European Commission president’s second-term pledge: simpler regulations,...
Ursula von der Leyen won a second term as president of the European Commission on Thursday, with 401 votes in favor from a total of 719 in the European Parliament. After her win, von der Leyen...
View ArticleUS inks $113M deal with Siga to bolster smallpox, mpox reserves
The US government is paying Siga $113 million to stockpile additional courses of the smallpox and mpox treatment known as Tpoxx. The project falls under the government’s strategic preparedness plan and...
View ArticleEMA reasserts differences with FDA for Covid vaccine strain selection
The European Medicines Agency (EMA) on Friday reconfirmed that its strain selection for Covid-19 vaccines for the fall season will differ slightly from the FDA’s selection, pending any further...
View ArticleVermont attorney general sues two major PBMs for allegedly driving up costs
The deluge of legal action against pharmacy benefit managers continued Wednesday, with Vermont Attorney General Charity Clark filing a lawsuit claiming that PBMs are behind an illegal effort to drive...
View ArticleChina approves Eli Lilly's weight loss drug as country launches obesity...
Eli Lilly’s tirzepatide has been approved for weight management in China, entering what’s expected to be a substantial market for GLP-1s. Tirzepatide — marketed in the US as Mounjaro for diabetes and...
View ArticleA rare disease first; Lilly’s Alzheimer’s push; Argenx’s next act; Novartis'...
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 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...
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