third-largest IPO of the year, according to BioPharma Dive data. Autoimmune drug developer…

Dive Brief: An experimental drug Fulcrum Therapeutics has been testing against a type of muscular dystrophy failed a Phase 3 trial, prompting the biotechnology company to suspend development of the program. Despite claiming to see positive signs in a previous test, Fulcrum said the drug, dubbed losmapimod, couldn’t replicate those results. Losmapimod missed its main…

Dive Brief: Sanofi and Regeneron plan to make a second attempt at expanding use of their blockbuster drug Dupixent to people with a chronic skin condition that causes hives. The Food and Drug Administration rejected the companies’ initial application in chronic spontaneous urticaria, or CSU, last year, requesting additional efficacy data to support the new…

Dive Brief: BridgeBio Pharma plans to trim its spending on gene therapy research by more than $50 million after early-stage study results for one of its experimental therapies failed to meet the company’s threshold for additional investment. Disclosed by BridgeBio Tuesday afternoon, the data showed treatment with the company’s BBP-631 therapy led to increased production…

Early results from a small study have convinced Centessa Pharmaceuticals to “rapidly advance” an experimental drug it believes could be a useful treatment for diseases hallmarked by excessive sleepiness. The study enrolled healthy volunteers who hadn’t gotten enough sleep for a short period of time. It then assessed three doses of Centessa’s drug, one of…

Bain Capital Life Sciences said Tuesday it has secured about $3 billion for its fourth fund, bringing the private investment firm’s total haul since its 2016 inception to $6.7 billion. Bain Capital said the new fund includes $2.5 billion of outside commitments from new and existing investors, with the remainder coming from its partners, employees…

Dive Brief: An experimental weight loss pill developed by biotechnology company Terns Pharmaceuticals helped some people with obesity lose more than 5% of their body weight in a small Phase 1 trial, supporting plans to move the drug into mid-stage testing next year, the company said Monday. Trial volunteers who received the highest tested dose…

Dive Brief: An experimental drug regimen for breast cancer being developed by Relay Therapeutics delayed tumor growth by a median of about nine months in a small clinical trial, results that were promising enough to propel the biotechnology company’s shares higher by more than 50% Monday. When added to an older hormonal therapy, Relay’s drug…

Nine years ago, Lisa Haines got news no one wants to hear. Her doctors said her lung cancer, which chemotherapy had earlier arrested, was growing again. The Massachusetts resident began planning for family events she thought would be her last, like her son’s wedding and a Thanksgiving trip. Her doctor didn’t give up, however. She…

An experimental medicine from a small biotechnology company cut the risk of lung cancer progression in half when tested against the world’s most dominant immunotherapy in a clinical trial, according to study data presented Sunday at a major medical meeting. The results come from a Phase 3 trial pitting a drug from biotech Summit Therapeutics…

Dive Brief: Novartis said Wednesday it’s expanding a manufacturing site in Indianapolis and building a new plant in California in anticipation of growing demand for radiopharmaceutical therapies to treat cancer. The company said it has already broken ground on a new facility at its Indianapolis site, where Novartis plans to produce the radioisotopes that are…

Dive Brief: GSK on Friday said its Nucala medicine succeeded in a Phase 3 study of patients with chronic obstructive pulmonary disease, offering the British drugmaker another shot at an expanded approval for the drug The trial, known as MATINEE, included COPD patients suffering from chronic bronchitis and/or emphysema who were already taking inhaled therapies…

Today, a brief rundown of news from OrsoBio, as well as updates from Boehringer Ingelheim, Novartis and Vaxcyte that you may have missed. OrsoBio, an obesity-focused startup backed by Eli Lilly, has raised $67 million in a Series B funding round, the company announced Friday. The cash will help advance a portfolio of weight loss…

Dive Brief: A Delaware judge ruled Wednesday that Johnson & Johnson must pay Auris Health’s former investors more than $1 billion in damages after violating a 2019 merger agreement between the healthcare giant and surgical robotics firm. J&J did not provide Auris with resources to accomplish regulatory milestones — tied to more than $1 billion…

The CEO of Lykos Therapeutics will step down after the company’s efforts to win a milestone approval for MDMA as a therapy aid were rejected by the Food and Drug Administration last month. Amy Emerson, who has led Lykos since its formation 10 years ago, will continue as an adviser and observer to the board…

Eli Lilly on Thursday revealed new data that could help it catch rival Novo Nordisk in a race between the two large drugmakers to develop a once-weekly insulin shot. The Indianapolis-based drugmaker said that, in a pair of Phase 3 trials, its experimental shot controlled blood sugar as well as two commonly used daily insulins…

BioMarin Pharmaceutical has brought eight rare disease drugs to market over the past 25 years, a record few companies in the biotechnology industry can match. But recently the company’s momentum has stalled and, over the past nine months, it has shed jobs, cut spending and shelved research projects in a major bid to revive its…

