Pfizer touts Phase 3 gene therapy data in hemophilia A, but now it needs to...
Can Pfizer do what BioMarin couldn’t in hemophilia A? Pfizer announced Wednesday that its gene therapy for hemophilia A met the primary objective in a key clinical trial, and the company plans to bring...
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BeiGene plots to further build its manufacturing muscle outside of China
With BeiGene opening its first manufacturing facility outside of China, CEO John Oyler told Endpoints News that it has more potential plans expand its production footprint elsewhere. John Oyler The...
View ArticlePalvella’s reverse merger with Pieris; AbbVie’s VC arm invests in anti-aging...
Plus, news about Verastem and OSE Immunotherapeutics: Palvella inks reverse merger: The skin diseases biotech plans to take the Nasdaq spot of Pieris, which laid off most of its staff last year after...
View ArticleBioNTech signs 3D printing deal to develop oral RNA drugs
BioNTech is partnering with a 3D printing company to work on better delivering its RNA-based treatments. The Covid-19 vaccine maker is paying $10 million upfront to Triastek, a company based in...
View ArticleNovartis pays $150M upfront, including $25M in equity, for Dren Bio’s...
Dren Bio inked a research pact with Novartis for select myeloid engagers to treat cancer, marking its second collaboration with a large pharma. The Swiss drug giant will pay $150 million upfront —...
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In a tough market, private biotechs pursue IPOs and buyouts at the same time
Keeping your options open is becoming the thing to do in biotech. Many boards of private drug developers are electing to simultaneously seek an IPO and a buyout at a time when M&A is heating up and...
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Rare pediatric PRV reauthorization faces uncertain fate as summer recess...
With the summer recess for Congress next week, lawmakers will have to move quickly in the early fall if they’re going to reauthorize an FDA voucher program that aims to speed up new treatments for rare...
View ArticleFDA finalizes guidance on using EHR data to support drug submissions
The FDA on Wednesday finalized guidance from 2021 that aims to help pharma companies understand when they may use data from electronic health records (EHRs) or medical claims as part of drug approval...
View ArticleUS bankrolls a third of global Pandemic Fund. Can it get congressional support?
The US Treasury has committed $667 million for a global Pandemic Fund hosted by the World Bank, a third of the $2 billion the fund hopes to raise. There’s just one hurdle: A divided Congress has to...
View ArticleRepublican-led states can't intervene in case on abortion pill restrictions,...
A federal appeals court has unanimously rejected an attempt by a group of Republican states to intervene in a lawsuit seeking fewer restrictions for the abortion pill mifepristone. Mifepristone is...
View ArticleViking to push obesity drug to Phase 3 in bid to reach market faster
Viking Therapeutics is stepping on the gas with its experimental GLP-1/GIP receptor agonist for obesity, forgoing a Phase 2b study and jumping right into Phase 3, the company announced. Viking declined...
View ArticleArgenx to retest Vyvgart in autoimmune platelet disease after failure last year
The Dutch biotech argenx has big plans to develop its drug Vyvgart in more than a dozen autoimmune diseases. But failures in two pivotal studies threw a wrench in that strategy late last year. Now,...
View ArticleIpsen pays Day One $111M upfront for ex-US rights to pediatric brain tumor drug
In another move to boost its oncology portfolio, Ipsen is handing Day One Biopharmaceuticals $111 million upfront so it can take the pediatric brain tumor treatment tovorafenib to market outside the...
View ArticleExclusive: After selling Mirati to BMS for nearly $5B, Chuck Baum lands at...
Mirati Therapeutics’ longtime leader Charles “Chuck” Baum has taken a new job as CEO of Terremoto Biosciences, a Bay Area biotech that’s developing drugs that can bind permanently to challenging...
View ArticleBioMarin snags expanded Brineura label, now approved for all kids regardless...
The FDA has expanded the approval of BioMarin’s treatment for a genetic neurological condition that spurs seizures and twitching in young children. The agency said Brineura can be used in children of...
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Updated: AstraZeneca says there’s ‘very limited’ impact on Farxiga after US...
AstraZeneca has concluded its price negotiations with the IRA for its blockbuster drug Farxiga, in the latest update for pharma companies undergoing the process. Ruud Dobber Ruud Dobber, AstraZeneca’s...
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Roche cuts two more TIGIT trials, plans accelerated timeline for obesity drugs
A year into Roche’s comprehensive portfolio review, the Swiss pharma said it has now taken out 25% of new drug candidates from its pipeline. The ongoing exercise will create room for it to keep...
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Sanofi eyes RSV antibody for its next blockbuster while Dupixent brings in...
Sanofi’s RSV antibody Beyfortus is still on track to reach blockbuster status this year as the company expands manufacturing capacity, according to remarks made Thursday morning by Sanofi executives....
View ArticleManatt scoops up health tech experts Christina Farr and Tom Cassels
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Christina Farr, a health tech investor and former journalist, and Tom Cassels, the former CEO of Rock...
View ArticleNovo Nordisk considers another facility; Lonza’s new CEO shares his priorities
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Novo Nordisk has secured land and planning permission in Denmark to...
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