FDA finalizes lab developed test rule over industry opposition
Dive Brief: The Food and Drug Administration on Monday released a final rule strengthening its authority over laboratory developed tests, or LDTs, advancing a policy that has drawn fierce opposition from healthcare industry groups. The rule amends agency regulations to…
Repertoire pivot pays dividends with Bristol Myers deal
Dive Brief: Repertoire Immune Medicines, a biotechnology startup formed by Flagship Pioneering, announced Monday a deal with Bristol Myers Squibb to create vaccines that can rebalance the immune systems of people with autoimmune diseases. Repertoire will get $65 million upfront,…
Biogen sees ‘encouraging’ trends for postpartum depression drug
Dive Brief: Biogen has seen “encouraging early trends” in the launch of its postpartum depression pill Zurzuvae, revealing in first quarter earnings drug sales that surpassed the estimates of Wall Street analysts. Biogen said sales of Zurzuvae between January and…
Moderna turns to AI to change how its employees work
Moderna is betting big on bespoke artificial intelligence assistants. The biotechnology company on Wednesday said it has expanded a partnership with OpenAI, the buzzy creator of ChatGPT, to give its thousands of employees access to custom-built AI chatbots. Moderna hopes…
Bristol Myers to cut 6% of workforce, trim drug pipeline
Bristol Myers Squibb will cut 6% of its workforce in a restructuring meant to save $1.5 billion in costs by the end of next year. The layoffs will affect some 2,200 employees, the company said Thursday. It’s also trimming its…
Pfizer hemophilia gene therapy arrives in US to uncertain future
Dive Brief: The Food and Drug Administration on Friday approved a new gene therapy for hemophilia, clearing Pfizer’s Beqvez for certain people with the less common “B” form of the bleeding condition. Beqvez is for adults with moderate to severe…
AbbVie tries to reassure investors on Humira biosimilar threat
Dive Brief: U.S. Humira sales fell 40% year over year during the first three months of 2024, to about $1.8 billion, as biosimilar copycats put pressure on AbbVie’s top-selling drug, the company said Friday in its first quarter earnings report….
BioMarin drops drug programs in pipeline cull
Dive Brief: BioMarin on Wednesday said it’s wrapped up a pipeline review and will stop investing in four experimental therapies because they don’t meet its threshold for patient impact and commercial opportunity. Two of the discontinued programs, BMN 355 for…
AstraZeneca’s earnings surprise investors as cancer drugs fuel growth
AstraZeneca’s revenue and profits grew at a rapid clip over the first three months of the year, beating Wall Street expectations as use of the British drugmaker’s flagship cancer drugs widened. Total company revenue climbed 17% to $12.7 billion and…
Regeneron expands in gene editing with Mammoth deal
Dive Brief: Regeneron Pharmaceuticals is upping its investment in genetic medicine, announcing Thursday a $100 million deal with CRISPR drug developer Mammoth Biosciences. Through their collaboration, the companies plan to develop in vivo gene therapies that combine Regeneron’s viral vector…
Biogen: Don’t expect any big acquisitions this year
Investors who had hoped Biogen would do another flashy deal this year may not want to hold their breath, as the biotechnology company signaled that, at least for the time being, it isn’t looking to make any large purchases “If…
Endeavor pulls in $132M to back cancer, lung disease drugs
Endeavor BioMedicines has raised $132.5 million in a Series C round designed to advance its two experimental medicines deeper into clinical testing, the San Diego company announced Wednesday. The round was led by AyurMaya, an affiliate of investment firm Matrix…
Former Bristol Myers CEO tapped as Novartis’ next board chair
Giovanni Caforio, the former CEO of Bristol Myers Squibb, is set to become the next board chairman of Novartis, which on Tuesday proposed the pharmaceutical industry veteran as its pick to replace Joerg Reinhardt in the role next year. Reinhardt…
Ipsen, Skyhawk to develop RNA-targeting pills for rare brain diseases
Dive Brief: French pharmaceutical company Ipsen will work with privately held biotechnology company Skyhawk Therapeutics to make small molecule drugs that modify RNA. Through a collaboration announced Monday, Ipsen and Skyhawk plan to develop multiple RNA-targeting medicines for rare neurological…
Lilly to buy injectable drug plant in manufacturing ramp-up
Dive Brief: Eli Lilly on Monday said it will acquire a drug plant from Nexus Pharmaceuticals to expand its manufacturing capacity for injectable medicines. Located in Pleasant Prairie, Wisconsin, the facility spans 84,000 square feet and recently passed inspection by…
How can pharma speed time to treatment? Digital tools can help
For patients diagnosed with rare diseases or chronic illnesses, treatment delays can seriously impact health outcomes. A meta-analysis of cancer outcomes, for example, found that every four-week delay in treatment is associated with a 6% to 8% increased chance of death for…
Stelara biosimilar from Alvotech, Teva approved by FDA
Dive Brief: Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara. The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis…
Sage’s cognition drug fails in Parkinson’s study
An experimental drug designed to improve brain function in people with nerve-degrading disorders has failed a mid-stage study that tested it against Parkinson’s disease. The trial enrolled almost 90 participants, who once a day were given either a placebo or…
Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study
Cerevel Therapeutics, a biotechnology company in the midst of being acquired by AbbVie, on Thursday said a Parkinson’s disease treatment it’s developing succeeded in a late-stage clinical trial. The treatment, called tavapadon, helped keep the disease’s disruptive motor fluctuations at…
Roche wins FDA OK for Alecensa in early lung cancer
The Food and Drug Administration has made a medicine from Roche the first specifically available for early treatment of lung tumors driven by a well-known cancer gene. On Thursday, the agency cleared use of the drug, Alecensa, after surgical removal…
Alvotech deal could heighten biosimilar pressure on Humira
Dive Brief: Alvotech and U.S. commercial partner Teva have signed a “long-term agreement” with an unspecified company to boost access to their biosimilar version of AbbVie’s blockbuster drug Humira, Alvotech said Friday. An Alvotech spokesperson declined to provide specifics. The…
Vertex begins bid for US approval of non-opioid painkiller
Vertex Pharmaceuticals is vying for approval of an experimental and closely watched painkiller that could become an alternative to addictive opioids like Vicodin. On Thursday, the biotechnology company said the Food and Drug Administration granted a so-called rolling review of…
23andMe CEO plans to take company private
Dive Brief: 23andMe CEO Anne Wojcicki plans to take the DNA testing company private, according to a Wednesday filing with the U.S. Securities and Exchange Commission. Wojcicki currently owns more than 20% of the firm’s total outstanding shares, and about…
Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo
Dive Brief: Metsera, a richly funded biotechnology startup, launched Thursday with a portfolio of weight loss drugs the company claims could eventually compete with market-leading medicines from Novo Nordisk and Eli Lilly. In its first official announcement, the biotech, whose…
Lilly obesity drug shows benefit in sleep disorder study, pointing to new use
Fresh clinical trial results for Eli Lilly’s drug Zepbound point to a new use for the weight loss medicine in treating a common sleep disorder, adding to evidence the benefits of so-called GLP-1 agonists could extend across a range of…
Intra-Cellular builds case for depression drug with late-stage trial win
An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday. The large trial enrolled almost 500 patients with major depression and hit its…
J&J sees mixed performance from new multiple myeloma drugs
Dive Brief: Sales of Johnson & Johnson’s multiple myeloma medicine Tecvayli more than doubled in the first quarter versus the same period last year, boosting the pharmaceutical company’s oncology business while its cell therapy for the blood cancer, Carvykti, underperformed….
