A rare disease first; Lilly’s Alzheimer’s push; Argenx’s next act; Novartis'...
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View ArticleUpdated: Samsung wins FDA approval for second Soliris biosimilar
Samsung Bioepis said Monday that the FDA approved its biosimilar to AstraZeneca’s blockbuster immunosuppressive drug Soliris. And now the company is saying that the approval, for two types of rare...
View ArticleBluebird bio handed negative opinion from federal oversight agency for...
HHS’ Office of the Inspector General has issued a negative advisory opinion for a fertility support program proposed by bluebird bio, less than a week after Vertex sued the federal government over...
View ArticleWuXi AppTec more than tripled lobbying spend as Biosecure Act advanced in...
China’s WuXi AppTec spent at least $360,000 lobbying on the Biosecure Act and other bills before Congress in the second quarter, significantly upping its lobbying work as the company pushed back...
View ArticleWhere Oak HC/FT investor Nancy Brown is placing her bets on AI in health tech
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Nancy Brown used to wear a t-shirt that featured a shiny object and the word “no.” It’s the rule she...
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Health tech startup Commure bets on AI for medical notes in $139M deal
Health tech startup Commure said Friday that it has agreed to buy AI medical scribe company Augmedix for $139 million to beef up its software tools for health systems and doctors. The deal, which will...
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GSK says Dovato was as effective as Biktarvy in head-to-head HIV trial — but...
GSK’s ViiV said its two-drug HIV regimen Dovato was just as effective as Gilead’s three-drug combo Biktarvy in what it says is the largest head-to-head trial of the blockbuster oral drugs. Dovato and...
View ArticleAI-powered biologics biotech Abiologics launches with $50M backing from Flagship
Flagship Pioneering has unveiled a new biotech that’s on a mission to build a new class of biologics with the help of AI. Abiologics, which made its debut on Tuesday with a $50 million commitment from...
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At Third Arc Bio, former J&J leaders raise $165M to test oncology, autoimmune...
After more than a decade steering Johnson & Johnson’s oncology drug R&D, Peter Lebowitz is ready for his next challenge: shepherding the “third arc” of biologics development. “The first one was...
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Bob Langer, Flagship's Stephen Berenson to depart Moderna's board as Carlyle...
Robert Langer is leaving the board of Moderna, the biotech he co-founded and that soared to unexpected heights during the Covid-19 pandemic because of its pioneering mRNA vaccine. David Rubenstein The...
View ArticleDevelopers of next obesity drugs see an opening in shortages, as field...
Ever since the weight loss drug craze created near-unprecedented demand, the first two companies to market have been doing everything they can to meet it by investing in old facilities, building new...
View ArticleTelix's $397M convertible bond offering; Scynexis records a $10M milestone
Plus, news about Windtree Therapeutics, MEI Pharma and ViiV: Telix raises $397M in convertible bond offering: The radiopharma biotech plans to use the funds to advance key programs in its pipeline,...
View ArticleNeurology startup from OrbiMed collab nabs $65M in Series A
Brenig Therapeutics closed a $65 million Series A on Tuesday morning, getting backing from big-name investors such as New Enterprise Associates and OrbiMed. The company will focus on neurology, with...
View ArticleCellectar to seek approval for radioactive iodine-based therapy in rare blood...
Cellectar Biosciences reported Tuesday that 80% of patients with a rare blood cancer evaluated in a pivotal study responded to the company’s iodine-based treatment, and it plans to apply to the FDA for...
View ArticlePfizer lifts curtain on $740M+ extension at API manufacturing site in Singapore
To further entrench its roots in Singapore, Pfizer has opened the doors to a facility extension at a local plant to boost API production for its oncology, pain and antibiotic franchises. The US...
View ArticleUpdated: Merck, without sharing details, says RSV antibody successfully...
Merck’s monoclonal antibody to protect infants from RSV hit its goals in a Phase 2b/3 trial, putting the US drugmaker a step closer to competing against Sanofi and AstraZeneca’s rival product. The...
View ArticleIndian manufacturer Brassica hit with warning letter after employees faked...
The FDA has issued Indian CDMO Brassica Pharma a warning letter after inspectors found employees routinely falsified data records. The regulator inspected Brassica’s facility in the town of Tarapur,...
View ArticleWhat's changed about rare disease medicine
(This is our latest issue of Post-Hoc, a dispatch of analysis and perspectives from the Endpoints newsroom. To get it directly in your inbox, you can modify your subscription preferences here in the...
View ArticleAbbVie files lawsuit in Missouri federal court over 340B contract pharmacies
AbbVie is bringing its legal fight over 340B restrictions to another state. The Chicago pharma giant on Monday filed suit in Missouri over a new state law that would keep drugmakers from imposing...
View ArticleFDA asks adcomm if AstraZeneca needs another study on Imfinzi before and...
The FDA outlined concerns of overtreatment in AstraZeneca’s clinical trial of its immune checkpoint drug before and after lung cancer surgery ahead of a public panel with outside experts on Thursday....
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