Today, a brief rundown of news from Biogen, as well as updates from Dyne Therapeutics, Denali Therapeutics and Novo Nordisk that you may have missed. A higher dose regimen of Biogen’s drug Spinraza met the goal of a Phase 2/3 study testing it in previously untreated infants with spinal muscular atrophy, showing improvements in motor…

Dive Brief: Shares in vaccine developer Vaxcyte soared by over 35% Tuesday after the company unveiled results from a large study testing its experimental pneumococcal shot that analysts described as a best-case scenario. Data from the Phase 1/2 trial showed Vaxcyte’s vaccine matched the effectiveness of Pfizer’s market-leading Prevnar 20 in protecting against 20 common…

Regulators in the U.S. and Europe recently determined that a popular group of drugs for weight loss and diabetes don’t heighten the risk of suicide. New data published in the Journal of the American Medical Association on Tuesday appear to back up those assessments, though researchers cautioned that there’s still more work to be done….

The psychedelic drug field hit a setback this month when the Food and Drug Administration rejected Lykos Therapeutics’ application for approval of an MDMA-assisted therapy. The rejection was not entirely unexpected, after advisers to the FDA had recommended against approval for several reasons, including concerns over drug abuse, alleged sexual misconduct during testing and Lykos’…

The chair of the powerful House Committee on Oversight and Accountability is threatening the leaders of the three largest pharmacy benefit managers in the country with steep fines — or jail time — for allegedly lying in a recent congressional hearing. Chairman James Comer, R-Ky., sent letters Wednesday to Patrick Conway, the CEO of UnitedHealth’s…

Investment in developers of cell and gene therapies has nosedived this year, a sharp drop-off that investors and analysts say reflect manufacturing and drug delivery challenges at a time when biotechnology companies with clear development paths are increasingly favored. So far this year, makers of cell and gene therapies have raised half of a billion…

Johnson & Johnson is asking the Food and Drug Administration to approve a new medicine the company believes can eventually be used to treat many diseases. The initial submission covers use of the drug, called nipocalimab, in patients with generalized myasthenia gravis, J&J said Thursday. The condition causes a patient’s immune system to attack proteins…

Two months ago, Alnylam Pharmaceuticals revealed that a medicine it’s been developing for people with a deadly heart condition succeeded in a closely watched clinical trial. On Friday, the biotechnology company is presenting fuller study findings its leaders claim are evidence the drug should become the new standard of care for the disease, called transthyretin…

Today, a brief rundown of news from Novo Nordisk and Ventyx Biosciences, as well as updates from Novartis and Pfizer that you may have missed. A pooled analysis of data from four trials of Novo Nordisk’s obesity drug semaglutide found treatment reduced the risk of cardiovascular death or worsening heart failure by 31% compared to…

Dive Brief: Merck & Co.’s drug Keytruda failed to help people with cancer in two clinical trials, both using the immunotherapy as an add-on to other types of treatment for early-stage lung and skin cancer, the comapny said Thursday. Both trials were stopped early following the recommendation of independent data analysts, who said the addition of…

Amid a major corporate shakeout, BioMarin Pharmaceutical intends to lay off over 200 staff, according to a regulatory filing made Wednesday by the rare disease drug developer. In the notice, Biomarin said it has “committed to a plan” to reduce its global workforce by approximately 225 employees. The move is connected to the company’s ongoing…

Bayer and biotechnology company NextRNA Therapeutics on Wednesday said they have partnered to develop a new kind of small molecule drug for cancer, agreeing to a collaboration deal that could be worth more than half of a billion dollars. The two companies will use NextRNA’s technology to advance two small molecule drugs that target cancers…

Neurocrine Biosciences on Wednesday reported results from a schizophrenia drug study that, despite one bright spot, mostly disappointed investors. The study tested four doses of the drug, which is one of Neurocrine’s most advanced and closely watched research programs, in adults with schizophrenia. After six weeks of treatment, participants on the lowest dose experienced a…

Dive Brief: Eli Lilly is now distributing a single-dose vial form of its popular weight loss medicine Zepbound that it says people with a valid prescription can obtain for a cash price that’s 50% less than the current cost of other GLP-1 drugs for obesity. The single-dose vials are available through Lilly’s online service LillyDirect…

Pfizer on Tuesday launched a direct-to-consumer service it claims will help people schedule telehealth appointments, fill prescriptions and access savings programs for the company’s migraine, COVID-19 or influenza medicines. Dubbed PfizerForAll, the online service will provide resources for people looking to obtain treatment for migraine, COVID or the flu, or to schedule vaccinations for diseases…

Genetic medicines startup Tome Biosciences is letting go of much of its staff after hitting setbacks following a buzzy launch last December. In a Massachusetts state regulatory notice, the biotechnology company said 131 employees would lose their jobs by November. The notice follows a report by Stat last week that the company was struggling financially….