Biotech landlord Alexandria on research clusters and the sector’s recovery
Joel Marcus built a real estate empire on the life sciences industry’s steady growth. Over three decades, his company Alexandria Real Estate Equities has amassed tens of millions of square feet of office and laboratory space in drug development hubs…
Roche reports survival data for new dual-acting lymphoma drug
Dive Brief: Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live longer than people given Rituxan and chemo, the company said Monday. The data could help Roche persuade the Food and…
Keeping cleanrooms clean: Choosing the right laboratory equipment is key
Many of the newest and most promising treatments for what were once incurable diseases incorporate living cells and human tissues. Immunotherapies like chimeric antigen receptor therapy (CAR-T) harness the power of a patient’s own immune system to fight cancer, while…
New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.
When Katherine Wisner began studying postpartum mental health in the 1980s, the field barely existed. Relatively little research was focused on psychiatric illness related to pregnancy, and postpartum depression wasn’t yet well understood. Wisner, now an associate chief of perinatal…
Novartis pauses enrollment in some Kisqali trials to fix manufacturing
Dive Brief: Novartis will pause enrollment in certain clinical trials of its breast cancer drug Kisqali in order to meet regulators’ concerns around impurities related to nitrosamines, the company said Tuesday. The enrollemtn suspension will allow Novartis to adjust its…
Roche, Adaptimmune part ways on cell therapy research
Dive Brief: Genentech, the research subsidiary of Swiss pharmaceutical giant Roche, has decided to cut short a partnership focused on cell therapies for cancer. Forged in September 2021, the deal had Genentech and Adaptimmune Therapeutics collaborate on allogeneic, or “off-the-shelf” cell…
Biotech IPOs bounced back in first quarter, but backlog remains
Initial public offerings by biotechnology companies reached pre-pandemic levels during the first quarter, with nine drugmakers collectively raising more than $1.3 billion, according to BioPharma Dive data. The sum is more than three times the $375 million in total proceeds…
European regulator concludes no suicide link to obesity drugs
Dive Brief: Novo Nordisk and Eli Lilly drugs to treat diabetes and obesity have no “causal association” with suicidal thoughts or incidents of suicide or self-harm, Europe’s health regulator said Friday after a review of health records. As a result,…
US sues Regeneron, alleging false price reporting on Eylea
The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for its top-selling eye drug Eylea. In a lawsuit filed in U.S. District Court in Massachusetts, prosecutors alleged Regeneron failed to…
Century buys a startup, raises funding in cell therapy expansion
Dive Brief: Biotechnology company Century Therapeutics is expanding its autoimmune disease research with a pair of deals that will hand it $60 million in new funding and technology from a private startup it’s acquiring. The funding comes from a private…
J&J, Rallybio partner on drug development for rare fetal condition
Dive Brief: Biotechnology company Rallybio is partnering with Johnson & Johnson, announcing a collaboration Wednesday to develop new treatments for a rare disorder known as fetal and neonatal alloimmune thrombocytopenia, or FNAIT. As part of the deal, Rallybio will receive…
Vertex to buy kidney disease drugmaker Alpine for $4.9B
Dive Brief: Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash. Through the deal, which the companies expect to close…
Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
Dive Brief: Pfizer on Tuesday said it plans to ask regulators to broaden the approval of its vaccine for respiratory syncytial virus, or RSV, after the shot met the goal of a late-stage study testing it in adults as young…
PureTech launches Seaport, hoping to create Karuna 2.0
Hoping to repeat a recent success story, the biotechnology startup creator PureTech Health has launched a new company aimed at developing psychiatric medicines. Seaport Therapeutics officially debuted Tuesday with $100 million from a Series A financing round that received more…
Trial shows Wegovy can ease heart failure symptoms
Dive Brief: Novo Nordisk’s weight loss drug Wegovy helped people with obesity, diabetes and heart failure have fewer cardiovascular symptoms like fatigue and breathlessness, according to clinical trial results detailed Saturday at the annual American College of Cardiology conference in…
Private biotech funding ticks up as venture firms deploy cash
Private funding for biotechnology startups rose during the first three months of the year, suggesting some of the sector’s momentum has translated to stepped-up investment in young drugmakers. Twenty-six companies closed private fundraising rounds worth more than $100 million, according…
Amylyx to pull ALS drug from market in rare move
Amylyx Pharmaceuticals is pulling from market one of the few approved treatments for ALS. Rarely do drugmakers voluntarily withdraw products. In Amylyx’s case, the decision comes just weeks after a large clinical trial meant to confirm the benefits of its…
FDA approves new antibiotic for several hard-to-treat infections
Dive Brief: Swiss drugmaker Basilea Pharmaceutica on Wednesday won Food and Drug Administration approval for its drug Zevtera in a step that could help address the critical need for new antibiotics in the U.S. The FDA cleared the drug for…
J&J to acquire Shockwave Medical for $13.1B
Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal values Shockwave at $335 per share. J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two…
Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use
Dive Brief: The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous…
Boehringer Ingelheim to lay off staff amid biosimilar challenges
Dive Brief: Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company spokesperson confirmed to BioPharma Dive. Stat first reported the news Thursday. The German company said it will trim its customer-facing teams…
Contineum prices biotech’s latest IPO, raising $110M for neuroinflammatory drugs
Contineum Therapeutics has raised $110 million in an initial public offering, the biotechnology industry’s 10th of the year, to advance a group of drugs it’s developing for neurological and inflammatory diseases. The biotech startup on Thursday sold 6.875 million shares…
Merck puts KRAS cancer drug competitor to the test
Dive Brief: Merck & Co. has begun a large clinical trial testing an experimental cancer drug it’s developing for tumors that harbor mutations in a tough-to-target gene called KRAS, The Phase 3 study, which is set to enroll some 600…
Genmab buys ProfoundBio for $1.8B, adding to ADC dealmaking flurry
Dive Brief: Genmab said Wednesday it’s agreed to pay $1.8 billion for ProfoundBio, gaining access to the biotechnology startup’s technology for developing antibody-drug conjugates, or ADCs. ProfoundBio’s portfolio includes Rina-S, a newer type of ADC it claims to be a…
Paragon’s hub-and-spoke biotech model yields another reverse merger
Dive Brief: A third biotechnology company from the startup creator Paragon Therapeutics is heading to the public markets. Paragon’s Oruka Therapeutics, which is developing biologic drugs for chronic skin diseases, announced Wednesday plans to reverse merge with Colorado-based Arca Biopharma….
