FDA approves Humacyte’s lab-grown blood vessels
Twenty years ago, Laura Niklason founded a company that sounded like something out of science fiction. The Duke University bioengineer and anesthesiologist was working in the budding field of...
View ArticleRhythm receives expanded approval for genetic obesity drug
Rhythm Pharmaceuticals received FDA approval to market its genetic obesity drug Imcivree for children as young as 2 years old. Friday's action will let the drug be used to treat excess body weight and...
View ArticleFDA's Califf predicts Ramaswamy-RFK battle over agency
FDA Commissioner Rob Califf has only a few weeks left before he steps down with the change in administrations. But he recently predicted that the next person to head the agency will face a ...
View ArticleAccelerated approval brings Pfizer's BRAF inhibitor to first-line patients
Pfizer scored an accelerated approval Friday to bring its BRAF inhibitor to first-line colorectal cancer patients. Braftovi was approved in combination with cetuximab, also known as Eli Lilly’s...
View ArticlePBM changes unlikely to join spending bill as shutdown looms
With the federal government staring down a midnight deadline that could lead to the furlough more than 40,000 staff at the Department of Health and Human Services, several significant healthcare...
View Article2024's biopharma winners and losers; CagriSema falls short; Merck swings...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleVertex gets 'vanza triple' approval and Trikafta expansion
The FDA on Friday issued two simultaneous cystic fibrosis approvals for Vertex Pharmaceuticals but included high-level safety warnings for both. The first approval is for Vertex’s “vanza triple”...
View ArticleNovo Nordisk’s once-daily hemophilia drug Alhemo is approved
Novo Nordisk finally won US approval for its hemophilia drug Alhemo following the product’s rejection by the FDA last year. The once-daily shot may now be used to reduce the frequency of ...
View ArticleFDA approves Lilly weight loss drug Zepbound for sleep apnea
Eli Lilly’s weight loss juggernaut Zepbound has been approved in the US to treat sleep apnea, and the label expansion could open the door to Medicare coverage for the drug for the first time. ...
View ArticleInmagene to join Nasdaq through reverse merger with Ikena
Inmagene Biopharmaceuticals, a biotech developing immunology treatments, will take over the Nasdaq listing of Ikena Oncology in a reverse merger that ends the target company's search for a closing...
View ArticlePDUFAs for Tonix and Nuvation; Sanofi vaccine partnership; RAPT allergy deal
Tonix Pharmaceuticals has received a PDUFA date of Aug. 15, 2025, for its non-opioid pain drug for the treatment of fibromyalgia. It claims the drug, TNX-102 SL, would be a first ...
View ArticleBristol Myers' TYK2 inhibitor succeeds in pair of Phase 3 psoriatic arthritis...
Bristol Myers Squibb’s bet on TYK2 continued to pay off Monday, as Sotyktu passed two more Phase 3 tests in psoriatic arthritis, the company announced. Both pivotal trials met their primary endpoint,...
View ArticleJim Wilson's GemmaBio raises $34M to commercialize gene therapies for rare...
GemmaBio, a company founded by gene therapy pioneer Jim Wilson, has raised $34 million in seed funding to try and resuscitate the floundering gene therapy field.
View ArticleNext pipeline drugs for weight loss after CagriSema disappointment
The weaker-than-hoped weight loss seen with Novo Nordisk’s CagriSema knocked the company’s shares badly on Friday. The Danish group spearheaded the GLP-1 revolution, but is now in danger of being...
View ArticleSumitomo’s overactive bladder drug adds another indication
Sumitomo Pharma’s oral treatment for overactive bladder symptoms won an expanded label from the FDA, and is now approved to treat men who are simultaneously receiving therapy for prostate enlargement....
View ArticleDeerfield to buy Singular Genomics, beating out rival
An affiliate of Deerfield Management Company will acquire Singular Genomics Systems, ending a months-long competition between two suitors that bid up the price of the DNA sequencing company. The...
View ArticleViatris' India-based manufacturing site blocked from shipping 11 generic...
Generic drug firm Viatris announced Monday that one of its India-based manufacturing facilities has been placed on import alert by the FDA following receipt of a warning letter for deficiencies cited...
View ArticleDrugmakers sue government over 340B discounts to STD clinics
Amgen, Eli Lilly and UCB sued the federal government, claiming that several STD clinics getting drug discounts under the federal 340B aren't actually eligible. In their joint lawsuit filed Friday, the...
View ArticleCMS explains what went into its first round of drug price negotiations
The Centers for Medicare and Medicaid Services on Friday released detailed but heavily redacted explanations of how it determined new prices for the first 10 drugs negotiated under the Inflation...
View ArticleFederal appeals court says Teva must delist Orange Book inhaler patents
The Federal Trade Commission is praising an appeals court decision calling for Teva to delist five inhaler patents from the FDA’s Orange Book. The case relates to Amneal’s efforts to market a generic...
View ArticleWuXi AppTec sells cell and gene therapy business to investor
WuXi AppTec will sell its Advanced Therapies unit to the US private equity firm Altaris for an undisclosed amount, a long-anticipated move after months of concern that Congress would pass legislation...
View ArticleBioNTech settles with NIH, UPenn in Covid vaccine disputes and will pay...
BioNTech has entered into settlement agreements with the NIH and the University of Pennsylvania, marking a key turning point in the long-running disputes and the inking of royalty payments. The...
View ArticleJ&J partners on STAT6; AstraZeneca, Daiichi withdraw lung cancer drug EMA app
Johnson & Johnson is partnering with the Japanese company Kaken on a STAT6 program. J&J will get the rights to KP-723, an oral STAT6 inhibitor still ...
View ArticleFDA approves subcutaneous version of Bristol Myers' Opdivo
A decade after Bristol Myers Squibb first won approval for its PD-1 checkpoint inhibitor Opdivo, the cancer drug has been approved in a subcutaneous form that's becoming a new area of competition for...
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