EMA 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 ArticleIonis flashes new Angelman syndrome data, will pursue Phase 3 trial next year
Ionis on Monday revealed new six-month data from its Angelman syndrome program, presenting Phase 1/2a results from a pooled group of patients taking three different doses of ION582 and saying it’s...
View ArticleSEC staff recommends enforcement action against Allarity over potential...
Struggling biotech Allarity Therapeutics received notice from the Securities and Exchange Commission that the agency’s staff has recommended it take action against the company over alleged violations...
View ArticleLayoffs at Rapt Therapeutics after winding down mid-stage trials of lead drug
Rapt Therapeutics is slashing its headcount by 40% to extend its cash runway, just months after it ended Phase 2 studies of its lead immunology candidate, zelnecirnon. The California biotech plans to...
View ArticleGrünenthal inks a deal with Valinor; Valneva gets $41M from CEPI
Plus, news about Cellectar Biosciences and Innovent: Grünenthal acquires Valinor Pharma for $250M: Grünenthal is set to become the “global owner” of the US biotech and the opioid-induced constipation...
View ArticleChinese biotech Gan & Lee boasts competitive Phase 2b weight loss data for...
Fresh off Eli Lilly’s tirzepatide approval for weight loss in China, Beijing-based Gan & Lee Pharmaceuticals posted Phase 2b data of its GLP-1 rival that stacks up positively against market...
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HI-Bio dishes on motivations for Biogen buyout, citing desire to move fast
Why did Human Immunology Biosciences get bought out less than five months after closing a $95 million Series B? HI-Bio’s executives were highly confident in the company’s lead program, felzartamab, and...
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Agilent Technologies to acquire CDMO Biovectra for $925M
Agilent Technologies plans to buy Canadian CDMO Biovectra in a $925 million deal, which Agilent says will deepen its focus on oligonucleotides and CRISPR. Biovectra says it has fill-finish services,...
View ArticleSino Biopharm's invoX to restructure, likely cutting about 60 roles
Oncology and respiratory drug developer invoX Pharma is fine-tuning its pipeline and expects to cut about one-third of its employees, the company confirmed to Endpoints News. London-based invoX has...
View ArticleNorth Carolina's Medicaid program to cover weight loss drugs beginning in August
North Carolina will join the list of several states that have started covering obesity drugs, citing the positive effect they can have not just on weight, but with the comorbidities that often...
View ArticleSamsung wins FDA approval for second Soliris biosimilar
Samsung Bioepis said Monday that the FDA approved its biosimilar to AstraZeneca’s blockbuster immunosuppressive drug Soliris. But the approval, for two types of rare blood disorders, didn’t come with...
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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