Diagonal starts up with $128M to make better ‘activator’ antibody drugs
Dive Brief: Diagonal Therapeutics, a biotechnology startup focused on creating antibodies that activate, rather than block, their targets, emerged from stealth Wednesday with $128 million in funding. Created by industry veteran Alex Lugovskoy and seeded by biotech investors Atlas Venture,…
Roivant reveals positive immune drug data, share buyback plans
Dive Brief: An experimental drug being developed by a subsidiary of Roivant Sciences succeeded in a Phase 2 trial testing it for a type of inflammatory eye condition called non-infectious uveitis, Roivant said Tuesday. Patients who received the drug, known…
Verve pauses base editing study after treatment side effect
Verve Therapeutics is pausing enrollment into a pioneering study of a gene editing treatment for heart disease, after a participant developed laboratory test abnormalities. The update, disclosed by Verve Tuesday morning, is a jarring halt to a study that in…
Vertex moves kidney disease drug into late-stage testing
Dive Brief: Vertex Pharmaceuticals on Monday said it will advance an experimental kidney disease drug into Phase 3 testing and expand enrollment to include adolescents between the ages of 10 and 17. The Phase 3 test will evaluate Vertex’s medicine…
Breaking barriers: Advances and challenges in therapeutic cancer vaccines
Imagine a world where we can arm the body’s defenses, pre-emptively training the immune system to unleash a formidable army of tumor-fighting cells. While preventive vaccines have triumphed against specific cancer types, the journey to unlock the true potential of…
European study finds popular ALS drug ineffective
A large clinical trial has found that a drug commonly used by patients with ALS is not effective at treating the nerve-destroying disease. The trial enrolled more than 300 patients across 25 sites in Europe and took nearly four years…
Moderna gets Blackstone backing for flu vaccine R&D
Dive Brief: Blackstone Life Sciences will invest as much as $750 million on influenza vaccine research and development by Moderna, announcing Wednesday a private funding deal that gives the private equity firm rights to future payments and royalties. Moderna has…
‘The heart is back,’ says Cardior CEO, as Novo’s $1B deal boosts field
When the Food and Drug Administration expanded approval of Novo Nordisk’s weight loss medicine Wegovy to also protect heart health, the Danish drug giant had already made a pipeline commitment to developing new cardiovascular treatments. The March 8 approval was…
Bristol Myers says KRAS drug succeeds in key trial
Dive Brief: Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday….
Gilead bets on Xilio cancer drug as biotech restructures
Dive Brief: Gilead Sciences will pay $30 million and invest another $13.5 million in Xilio Therapeutics to access an experimental immunotherapy drug the Massachusetts biotechnology company is developing for cancer. The deal will give Gilead an exclusive license to the…
FDA approves Akebia anemia pill, two years after rejection
Dive Brief: The Food and Drug Administration has approved Akebia Therapeutics’ blood-boosting pill Vafseo for people with anemia from chronic kidney disease, the company said Wednesday, reversing a rejection the agency made two years ago over the drug’s safety. The decision…
Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup
Two years after Art Krieg sold his last biotechnology company to Regeneron Pharmaceuticals, the scientific entrepreneur and industry veteran is quietly building a new drug startup. Called Zola Therapeutics, the biotech is working on what Krieg claims could be more…
Boundless Bio breaks IPO lull with $100M fundraise
Dive Brief: Boundless Bio, a cancer drug developer backed by Bayer and Arch Venture Partners, has raised $100 million in the biotechnology industry’s ninth initial public offering this year. The San Diego-based company priced 6,250,000 shares at $16 apiece on…
FDA approves Merck lung disease drug acquired in $11B deal
The Food and Drug Administration on Tuesday approved a new Merck & Co. drug to treat pulmonary arterial hypertension. Called Winrevair, the drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to…
Supreme Court weighs abortion opponents’ standing in mifepristone case
The Supreme Court on Tuesday heard legal arguments in a high-profile case involving the Food and Drug Administration’s expanded approval of the abortion pill mifepristone, nearly two years after the court overturned Roe v. Wade. Lawyers for the Alliance for…
AbbVie to buy immune drug developer Landos
Dive Brief: Abbvie is expanding its pipeline of inflammatory disease drugs, announcing Monday a small deal to acquire biotechnology company Landos Biopharma. Per the deal, Abbvie will buy Landos for $20.42 per share, or about $138 million. Abbvie has also…
The future of companion diagnostic (CDx) development: Why commercialization is key
As precision medicine expands into a growing number of therapeutic areas, yesterday’s “one size fits all” approach to drug development is becoming less common. Instead, targeted patient populations for new therapies are shrinking, a trend that’s expected to continue as…
Orchard sets out to sell world’s priciest gene therapy
Dive Brief: Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat…
Bayer streamlines pharma leadership team amid company shakeup
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: Bayer CEO Bill Anderson’s structural overhaul is now reaching the highest ranks of the business, as the company reshuffles its…
Thermo Fisher, Bayer partner to develop companion diagnostics
Dive Brief: Thermo Fisher Scientific said Wednesday that it has partnered with Bayer to develop companion diagnostic assays for the drugmaker’s precision cancer therapies. Thermo Fisher will develop the next-generation sequencing-based diagnostics using its Ion Torrent Genexus Dx System. The…
Medicare to cover Novo’s obesity drug for some patients
Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Medicare will cover the costs of Novo Nordisk’s obesity drug Wegovy for some patients with a history of heart disease, a policy…
FDA clears first-of-its-kind Duchenne drug for broad use
Dive Brief: The Food and Drug Administration on Thursday approved a first-of-its-kind drug for Duchenne muscular dystrophy, clearing Duvyzat, a medicine developed by Italian pharmaceutical company Italfarmaco and to be sold in the U.S. by its subsidiary ITF Therapeutics. Duvyzat…
Roche autoimmune disease drug disappoints in closely watched trial
An autoimmune disease drug from Roche and Chugai Pharmaceutical hit its main goal in a closely watched trial, but the results of the study, in a condition called myasthenia gravis, “did not reach our expectations,” the companies said Thursday. Roche…
