BioPharma Dive

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Novo abruptly ends obesity drug deal with Hims

5 days ago | biopharmadive.com | Jonathan Gardner

Dive Brief:Novo Nordisk is terminating a marketing deal for its obesity drug Wegovy with Hims & Hers Health just eight weeks after it began, claiming the telehealth company “has failed to adhere to the law which prohibits mass sales of compounded drugs.”Hims had marketed compounded Wegovy under laws that permit it to while a drug is in shortage, but the U.S. government said the shortage ended in February.
FDA to speed reviews for drugs supporting ‘national interests’

1 week ago | biopharmadive.com | Jonathan Gardner

Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the agency’s powers to speed up drug reviews, announcing on Tuesday a plan to evaluate new medicines that address U.S. “national interests,” like a health crisis, in just one to two months.
Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

1 week ago | biopharmadive.com | Jonathan Gardner

Dive Brief:Roche will advance an experimental Parkinson’s disease drug with a mixed track record into late-stage development, announcing Monday that it is “encouraged by the efficacy signals” the medicine displayed in earlier testing despite missing its main objectives in two clinical trials.
Novo, searching for a spark, plans late-stage trials for amylin drug

2 weeks ago | biopharmadive.com | Jonathan Gardner

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

2 weeks ago | biopharmadive.com | Jonathan Gardner

Dive Brief:COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially billions of dollars worth of royalties related to intellectual property on messenger RNA drugs. Per deal terms, each CureVac share will be exchanged for about $5.46 worth of BioNTech’s U.S.-listed shares, valuing the company at $1.25 billion.
Pharma’s wins and losses in the budget bill

2 weeks ago | biopharmadive.com | Amy Baxter

The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. The legislation, which was narrowly approved in the House last month and is now in the hands of the Senate, includes reforms to pharmacy benefit managers and the Inflation Reduction Act. But the bill’s path forward is uncertain.
Concentra to acquire Elevation in bid to eliminate another biotech ‘zombie’

2 weeks ago | biopharmadive.com | Ben Fidler

Elevation Oncology has agreed to be acquired by an investment firm focused on buying struggling biotechs and shutting them down. The cancer drug developer on Monday accepted a bid from Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital Partners. Through the deal, Concentra will pay $0.36 in cash for each Elevation share.
Metsera shares climb on early data for amylin-targeting obesity shot

2 weeks ago | biopharmadive.com | Jonathan Gardner

Dive Brief:An experimental weight loss drug developed by Metsera helped people with obesity lose up to 8% of their body weight over five weeks in an early-stage clinical trial and showed signs it could be administered once monthly, the company said Monday. The drug, code-named MET-233i, is one of many in development aimed at the hormone amylin, a top target of obesity medicines. Metsera hopes MET-233i and others in its pipeline may stand out, however, by lasting longer than existing therapies.
Merck claims study success with PCSK9 cholesterol pill

2 weeks ago | biopharmadive.com | Ben Fidler

Dive Brief:An experimental cholesterol-lowering pill from Merck & Co. succeeded in a pair of late-stage studies, the company said Monday. In one study, Merck’s drug, enlicitide, was tested against a placebo in people already taking statins and who have either an inherited condition that causes high cholesterol or are at risk of atherosclerosis.
FDA meeting gives window into gene therapy field’s angst

3 weeks ago | biopharmadive.com | Ned Pagliarulo

Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ Muldoon. The 10-month-old infant headed home from a Philadelphia hospital this week, dressed in a celebratory cap and gown, after his life-threatening disease was successfully treated with a bespoke CRISPR therapy. While baby KJ is not cured, the treatment has stabilized his disease, a rare liver condition known as CSP1 deficiency, to such extent he’s able to resume eating a normal diet.