Dive Brief: The European Commission has authorized Regeneron’s dual-acting drug odronextamab to treat two types of lymphoma, clearing it for use in 27 European Union countries, the company said Monday. The drug, which will be sold as Ordspono, can be used following two or more lines of systemic therapy, including cell therapies. In Phase 2…

Large employers are bracing for a substantial increase in healthcare costs next year, driven by higher spending on medicines like the popular GLP-1 drugs for obesity, according to the Business Group on Health’s annual survey of its members. The predicted 7.8% spending increase is the highest projection in more than 15 years, per the group,…

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. BioMarin is recasting some of its executive team, announcing Wednesday the appointments of two pharmaceutical industry veterans to direct the company’s dealmaking and research and development operations. Effective Sept. 30, Greg Friberg will assume the role of chief…

Chinook Therapeutics ranks among Versant Ventures’ most successful biotechnology bets. The kidney disease drug developer, which Versant founded in 2019 and went public one year later, was bought by Novartis last summer for $3.5 billion. The acquisition gave Novartis a drug that, soon after the deal, succeeded in Phase 3 testing for a condition known…

Leqembi’s benefits are “too small to justify the significant cost to the NHS,” said the head of a UK agency in charge of determining medicine reimbursement.

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 from the Food and Drug Administration, as well as updates from Tome Biosciences, Sky Bioscience and Ambrosia Biosciences that you may have missed. The Food and Drug Administration will convene a…

Dive Brief: A pair of U.S. biotechnology companies on Thursday filed plans for initial public offerings, testing a market that’s proven challenging to crack for young drug startups lacking clinical data or without the backing of a major investor syndicate. One of the two, Zenas BioPharma, is developing a bifunctional monoclonal antibody called obexelimab for…

Dive Brief: The Food and Drug Administration on Thursday cleared new versions of Pfizer’s and Moderna’s COVID-19 vaccines that are designed to better match the coronavirus strains currently circulating in the U.S.  Both of Pfizer’s and Moderna’s reformulated shots target the KP.2 virus strain, which was dominant in the spring and belongs to the broader…

The Food and Drug Administration is defending the record of Jeff Shuren, former director of the agency’s medical device center, after The New York Times reported on how his role intersected with his wife’s work as legal counsel for medtech companies. Shuren’s wife, Allison Shuren, is co-chair of the life sciences and healthcare regulatory practice…

BridgeBio Pharma has transferred several preclinical and early clinical-stage drugs to a new company, GondolaBio, that’s drawn $300 million in promised investment from a syndicate of blue-chip life sciences investors. Viking Global Investors, Patient Square Capital and Frazier Life Sciences are among the investors backing GondolaBio, according to a Wednesday securities filing from BridgeBio. Also…

Dive Brief: After warning investors earlier this month of a possible delay, Regeneron Pharmaceuticals on Tuesday confirmed that U.S. regulators will not approve its experimental multiple myeloma drug at this time. The Food and Drug Administration previously identified flaws at a third-party fill/finish manufacturing facility. And while the manufacturer believes the issues have been resolved,…

Today, a brief rundown of stock sales by Avidity Biosciences and Kymera Therapeutics, as well as a new partnership between Walgreens and BARDA that you may have missed. Avidity Biosciences raised an additional $345 million by selling north of 8.4 million common shares at $41 apiece. The San Diego-based biotechnology company went public in 2020,…

Dive Brief: The Food and Drug Administration has approved a new combination drug regimen from Johnson & Johnson to treat a common type of advanced lung cancer with certain genetic mutations. J&J’s Rybrevant is now cleared for use with another drug called Lazcluze in people with previously untreated non-small cell lung cancer that’s metastasized or…

A subsidiary of Danish drugmaker Novo Nordisk is investing 1.5 billion Danish kroner, or about $220 million, to build a new factory at an existing site in Køge, a small seaside town about 25 miles southwest of Copenhagen. The facility will span some 8,000 square meters and support drug production and storage as well as…

BioNTech partner MediLink Therapeutics can resume enrollment of a Phase 1 clinical trial testing an antibody-drug conjugate in people with lung and breast cancer, BioNTech said Monday, after the Food and Drug Administration removed a partial hold related to immune-related side effects. Trial investigators will limit dosing of the drug, dubbed BNT326, to 3 milligrams…

The U.S. government on Thursday said it stands to save taxpayers $6 billion on the prices it will pay for 10 widely used prescription drugs under its new authority to leverage Medicare’s market power to reduce the cost of brand-name medicines. The prices for the drugs, which include two popular blood thinners, several diabetes treatments…

Dive Brief: Gilead Sciences has won Food and Drug Administration approval to sell Livdelzi, a new medicine for a rare liver disease known as primary biliary cholangitis. The FDA clearance covers patients who can’t tolerate a commonly used treatment called ursodeoxycholic acid or those whose disease doesn’t respond well enough to the older medicine alone….