NextCure to lay off 37% of staff, dial back research plans
Cancer immunotherapy developer NextCure is laying off 37% of its staff and streamlining its research plans, the company said Thursday. Alongside its 2023 earnings, the biotech revealed that it is reducing its workforce from 81 employees to 51. The layoffs…
Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off
The executives behind autoimmune drug developer Prometheus Biosciences are back, armed with more than $400 million to launch their latest venture, a biotechnology startup known as Mirador Therapeutics. Based in San Diego, Mirador looks similar to its predecessor, which Merck…
Acelyrin eye drug heads to late-stage testing after trial win
A young biotechnology company plans to move an experimental medicine for a rare eye disease into late-stage testing after results from a small study signaled that it is generally safe and works as intended. On Wednesday, Los Angeles-based Acelyrin said…
Clasp launches with $150M and a plan for precision cancer immunotherapies
Dive Brief: Biotechnology startup Clasp Therapeutics launched on Wednesday with $150 million in financing to develop a group of dual-pronged cancer immunotherapies for tough-to-treat tumors. The Series A raise led by Catalio Capital Management, Third Rock Ventures and Novo Holdings…
With new data, Bayer readies rival to Astellas menopause drug
Dive Brief: Bayer on Tuesday said it plans to seek regulatory approval of a drug for symptoms of menopause following positive results from a third Phase 3 trial. The drug, dubbed elinzanetant, has already succeeded in two late-stage studies testing…
The digital divide: Balancing automation and human interaction regardless of the patient support program model
In today’s digital age, the promise of a fully automated patient support program (PSP) often falls short of reality. Many hubs, while marketed as digital, rely heavily on manual processes such as e-faxes and e-forms, creating delays and frustrations for…
Bluebird, short on cash, takes on $175M in debt financing
Gene therapy developer Bluebird bio has raised a large debt financing in a bid to extend its cash runway for another year. The company on Monday announced that it’s secured up to $175 million through a five-year term loan with…
Give HCPs a proactive way to reach your field team: Add inbound
Ask a healthcare professional (HCP), and chances are good that they’d like an easy way to reach out to biopharma field reps. In-person meetings are still the gold standard, but adding a digital inbound channel—such as compliant chat or text—fits…
J&J, Novo support Asgard’s push to make ‘in vivo’ cell therapies
Asgard Therapeutics has become the latest emerging developer of “in vivo” cell therapies to attract the attention of large drugmakers. The Swedish biotechnology startup on Thursday raised 30 million euros, or about $33 million, in a Series A round that…
AstraZeneca adds another rare disease drug in $800M buyout of startup Amolyt
Dive Brief: AstraZeneca is bolstering its rare disease division with the purchase of Amolyt Pharma, an endocrine disease specialist backed by Novo Holdings. Under the deal announced Thursday, AstraZeneca will pay Amolyt shareholders $800 million in cash up front, with…
Madrigal, FDA approval in hand, outlines plan to sell MASH drug
The first drug for metabolic dysfunction-associated steatohepatitis will cost $47,400 per year, its developer, Madrigal Pharmaceuticals, said Thursday. Madrigal revealed the price and launch plan for Rezdiffra on a conference call discussing the decision by the Food and Drug Administration…
Bristol Myers cell therapy wins first-of-its-kind approval
Dive Brief: For the first time, the Food and Drug Administration has approved a cell therapy for hard-to-treat forms of two blood cancers. Sold as Breyanzi, the therapy is now cleared for use in certain adults with relapsed or refractory…
FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma
Advisers to the Food and Drug Administration have endorsed the use of two cellular medicines for multiple myeloma earlier in a patient’s disease, overlooking safety concerns raised by agency reviewers earlier this week. The advisory committee on Friday voted unanimously,…
BIO changes stance, backs bill to limit China’s role in US biotech
Dive Brief: The Biotechnology Innovation Organization on Wednesday backed legislation aiming to limit the industry’s association with Chinese life sciences companies that have alleged ties to the Chinese government, including the widely-used contract research and manufacturing company WuXi-AppTec. BIO is…
Madrigal wins FDA approval of first drug for MASH
The Food and Drug Administration has approved the first medicine for a common liver disease that’s been a top target of drugmakers over the last decade. The drug, known as Rezdiffra and developed by biotechnology company Madrigal Pharmaceuticals, was given an…
German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing
Dive Brief: Tubulis, a German biotechnology startup developing antibody-drug conjugates, brought in €128 million, or about $140 million, to bring its first prospects into clinical testing. The startup, which is backed by more than a dozen investors, uses a suite…
FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma
Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions about whether they should be earlier in a patient’s disease, Food and Drug Administration scientists wrote in a briefing document…
After surprise trial failure, ALS doctors brace for one less treatment option
For Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his team treat about 500 people with the rare, fatal disorder that rapidly erodes nerve cells. Friday, though, was particularly difficult….
Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease
Allogene Therapeutics is turning to gene editing startup Arbor Biotechnologies for help developing “off-the-shelf” cell therapies for autoimmune diseases, the companies said Tuesday. Allogene has been a longtime leader in the push to make cellular medicines known as “allogeneic” CAR-T…
Boehringer, Sosei Heptares team up in schizophrenia drug deal
Boehringer Ingelheim has formed a partnership with Sosei Heptares in a deal aimed at developing a new type of schizophrenia medicine, the companies announced Monday. Through the partnership, the two companies will work together to advance a portfolio of medicines…
Roche, following setbacks, turns to its next Alzheimer’s drug
Dive Brief: Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday. A majority of…
Can using SDoH data help identify patient populations who could benefit from weight loss drugs?