The Biden administration struck a triumphant tone on Thursday in rolling out the first drug price cuts negotiated by Medicare, a new authority granted by the Inflation Reduction Act. But the industry and investment community’s response to the long-awaited announcement was mixed, signaling a level of uncertainty as to the law’s true impact on drugmakers…

Today, a brief rundown of news from Zealand Pharma and Bluebird Bio, as well as updates from Boundless Bio and Arrowhead Pharmaceuticals that you may have missed. Zealand Pharma plans to accelerate the development of its experimental weight loss drugs following clinical results that fueled a $1 billion equity raise, the company said Thursday. Zealand…

Dive Brief: Pfizer and BioNTech on Friday said a combination flu and COVID-19 shot they’ve been developing met one of its main goals in a Phase 3 trial but missed another, leaving the vaccine’s future in doubt.  The study tested Pfizer and BioNTech’s vaccine against separately administered, marketed COVID and flu shots in more than…

Lykos Therapeutics plans to lay off about 75% of its staff as part of a larger shake-up at the California-based company, which just last week suffered a major defeat at the hands of the Food and Drug Administration. Lykos and its founder, Rick Doblin, have for years tried to persuade regulators and the pharmaceutical industry…

The Food and Drug Administration has approved another medicine for a rare condition that arises after a bone marrow or stem cell transplant, when donor cells treat the new body they’ve been placed into as a world of foreign pathogens and start attacking its healthy tissues. The condition, known as graft-versus-host disease or GVHD, is…

Dive Brief: Grail said it will lay off about 350 employees in a restructuring that comes less than two months after the cancer blood test maker separated from Illumina. The job cuts represent 25% of its workforce as of June 30. The standalone company will reprioritize its resources to focus on the Galleri multi-cancer early…

Dive Brief: Evotec, a German drug discovery and contract development and manufacturing company, is restructuring amid a slowdown in early-stage research spending. First-half revenue and profitability “have been more challenging for the company than expected,” new CEO Christian Wojczewski said in a statement Wednesday. That’s prompted the company to build on a “priority reset” announced…

Dive Brief: Acelyrin, the biotechnology company behind the sector’s largest initial public offering last year, is shifting away from the medicine that helped it attract Wall Street investors, announcing Tuesday plans to focus instead on another drug that’s in earlier testing. Acelyrin will no longer develop its drug izokibep in the autoimmune diseases hidradenitis suppurativa…

Dive Brief: Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with prurigo nodularis, a chronic skin condition characterized by intense itch. A subcutaneous injection, Nemluvio works by blocking cellular signaling via a cytokine called IL-31. Results from two Phase 3 clinical trials showed treatment helped to…

Dive Brief: Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the shot in a late-stage study. The results came from a substudy of a Pfizer-run Phase 3 trial testing two doses of Abrysvo in adults at risk of severe lower respiratory tract disease associated with respiratory…

A day after the Food and Drug Administration rejected MDMA as a therapy aid for post-traumatic stress disorder, a scientific journal retracted three papers about the treatment, citing “unethical conduct.” Editors at Psychopharmacology said they were informed by researchers associated with the studies of protocol violations at a testing site in Canada. This is the…

Dive Brief: Eli Lilly on Tuesday raised its revenue forecast for the year by $3 billion as it reported second-quarter earnings that exceeded Wall Street’s expectations and sent shares climbing by double digits. Sales of Lilly’s drugs Mounjaro and Zepbound, which contain the same ingredient but are respectively sold for diabetes and obesity, rose sharply…

Dive Brief: Recursion and Exscientia, two artificial intelligence firms, on Thursday announced that they would combine, betting their complementary skills in technology-based drug discovery will lead to faster and better development of medicines. The new entity will keep the name Recursion, and current Recursion shareholders will end up with about 74% of it. The company…

Eli Lilly is making progress resolving the supply strains that for months have made its in-demand obesity and diabetes medicines difficult to get. However, even as shortages ease, the drugs’ availability at the pharmacy counter may remain in flux. Earlier this month, the Food and Drug Administration updated its drug shortage database to indicate that…

The recent downturn in the biotechnology sector affected startups in many ways, from the availability of financing to the types of research they pursued. A report J.P. Morgan analysts published late last month suggests yet another ripple effect: a seeming shift in the terms young drugmakers receive in partnership deals. According to the report, the…

The Food and Drug Administration has rejected a bid to get MDMA approved as a therapy aid for people with post-traumatic stress disorder, a decision that puts off a major milestone for the field of psychedelics. The verdict Friday comes at a pivotal time for this area of research, which has, after decades of dismissal…

Merck & Co. on Friday acquired an experimental drug designed to wipe out the immune system’s B cells in a deal that adds to a surge of industry interest in using so-called bispecific antibodies to treat autoimmune diseases. Per deal terms, Merck will pay Curon Biopharmaceutical, a privately held, China-based biotechnology company, $700 million upfront…

Today, a brief rundown of news from Merck & Co. and Cabaletta Bio, as well as updates from Intellia Therapeutics, Vertex Pharmaceuticals and Novartis that you may have missed. An experimental Merck & Co. drug aimed at the cancer immunotherapy target TIGIT has failed another clinical trial, the company said Thursday. Independent trial monitors advised…