Semaglutide has gone viral. Ozempic and other glucagon-like peptide-1 (GLP-1) receptor agonists are so popular that more than 24 million Americans—about 7% of the population—could be taking them for weight loss by 2035, according to the latest estimates. The medications…
Biden proposes strengthening Medicare’s drug pricing power
Dive Brief: President Biden is taking on a bipartisan bogeyman ahead of a critical State of the Union speech, targeting the pharmaceutical industry and saying he will work to expand the government’s power to lower drug prices. In a fact…
Amylyx ALS drug fails crucial study, putting company’s future in doubt
A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major blow to the therapy’s developer as well as patients who had hung their hopes on it. Amylyx Pharmaceuticals disclosed Friday…
Why Cigna is capping cost increases for pricey obesity drugs
Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity medications. The insurer plans to cap annual price increases for the drugs, called GLP-1 receptor agonists, at 15% for employers…
FDA delays decision on Lilly’s closely watched Alzheimer’s drug
Dive Brief: The Food and Drug Administration is delaying an approval decision on Eli Lilly’s experimental medicine for Alzheimer’s disease so it can hold an advisory committee meeting to more closely scrutinize the drug’s safety and effectiveness, the company said…
FDA clears use of Novo’s obesity drug to protect heart health
The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. The agency on Friday approved use of Wegovy to reduce the risk…
Novo’s latest obesity pill spurs major weight loss in small trial
Dive Brief: An experimental pill developed by Novo Nordisk helped obese people lose 13% of their body weight after three months of treatment in a small clinical trial, the company said Thursday, in a result one analyst described as among…
NodThera says inflammation drug has positive effect in Parkinson’s
A Boston-based biotechnology company on Thursday said its most advanced drug showed positive effects in a clinical trial of Parkinson’s disease patients, results that at least one analyst believes could help validate another, similar therapy. The company, NodThera, said that…
Alumis, taking aim at Bristol Myers, pulls in $259M for TYK2 drug work
Dive Brief: Biotechnology startup Alumis on Wednesday raised $259 million in Series C funding to advance a portfolio of oral drugs for autoimmune conditions. Alumis’ top prospects are so-called TYK2 inhibitors, a popular class of medicines being positioned as oral…
European VC Invivo readies its latest fund to back new biotechs
Dive Brief: Barcelona-based venture capital firm Invivo Partners is preparing to close an expected fund of 100 million euros, or $109 million, the third since its formation. In a LinkedIn post on Tuesday, managing partner Luis Pareras said the firm…
Bayer isn’t splitting up, for now
Bayer is keeping its three core businesses under one roof, at least for now, in a decision likely to ruffle some of the company’s investors. Speaking to shareholders Tuesday, Bill Anderson, the former Roche executive and recently minted Bayer CEO,…
Alnylam, Roche blood pressure drug scores in second mid-stage trial
Dive Brief: An experimental RNA-based medicine developed by Alnylam Pharmaceuticals, when added to standard drugs, helped lower blood pressure significantly more than a placebo in a Phase 2 trial of people with uncontrolled hypertension, the company said Tuesday. The drug,…
CVS, Walgreens to start selling abortion pill in some states
CVS and Walgreens plan for the first time to start selling the abortion pill mifepristone just ahead of the start of a Supreme Court case that could have far-reaching implications about its availability. The two pharmacy chains have been certified…
Nocion, chasing GSK, pulls in $62M for chronic cough drug
Investors have poured $62 million into a biotechnology startup developing a drug to treat chronic cough. Nocion Therapeutics, headquartered in Watertown, Massachusetts, announced Monday it completed a Series B fundraise that was co-led by Arkin Bio Capital and Monograph Capital…
Viatris pays $350M to gain two drugs from Idorsia
Dive Brief: Generic drugmaker Viatris has agreed to pay $350 million to Switzerland-based Idorsia for rights to two experimental treatments for heart attack and lupus. As part of the deal announced Wednesday, Idorsia could also receive additional payments for developmental…
Abingworth invests in Trodelvy development in deal with Gilead
Dive Brief: Abingworth, a venture capital group owned by Carlyle, will invest as much as $210 million to help Gilead Sciences further expand the approved usage of the cancer drug Trodelvy. Trodelvy has been approved in the U.S. since April 2020…
Gritstone to lay off 40% of workforce after costly study delay
Gritstone Bio will lay off about 40% of its workforce after missing out on funding it expected to receive this quarter, the company said Thursday. Gritstone, a maker of vaccines for cancer and infectious diseases, is developing a COVID-19 shot…
CDC panel mulls changes to RSV vaccine recommendation
Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursday that would more forcefully encourage some individuals receive a shot. At…
FogPharma pulls in $145M to support cancer drug research
Dive Brief: Cancer drug developer FogPharma has raised $145 million in fresh funding, the company revealed Friday, announcing a Series E round that will give a financial boost to the nearly decade-old biotechnology company. The funding will support development of…
Pfizer, looking for a jumpstart, leans into cancer drug research
Pfizer believes the answer to its sliding valuation lies in oncology. The company, which is coming off one of the worst years in its history, unveiled on Thursday a new business unit dedicated to cancer research. The division, created in…
With BlossomHill, former Turning Point execs take aim at cancer, autoimmune disease
A good track record can be valuable in the uncertain and risky world of drug development. For a group of life sciences investors, it’s worth at least some part of the $100 million they’ve invested in biotechnology startup BlossomHill Therapeutics….