Dive Brief: Treatment with an Apellis Pharmaceuticals drug appeared to benefit people with one of two uncommon kidney diseases, according to results from a late-stage clinical trial the biotechnology company disclosed Thursday. The drug, called pegcetacoplan and sold by Apellis as Empaveli for a rare blood disorder, reduced urine protein levels by 68% versus placebo…

Dive Brief: Novo Nordisk shares tumbled 7% in early trading Wednesday after the company reported lower-than-expected revenue from its blockbuster obesity franchise. Even as revenue from Wegovy and Ozempic continued to soar, the second-quarter numbers failed to reach the high expectations set by Wall Street, analysts said. Sales of the so-called GLP-1 obesity drugs were…

Today, a brief rundown of news from Amgen and Servier, as well as updates from Merck & Co., Precigen and Sofinnova Investments that you may have missed. Speaking on a conference call Tuesday, executives at Amgen again fielded a long slate of analyst questions on the company’s obesity drug development. But unlike in May, they…

Despite decades of research and many millions of dollars invested, Roche still has yet to develop a drug that works against Alzheimer’s disease. The Swiss pharmaceutical giant hasn’t given up, though, and on Tuesday announced a new deal that offers another shot at its enduring goal. Through its Genentech research arm, Roche has licensed technology…

Venture firm Apple Tree Partners has invested $55 million in a new biotechnology company developing antiviral treatments capable of working across families of viruses. The company, called Red Queen Therapeutics, envisions its technology as a foundation for antiviral drugs against infectious pathogens like COVID-19, influenza and respiratory syncytial virus. Already, it has advanced a COVID…

Bristol Myers Squibb has returned an experimental cancer immunotherapy to Agenus, ending an alliance that could’ve been worth more than $1 billion to the Lexington, Massachusetts-based biotechnology company. In a regulatory filing Friday, Agenus revealed a licensing deal the two forged in 2021 was terminated by Bristol Myers as part of the pharmaceutical firm’s “strategic…

Dive Brief: All doses of tirzepatide, the drug Eli Lilly sells as Zepbound for obesity and Mounjaro for diabetes, are now available in the U.S. after months of shortages made the in-demand medicine hard to obtain. Two dose strengths of Zepbound and another two of Mounjaro had been listed in short supply on a database…

Dive Brief: Cigna’s chief executive is pledging to be more aggressive in defending its pharmacy benefit manager amid mounting public criticism of the drug middlemen — and as its PBM, Express Scripts, continues to drive soaring revenue for the insurance giant. That includes heavier lobbying in Washington, sponsoring more research into the value of PBMs…

Shares of Moderna fell nearly 20% on Thursday after the company lowered its 2024 financial forecasts amid slowing sales and growing competition for its vaccines.  Alongside its second-quarter earnings report, Moderna cut its projected product sales outlook this year from $4 billion to an expected $3 billion to $3.5 billion. The biotechnology company cited multiple…

Eli Lilly’s tirzepatide, the in-demand drug sold as Zepbound for weight loss, has for the first time been shown in late-stage testing to provide a cardiovascular benefit, too. Summary results from a Phase 3 study showed that treatment with tirzepatide reduced the risk of death or serious complications from a form of heart failure by…

Prominent gene therapy researcher Jim Wilson will depart the University of Pennsylvania, where he led one of the field’s largest and most influential academic groups, to found two new private companies. The new companies, called Gemma Biotherapeutics and Franklin Biolabs, will be formed from parts of the university’s gene therapy program that are being spun…

Today, a brief rundown of news from Vir Biotechnology and Vertex Pharmaceuticals, as well as updates from Neurocrine Biosciences, Alnylam Pharmaceuticals and venBio that you may have missed. Vir Biotechnology is cutting one-quarter of its workforce in a pivot away from infectious disease research. The company, which rose to prominence with its coronavirus antibody work…

The Food and Drug Administration on Thursday approved a new type of cellular medicine, clearing a therapy developed by the biotechnology company Adaptimmune for a rare soft tissue cancer called synovial sarcoma. The agency granted Adaptimmune’s therapy, formerly known as afami-cel and to be sold as Tecelra, an accelerated approval for use in some people…

Dive Brief: Gene therapy developer UniQure will shrink its workforce by 65%, cutting 300 roles across the company alongside the previously announced sale of its Lexington, Massachusetts, manufacturing facility. Reporting second quarter earnings Thursday, the biotechnology company said the layoffs would reduce its cash burn by 40%, or $75 million, per year. UniQure expects to…

After a slow start, the launch of Biogen’s prized drug for Alzheimer’s disease is picking up, which has given company leadership more confidence that it can both drive growth and compete with a rival medicine from Eli Lilly. Sales of Biogen’s drug, Leqembi, were $40 million between April and June, more than double the total…

Dive Brief: GSK on Wednesday lowered its forecast for vaccine sales this year, citing inventory changes and shifting retail prioritization in the U.S. for its shingles shot Shingrix. The British pharmaceutical company now expect sales from its vaccines division to increase by low to mid-single digit percentages, down from the high single digit to low…