Cure Ventures backs a cell therapy startup targeting Parkinson’s
Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders. Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round…
Women’s health company Obseva to wind down, lay off staff
Dive Brief: ObsEva, a women’s health drug developer, on Wednesday said it plans to wind down its business and let go of all its employees. The company notified the Swiss stock exchange that it might not have the resources to…
Incannex says psilocybin therapy lowered anxiety in small study
An Australian-based biotechnology company says a mid-stage clinical trial has shown that psilocybin, a psychedelic compound found in many mushroom species, helped people with generalized anxiety disorder. The trial recruited 73 participants, giving some psilocybin and others placebos, though they…
Janux shares triple on early cancer immunotherapy data
Dive Brief: Shares in Janux Therapeutics tripled in value Tuesday on early clinical trial results that analysts viewed as a signal the biotechnology company’s technology may yield safer and more potent immunotherapies for solid tumors. The data, disclosed by Janux…
Viking data suggest obesity drug could rival Zepbound, Wegovy
Dive Brief: An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15% of their body weight after 13 weeks of treatment in a mid-stage trial, the company said Tuesday. The drug, a…
GSK drug meets goal in late-stage gonorrhea study
Dive Brief: GSK said Monday that its oral antibiotic succeeded in a late-stage trial in gonorrhea, proving to be as effective as an existing treatment for the infection. According to GSK, the drug, known as gepotidacin, was non-inferior to a commonly…
Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt
Dive Brief: The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected…
Outgoing AbbVie CEO leaves a divisive Humira legacy and lasting impact on pharma
After more than a decade running AbbVie, CEO Richard Gonzalez will step down from his role this summer, ending a tenure marked by the unparalleled ascent of the company’s inflammatory disease drug Humira, as well as a string of controversies…
ORI Capital, the venture firm behind CG’s big IPO, raises new biotech fund
ORI Capital, the China- and U.S.-based venture investor behind the biotechnology sector’s largest initial public offering this year, has raised a new life sciences fund, the firm said Thursday. The $260 million fund is the second for ORI since the…
Novavax agrees to pay Gavi in settlement over COVID vaccine contract
Dive Brief: Novavax will pay as much as $475 million to settle a dispute with Gavi, the Vaccine Alliance over an advance purchase agreement for COVID-19 vaccines. The Gaithersburg, Maryland-based biotech paid Gavi $75 million upfront and is on the…
Moderna pitches RSV shot, new vaccines after ‘difficult year of transition’
Dive Brief: Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter profit that beat Wall Street expectations of a net loss during the final three months of 2023. Full-year sales of…
BioMarin preaches patience amid slow sales for hemophilia gene therapy
Dive Brief: BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia, announcing on Thursday minimal revenue from the treatment, called Roctavian. In its latest earnings report, BioMarin said Roctavian generated $2.7…
J&J secures EMA backing for earlier CAR-T use in multiple myeloma
Dive Brief: The European Medicine Agency’s main drug review committee on Friday supported expanding the approval of Johnson & Johnson and Legend Biotech’s cell therapy Carvykti for earlier treatment of multiple myeloma. The Committee for Medicinal Products for Human Use…
Frontier gets $80M, Galapagos’ backing to make a better KRAS drug
Biotechnology startup Frontier Medicines has pulled in $80 million in new funding to support a targeted cancer drug the company thinks might address some of the limitations of medicines from Amgen and Mirati Therapeutics. The company on Thursday announced a…
Biden administration pledges $100M toward women’s health research
The Biden Administration, through the Advanced Research Projects Agency for Health, has committed to invest $100 million into women’s health research, First Lady Jill Biden announced Wednesday. The investment is part of the White House Initiative on Women’s Health Research,…
NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease
A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation with cell therapy for autoimmune diseases. The paper, which was published in The New England Journal of Medicine on Wednesday,…
Vir, in midst of restructuring, loses its chief medical officer
Infectious disease drug developer Vir Biotechnology on Tuesday disclosed that chief medical officer Phil Pang is stepping down from his role to spend more time with his family. Pang will leave at the end of March, and Vir is now…
AstraZeneca gets new Tagrisso OK as drug succeeds in another trial
Dive Brief: AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday. The FDA cleared Tagrisso together with chemotherapy…
FDA puts hold on Rapt trials of drug for eczema, asthma
Dive Brief: Shares of Rapt Therapeutics fell sharply Tuesday after the company disclosed U.S. regulators ordered a halt of two studies testing a drug the biotechnology company is developing for eczema and asthma. The clinical hold is due to a…
Ce ar trebui să știți despre suplimentele alimentare
despre suplimentele alimentare Suplimentele alimentare pot adăuga vitamine și minerale esențiale în dieta ta. Se găsesc cel mai frecvent sub formă de tablete, capsule, pulberi sau lichide. Suplimentele alimentare completează o dietă sănătoasă, echilibrată, dar nu o pot înlocui. Ele…
Versant-backed Firefly Bio wants to make the next generation of ADCs
Dive Brief: Firefly Bio, a startup working to develop a new kind of cancer medicine, announced Thursday it had raised $94 million in venture funding. The California-based company is putting a spin on antibody-drug conjugates, or ADCs, by merging them…
Aurinia to cut research after sale process fails to find a buyer
Dive Brief: Aurinia Pharmaceuticals will restructure its operations and give money back to shareholders after failing to find a buyer willing to take over the company. Investors can expect a buyback of as much as $150 million worth of stock,…
Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies
Astellas Pharma is delving deeper into cell therapies for cancer, announcing Thursday a research deal to develop a pair of treatments with the help of Boston-based biotechnology startup Kelonia Therapeutics. Through the deal, the two companies will combine their respective…
Gilead reviewing drug acquired in $5B buyout after latest setback
Gilead Sciences is evaluating the future of a cancer drug acquired in a multibillion-dollar deal following a new setback the company reported late Thursday. In a statement, Gilead said it paused enrollment in four mid-stage trials of the drug, known…
FDA to review expanded use of Sarepta Duchenne gene therapy
Dive Brief: The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, the company said Friday Sarepta’s gene therapy, Elevidys, was granted a conditional…
ALS drug from Denali, Sanofi falls short in mid-stage study
Dive Brief: An experimental drug being developed by Denali Therapeutics and partner Sanofi for ALS failed to meet its goal in a Phase 2 trial, the biotechnology company disclosed Thursday via a regulatory filing. The trial, dubbed Himalaya, tested the…
Intellia, ReCode partner on genetic medicines for cystic fibrosis
Intellia Therapeutics will work with a private biotechnology company to develop genetic medicines for cystic fibrosis, with an initial focus on people who have limited or no available treatment options. The collaboration pairs Intellia’s gene editing platform, which is based…
Alnylam changes to heart drug trial spark doubts, sinking shares
Dive Brief: Alnylam Pharmaceuticals is delaying the readout of a closely watched Phase 3 trial in the heart disease transthyretin amyloidosis with cardiomyopathy, revealing Thursday changes to the study’s plan. In a quarterly earnings report, Alnylam said it updated the…
Ipsen drug approved by FDA for early pancreatic cancer
Dive Brief: The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be used with chemotherapy in treating recently diagnosed metastatic tumors, the company announced Tuesday. Onivyde, which Ipsen bought from Merrimack Pharmaceuticals…
Sage offers details on launch of new postpartum depression pill
Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with signs of demand from prescribing doctors. Sage and partner Biogen began selling the drug, Zurzuvae, in mid-December and on Wednesday…
Biogen has a fuzzy line of sight on prized Alzheimer’s drug
One of the world’s largest biotechnology companies wants a new calling card. Long known for multiple sclerosis drugs, Biogen believes its next big franchise will be in Alzheimer’s disease. And key to its ambitions — and near-term growth — is…
BioAge raises $170M to back Phase 2-ready obesity drug
Dive Brief: Biotechnology startup BioAge Labs has raised $170 million to support an experimental pill it plans to test alongside popular weight-loss drugs like Wegovy and Zepbound, the company announced Tuesday. The Series D funding was led by Sofinnova Investments…
CSL heart drug misses goal in large study
An experimental plasma-based infusion developed by CSL failed to keep people at high cardiovascular risk from having heart attacks, strokes or dying from heart-related complications in a major clinical trial, the company said Sunday. The results of the trial, called…
Alys launches with $100M and a pipeline of skin disease drugs
Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100 million from European life sciences investment firm Medicxi. Alys was formed out of the merger of a group of biotechs…
AstraZeneca to invest $300M in US cell therapy plant
Dive Brief: AstraZeneca, looking to build its presence in cell therapy, plans to invest $300 million in a new manufacturing facility in Rockville, Maryland, that will focus on cancer treatments. The facility will manufacture cell therapies for the company’s clinical…
Obesity drug mania takes over Amgen’s earnings call
Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by annual sales. Yet, on a Tuesday conference call discussing Amgen’s fourth quarter earnings, all Wall Street analysts wanted to talk…
BioNTech partners with Autolus to boost cell therapy manufacturing
BioNTech will pay $50 million and make a $200 million investment in Autolus Therapeutics as the company most famous for its COVID-19 vaccine boosts its cell therapy capabilities. Per deal terms, BioNTech will receive royalties on sales of Autolus’ obe-cel,…
Pharma CEOs, pressed by Senate panel, refuse to commit to price cuts
The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the…
Kyverna CEO Peter Maag on courting investors in a ‘volatile’ IPO market
Biotechnology initial public offerings are showing sustained signs of life for the first time in two years, and Kyverna Therapeutics’ larger-than-expected raise on Wednesday is the latest example. The company, a developer of “CAR-T” cell therapies for autoimmune diseases, brought…
Takeda speeds narcolepsy drug to late-stage testing
Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the company enter what Wall Street analysts see as a multibillion-dollar market. There are two kinds of narcolepsy, with a key…
Gene editing biotech Metagenomi pulls off nearly $94M IPO
Dive Brief: Metagenomi, a gene editing startup spun out of research at the University of California, Berkeley, brought in about $93.8 million in the biotechnology sector’s sixth initial public offering of the year. The company on Thursday sold 6.25 million…
Neurona raises another $120M for brain disease cell therapies
Dive Brief: Neurona Therapeutics, a San Francisco-based biotechnology company, has raised another $120 million to fuel its research into cell therapies for brain diseases. Neurona plans to use the money to continue developing a slate of experimental, “off-the-shelf” cell therapies….
Kyverna IPO adds to biotech momentum with $319M fundraise
Dive Brief: Kyverna Therapeutics raised $319 million in a larger-than-expected initial public offering Thursday, adding to an early, but notable, upturn in investor demand for new biotech stock issuances. The company, a developer of cell therapies for autoimmune diseases, sold…
BridgeBio sells partial rights to dwarfism drug for $100M
Dive Brief: BridgeBio Pharma is selling partial rights to an experimental drug for a common form of dwarfism to Japanese pharmaceutical company Kyowa Kirin, the companies announced Wednesday. Per deal terms, BridgeBio affiliate QED Therapeutics will grant Kyowa Kirin rights…
Eisai falls behind on Leqembi patient goal
The Japan-based pharmaceutical firm Eisai had hoped that, by the end of March, 10,000 patients in the U.S. would be taking its closely watched drug for Alzheimer’s disease. But that goal now seems lofty, following updates in the company’s latest…
Lilly sales surge on obesity, diabetes drug demand
Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the company said Tuesday, in the latest sign of surging demand for the therapy and other medicines of its kind. Mounjaro’s…
J&J says top drug prospect works across autoimmune disorders
On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars…
Novo Holdings to buy contract drugmaker Catalent for $16.5B
Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday. In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion…
Biogen quits Aduhelm, handing back rights to original developer
In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment…
Avrobio’s road ends in reverse merger with Tim Springer-backed startup
Dive Brief: The gene therapy company Avrobio agreed to a reverse merger with startup Tectonic Therapeutic after years of struggling with clinical setbacks and a tough financing market for the biotechnology industry. Avrobio investors will likely end up with about…
Roche shuffles early stage pipeline as it joins obesity rush
Roche is reshaping its early-stage pipeline of experimental drugs, jettisoning eight drug candidates in neurological conditions and oncology as it makes room for a set of obesity treatments it gained with its $2.7 billion acquisition of Carmot Therapeutics. The Swiss…
Takeda pays $300M to license Protagonist drug for blood disorder
Dive Brief: Protagonist Therapeutics, a biotechnology company focused on peptide drugs, is teaming up with Takeda Pharmaceutical on an experimental, injectable medicine for a rare blood disorder. Per terms of the deal announced Wednesday, Takeda will pay Protagonist $300 million…
Arch, a prolific biotech creator, is raising $3B for startup investing
Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after…
Brain drug developer Alto Neuroscience prices $129M IPO
Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million…
Merck keeps deal focus with Keytruda patent cliff on horizon
Merck & Co. plans to continue seeking out multibillion-dollar biotechnology deals to supplement its own drug research as it prepares for its dominant cancer immunotherapy Keytruda to lose patent protection later this decade. Merck, which earns about half of its…
Sanofi appoints Nestlé executive as new finance chief
Nestlé veteran François-Xavier Roger will succeed Sanofi chief financial officer Jean-Baptiste Chasseloup de Chatillon on April 1, the French pharmaceutical company said Thursday alongside fourth quarter earnings. Chatillon will be step down from his post to become head of Apprentis…
New CMS pilot to test payment scheme for pricey sickle cell gene therapies