Today, a brief rundown of news from Vertex Pharmaceuticals and Merck & Co. as well as updates from Fibrogen, Intellia Therapeutics and Biogen that you may have missed. The Food and Drug Administration has agreed to a speedy review of Vertex Pharmaceuticals’ closely watched pain tablet. An approval decision should come by Jan. 30. The…

Pfizer missed its first chance at following Novo Nordisk and Eli Lilly into the fast-growing market for GLP-1 obesity drugs. CEO Albert Bourla is advising investors not to count it out too quickly the second time. On Tuesday, as the company reported second quarter earnings, Bourla told analysts on a conference call he thinks Pfizer…

Dive Brief: Incyte is cutting down its pipeline of experimental cancer drugs, announcing Tuesday that it will no longer invest in five immunotherapies it’s been testing in early clinical trials. Among the discontinued programs are two so-called checkpoint inhibitors targeting a protein known as PD-L1. Unlike similar drugs already on the market that are injected…

After a dramatic post-pandemic downturn, a sense of stabilization has returned to biotech, and more healthcare professionals feel optimistic about the market’s recovery this year, according to a March Global Data survey. But bruises from the recent roller coaster ride remain. Following an influx of capital into biotech in 2021, many overvalued companies failed to…

Dive Brief: An experimental heart drug from biotechnology company NewAmsterdam Pharma met its main goal in the first of several Phase 3 trials, but the results fell short of investor and analyst expectations. In the trial, people with an inherited condition called heterozygous familial hypercholesterolemia who received the drug alongside other medicines saw their levels…

Dive Brief: An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year. The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal…

Viking Therapeutics shares soared by more than 30% early Thursday after the company told investors it’s moving an experimental obesity drug into Phase 3 testing earlier than expected and exploring more convenient dosing. The medicine, dubbed VK2735, has already shown promising results in a Phase 2 trial released in February. In that study, patients lost…

A key regulatory committee that influences whether new drugs enter the European market has voted against Leqembi, Eisai and Biogen’s prized medicine for Alzheimer’s disease. During a meeting this week, the European Medicines Agency committee concluded the medicine’s safety risks outweigh its possible benefits. Of particular concern, according to the regulators, is the “frequent occurrence”…

Today, a brief rundown of news from AbbVie and AstraZeneca as well as updates from Glycomimetics, Cue Biopharma and Confo Therapeutics that you may have missed. AbbVie on Thursday reported second quarter results indicating it is weathering growing biosimilar competition& to its flagship autoimmune disease drug Humira. According to analysts with the investment bank Piper…

Bristol Myers Squibb on Friday raised its forecast for revenue and profit per share this year after a second quarter in which sales of its older products and new drugs surpassed analyst expectations. The “beat and raise” followed similarly strong earnings reports this week from AstraZeneca, Roche, Sanofi and AbbVie, all of which upped either…

Shares of French pharmaceutical giant Sanofi ticked up Thursday morning with the release of an earnings report that beat Wall Street expectations. Sanofi recorded a little over 10.7 billion euros, or $9.9 billion, in net sales from April through June, a nearly 8% increase from the same three-month period a year prior. Earnings per share…

Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss pharmaceutical giant spent much of its latest quarterly earnings call fielding questions about a pair of experimental weight loss medicines that have fast become important to its future growth. Roche last year acquired those medicines…

Dive Brief: Sen. Elizabeth Warren, D-Mass., introduced legislation that would reverse the Supreme Court’s recent ruling on the Chevron doctrine, according to a Tuesday press release. The Stop Corporate Capture Act, a joint effort by Warren, nine other Democratic senators and Sen. Bernie Sanders, I-Vt., would codify the Chevron doctrine, which required federal courts to…

In 2020, Biogen wagered more than $1 billion on two experimental drugs developed in the labs of Sage Therapeutics, a fellow Cambridge, Massachusetts-based biotechnology company. Almost four years later, one of those drugs has hit a setback from which it may not recover. On Wednesday, Biogen and Sage said the drug, known SAGE-324, flunked a…

San Diego biotechnology company Autobahn Therapeutics on Wednesday said it raised $100 million to advance an experimental mood disorder medicine into mid-stage testing. The company, which launched in 2020, is developing the drug for major depressive disorder and bipolar disorder depression. Called ABX-002, the drug works in a somewhat similar fashion to Madrigal Pharmaceuticals’ Rezdiffra,…

Dive Brief: An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday. In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy…

Ionis Pharmaceuticals plans to push one of its rare disease drugs into late-stage testing now that a smaller trial has delivered positive results. The trial focused on Angelman syndrome, an uncommon genetic disorder that causes severe functional and learning disabilities. It evaluated three doses of Ionis’ drug, known as ION582, across 51 participants. According to…

The U.S. government will not give Bluebird bio a green light to offer fertility support to federally insured people undergoing treatment with the biotechnology company’s gene therapy Zynteglo. In a “negative opinion” issued Monday, the Department of Health and Human Services’ inspector general indicated that Bluebird’s proposed support, which would provide up to $22,500 to…

Recent advancements in immune checkpoint inhibitors (ICIs) targeting PD-1 or CTLA4 have shown significant success in treating various advanced cancers and tumor types. However, a substantial number of patients fail to respond to treatment, and currently there are no consensus biomarkers predictive of response¹. In addition, the wide variety of inhibitors have different responses and…

Dive Brief: Gilead chief medical officer Merdad Parsey will step down from his role and leave the biotechnology company early next year, Gilead said in a statement Wednesday. The planned departure of Parsey, who has served as Gilead’s top doctor since 2019, will be a significant change for the company’s drug development leadership. The announcement…

Today, a brief rundown of news from Caribou Sciences and Relay Therapeutics as well as updates from Corden Pharma, Celldex Therapeutics, and Beam Therapeutics that you may have missed. Caribou Biosciences is laying off staff one month after a clinical setback sent its shares tumbling. In a regulatory filing Tuesday, the company said it has…

Dive Brief: A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday. The data comes two months after the Swiss drugmaker…

Today, a brief rundown of news from Morphic Holding as well as updates from Novartis, the Parker Institute and Agenus that you may have missed. No company other than Eli Lilly made a bid for Morphic Holding during several months of discussions that led to the July 8 agreement for Lilly to buy the immune…

Cybersecurity firm CrowdStrike triggered a massive IT outage on Friday, disrupting businesses, including healthcare, after issuing what was supposed to be a routine software update. The firm attempted to update its Falcon Sensor product, which protects data encrypted on the cloud from cyberattacks. However, there was a bug during deployment, with some Microsoft users experiencing a critical “blue…

Boehringer Ingelheim will sell an unbranded version of its Humira biosimilar at a 92% discount to the list price of AbbVie drug for people who pay cash at pharmacies through the GoodRx price comparison platform, the companies said Thursday, putting further price pressure on the pharmaceutical giant’s flagship medicine.  The deal could help the privately-owned German…

Dive Brief: Artiva Biotherapeutics on Thursday raised $167 million in an initial public offering centered around the promise of donor-derived cell therapies for autoimmune diseases. Artiva sold 13.92 million shares at $12 apiece, securing more money than it expected but at a lower per-share price than it had outlined earlier this week. The bulk of the proceeds…

Dive Brief: Sales of Johnson & Johnson’s depression drug Spravato accelerated in the second quarter, putting the medicine on pace to eclipse $1 billion in annual revenue this year. Globally, Spravato sales totaled $271 billion between April and June, a 61% increase from the same period one year before and a 20% jump from the first…

Medical device companies have been steadily cutting jobs for the past 18 months, eliminating thousands of positions as firms look to lower costs, close facilities or restructure businesses. More than 14,000 employees in the device industry have been laid off since the start of 2023 or will lose their jobs in the coming months, according…

Dive Brief: NGM Biopharmaceuticals, which was taken private earlier this year, has raised $122 million from venture investors to advance its recently revamped drug development plans. The Series A round, which NGM disclosed Wednesday, will fund a registrational trial for the company’s drug aldafermin in primary sclerosing cholangitis, or PSC, and a Phase 2 study…

Dive Brief: Biotechnology startup Cardurion Pharmaceuticals on Tuesday raised a $260 million Series B round that will help it build its portfolio of heart disease drugs. Cardurion will use the funds to advance a pair of medicines into mid- and late-stage testing, run studies in newer indications and potentially acquire other assets for cardiovascular diseases….

Vertex Pharmaceuticals’ new treatment for sickle cell disease can eliminate the damaging pain crises people with the blood condition frequently experience, a life-changing benefit that has excited many about the therapy’s promise. However, drugs used to prepare patients for the treatment, called Casgevy, carry a high risk of infertility. Vertex has said it will help…

Dive Brief: An experimental cancer drug developed by Revolution Medicines shrank pancreatic tumors in about one-quarter of participants who had been followed for at least five months after treatment in an early-stage study. The update, which Revolution Medicines shared with investors Monday, is the latest cut of data from the trial, which has tested the…

The popularity of new GLP-1 drugs for weight loss is giving rise to a secondary market with large revenue potential, and companies are vying for a piece of the action. Obesity treatments from Novo Nordisk and Eli Lilly are poised to become some of the most lucrative drugs of all time — Novo’s GLP-1 diabetes…

Dive Brief: Flagship Pioneering said Wednesday that it’s added another $3.6 billion to its capital base, bringing the total raised since 2021 to $6.4 billion. The Cambridge, Massachusetts-based company said $2.6 billion will be allocated into its eighth venture fund, while another $1 billion is set for other uses, including sector-specific strategic partnerships. In November,…

The recent U.S. Supreme Court decision to overturn the Chevron doctrine could open the door to more challenges of Food and Drug Administration regulations, including the agency’s controversial rule on lab-developed tests. In late June, the Supreme Court voted 6-3 to overturn the decades-old Chevron deference principle, meaning that courts no longer must defer to…