The U.S. government will test whether centrally coordinating insurance coverage can help people with sickle cell disease access expensive new gene therapies for the inherited blood condition. Two such treatments were recently approved by the Food and Drug Administration after…
GSK sales of RSV vaccine stay strong, beating forecast
GSK on Wednesday reported higher-than-expected sales of its RSV vaccine Arexvy, providing further evidence of the product’s strong uptake. The shot brought in 1.2 billion pounds, or about $1.5 billion, last year, notably higher than the range of 900,000 to…
Cour gets $105M, pharma help to ‘reprogram’ autoimmune disease
Dive Brief: Biotechnology startup Cour Pharmaceuticals has raised $105 million to advance a portfolio of medicines for autoimmune diseases. The startup’s funding was co-led by Alpha Wave Ventures and Lumira Ventures and involved large drugmakers Roche, Pfizer and Bristol Myers…
Gilead deepens investment in Arcus and TIGIT drugs
Dive Brief: Gilead has bought a bigger stake in cancer drug developer Arcus Biosciences, announcing Monday it will spend $320 million to own 33% of the company and help speed development of an experimental immunotherapy. With the transaction, the two…
Sarepta data show new Duchenne drug’s potency, but highlight side effects
An experimental drug from Sarepta Therapeutics helped spur production of a crucial muscle-protecting protein that people with Duchenne muscular dystrophy lack, indicating the medicine could be an effective treatment for the degenerative disease. Notably, the clinical trial results shared by…
Bristol Myers gets positive data in subcutaneous Opdivo trial
Dive Brief: An experimental, under-the-skin shot of Bristol Myers Squibb’s immunotherapy Opdivo appeared to work similarly to the approved, intravenous version of the drug, shrinking kidney tumors at an equivalent rate, the company said Saturday. The subcutaneous shot also had…
J&J focuses on newer meds to offset Stelara patent cliff
Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But the pharmaceutical giant faces looming difficulties that hang over its performance, including incoming biosimilar competition to its blockbuster immune drug…
Novo strikes another obesity drug deal
Dive Brief: Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company spun out of Harvard University and Zurich University. · EraCal Therapeutics tests compounds in larval zebrafish in a bid to…
BenevolentAI appoints former Bayer R&D chief as CEO
After a rocky year that featured a restructuring, job cuts and the resignation of its CFO, BenevolentAI is looking to the future by tapping a Bayer veteran as its new CEO. Joerg Moeller, most recently the research and development chief…
RayzeBio drew other pharma interest before Bristol Myers deal
Radiopharmaceutical drugmaker RayzeBio drew interest from two other large drugmakers before agreeing to a $4.1 billion buyout by Bristol Myers Squibb, newly published documents show. The companies, which were not identified in the documents RayzeBio filed with regulators Thursday, both…
PTC Duchenne drug approval set to be revoked in Europe
European authorities are set to rescind the approval of a Duchenne muscular dystrophy drug that’s been on the market there for nearly a decade following evidence the medicine, Translarna, doesn’t appear to help people with the condition. In a statement…
EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma
Dive Brief: Bristol Myers Squibb’s cell therapy for multiple myeloma, Abecma, should be approved for use in patients whose disease has progressed following two standard treatments, the European Medicines Agency’s drugs committee said Thursday. Once the European Commission ratifies the…
Cancer drugmaker ArriVent follows on CG’s heels with $175M IPO
Dive Brief: ArriVent Biopharma is the second biotechnology company to go public this year, raising $175 million in an initial public offering Thursday that will support development of an experimental lung cancer drug. The company sold 9,722,222 shares at $18…
At FDA meeting, experts wrestle with hurdles to developing preterm birth drugs
The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments. At the two-day workshop led…
CG Oncology prices larger-than-expected $380M IPO in hopeful sign for biotech
Cancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a positive sign for a sector that’s struggled to generate demand from Wall Street investors recently. The company on Wednesday sold…
Lilly gene therapy finding puts focus on hearing loss treatment pipeline
An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday. The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small…
Sanofi to buy Inhibrx in deal worth up to $2.2B
Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth up to $2.2 billion. The focus of the deal is an experimental drug Inhibrx is developing for a rare lung…
FDA orders new cancer warnings for CAR-T therapies
Dive Brief: The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the Food and Drug Administration said, following a review of reports involving so-called T cell malignancies following their use. In Jan….
Coherus sells Lucentis biosimilar to Sandoz for $170M
Dive Brief: Coherus Biosciences on Monday said it has agreed to sell its approved biosimilar Cimerli, along with supporting staff, to Sandoz for $170 million in cash. The deal will send to Sandoz, which in October spun out of Novartis…
Gilead ADC medicine misses goal in closely watched lung cancer study
Dive Brief: Gilead Sciences on Monday said its cancer drug Trodelvy missed the main goal of a Phase 3 trial in lung cancer, failing to help keep patients alive longer than chemotherapy after their disease had progressed on earlier lines…
Bayer signals ‘significant’ layoffs in plan to shrink bureaucracy
As part of a makeover promised last year, Bayer is beginning a process of staff reductions that aims to slice through the bureaucracy CEO Bill Anderson blames for the company’s sluggish performance. The German conglomerate said it can’t give a…
BridgeBio strikes drug royalty deal for cash infusion
BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if the medicine, called acoramidis, receives Food and Drug Administration approval. The financing was extended by asset manager Blue Owl Capital…
Five years after Shire deal, Takeda hopes to reap rewards of latest reinvention
Five years ago this month, Takeda Pharmaceuticals completed a $62 billion acquisition of Shire — one of the largest deals in pharmaceutical industry history. The anniversary has resurfaced scrutiny over the buyout’s value and mixed results. The addition of Shire…
Ikena Oncology to lay off 35% of staff
Biotechnology company Ikena Oncology on Thursday said it would lay off staff and reallocate resources toward two experimental cancer drugs. The oncology company is prioritizing the two candidates, dubbed IK-930 and IK-595, over its drug discovery work. As a result,…
Sanders threatens to subpoena J&J, Merck CEOs over drug prices
A Congressional committee may subpoena the CEOs of Johnson & Johnson and Merck & Co. to testify about the differences between the costs of their drugs in the U.S. compared to other countries. The statement from Sen. Bernie Sanders, I-VT, the…
Novartis details first-line data for radiopharma drug Lutathera
A radiopharmaceutical drug from Novartis kept a rare type of neuroendocrine cancer at bay for longer than did standard therapy, according to detailed clinical trial results unveiled by the Swiss drugmaker on Friday. Adding the drug, sold by Novartis as…
Gene therapy biotech Jaguar spins out manufacturing company
Jaguar Gene Therapy is spinning out part of its business to handle the specialized work of manufacturing cell and gene therapies, launching Wednesday a new company called Advanced Medicine Partners. The spinout, which is backed by investors Deerfield Management, Arch…