Pharmaceutical companies face a looming patent cliff over the next several years, as generic rivals could erode sales of some of the industry’s best-selling medicines. For some drugmakers, copycat competitors are already on the doorstep. Bristol Myers Squibb, for one, could soon hit headwinds for its blockbuster Sprycel as the first generic of the leukemia…

Today, a brief rundown of news from Eisai, Spark Therapeutics and Ipsen as well as updates from Element Biosciences and Novartis that you may have missed. New data from Symphony Health indicate sales of Eisai and Biogen’s Alzheimer’s drug Leqembi totaled $11 million in June, suggesting Wall Street forecasts of around $30 million for the…

Dive Brief: The Food and Drug Administration rejected Novo Nordisk’s application to sell a once-weekly insulin treatment called icodec, sending the Danish drugmaker a series of requests related to manufacturing and its potential use in Type 1 diabetes. Regulators have indicated they can’t complete their review until the requests are resolved, Novo Nordisk said Wednesday….

With tens of billions of dollars at stake, some of the world’s largest drug companies are racing to develop pills with the same power as the weight loss shots that have quickly become among the industry’s best-selling medicines. Pfizer is far behind in that race, but has now selected a new entrant it hopes will…

Today, a brief rundown of news from AbbVie and Skyhawk Therapeutics, as well as updates from Arcutis Biotherapeutics and Zevra Therapeutics that you may have missed. AbbVie on Wednesday named Roopal Thakkar as its chief scientific officer and head of research and development. Thakkar, who joined Abbott in 2003 and continued on to AbbVie after…

Dive Brief: The Federal Trade Commission is preparing to sue the three largest pharmacy benefit managers in the U.S. — CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx — over how they negotiate prices for drugs with pharmaceutical manufacturers, The Wall Street Journal reported Wednesday. The lawsuits will center on PBMs’ business practices related…

Amylyx Pharmaceuticals achieved what all upstart drugmakers hope to accomplish. In less than 10 years, the Massachusetts-based biotechnology company identified a potential medicine, gathered enough evidence to get it approved and started turning a profit. But success was short-lived. A key trial meant to confirm the medicine was effective for ALS instead found it no…

The Federal Trade Commission on Tuesday released a long-awaited report criticizing the pharmacy benefit manager industry for manipulating the drug supply chain to profit at the expense of patients and independent pharmacists. The report, which focuses on PBMs’ pharmacy practices, builds on research finding the companies are contributing to higher drug costs. It could increase…

Dive Brief: Biotechnology company HilleVax on Monday said it will halt development  of an experimental norovirus vaccine in infants after the shot proved ineffective in a large trial, sending shares sliding. HilleVax’s candidate, dubbed HIL-214, failed to meet its primary or secondary goals in the Phase 2b study, which tested its ability to prevent moderate…

Eli Lilly plans to spend $3.2 billion acquiring a Massachusetts-based biotechnology company and its experimental pill for inflammatory bowel disease. Announced Monday, the all-cash deal has Lilly buying all the outstanding shares of Morphic Therapeutics for $57 apiece — a nearly 80% premium to the stock’s closing price on Friday. The companies expect their deal…

Dive Brief: Two years after canceling an initial public offering, Artiva Biotherapeutics has filed a new proposal centered around plans to develop a donor-derived cell therapy for autoimmune disease. The company originally registered for an IPO in April 2021 to support studies of a blood cancer treatment derived from “natural killer,” or NK cells. Eighteen…

Dive Brief: UniQure will sell a gene therapy production plant in Lexington, Massachusetts, to contract manufacturer Genezen in a deal designed to reduce the biotechnology company’s operating expenses. Genezen will pay UniQure $25 million in stock and debt for the facility, as well as offer employment to the “majority” of UniQure staff currently working at…

Dive Brief: Cartesian Therapeutics on Tuesday said an experimental cell therapy it’s developing succeeded in a mid-stage clinical trial of people with the rare autoimmune condition myasthenia gravis, but shares in the biotechnology company fell by double digits nonetheless. According to Cartesian, 10 of the 14 participants who received its therapy and, per the study’s…

Two of last year’s largest biotechnology company acquisitions centered on a new type of treatment for schizophrenia. By the end of September, the first of those therapies could win Food and Drug Administration approval, a decision that would highlight the new attention being paid to psychiatric drugs.  Other novel psychiatric treatments are working their way…

Today, a brief rundown of news from Beacon Therapeutics and Regeneron Pharmaceuticals, as well as updates from Vertex Pharmaceuticals, Johnson & Johnson and Codexis that you may have missed. Gene therapy developer Beacon Therapeutics has reloaded with a $170 million Series B round, which the company said Wednesday will help advance its lead eye disease…

Dive Brief: CureVac, a specialist in messenger RNA-based therapies, disclosed Wednesday plans to lay off 30% of its workforce as part of a “significant strategic restructuring” that will direct the company’s resources toward “high-value” projects. The announcement comes less than three months after CureVac said it would trim 150 jobs to help reduce costs. The…