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In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.
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Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s Alzheimer’s drug Leqembi, which, according to Eisai, could “help reduce the burden on healthcare professionals and patients.”
Out-licensing drugs to multinational corporations is a natural step for Chinese biotechs, but the recent rise in deals is only scratching at the surface of partnership-ready biotechs in the region.
While a substantial portion of pipeline assets are externally sourced, many Big Pharmas are tapping into incubators and venture funds to uncover cutting-edge scientific trends, determine their future focus points and even carve out a niche in an emerging geographical hotspot.
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BioSpace Senior Editor Annalee Armstrong headed to the J.P. Morgan Healthcare Conference with a months-long story idea brewing. Unfortunately, it was one she’s written before.
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Lilly CEO Dave Ricks in Wednesday’s third-quarter earnings call acknowledged that the company is at the mercy of wholesaler stocking decisions.
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The death was linked to acute kidney injury in a patient who had a single kidney remaining and a “complex medical history,” according to CytomX.
Vedanta is parting ways with 23 employees, or approximately 20% of its headcount, after Phase II data for microbiome therapy VE202 failed to demonstrate significant response rates in patients with ulcerative colitis.
Citing other priorities—such as the upcoming U.S.-Russia summit—four anonymous sources claim that pharma tariffs could still be weeks away, according to Reuters.
In this episode of Denatured, BioSpace’s head of insights Lori Ellis discusses the ‘enormous implications’ of patent policy changes with Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck.
Looking for a biopharma job in Texas? Check out the BioSpace list of six companies hiring life sciences professionals like you.
The layoffs will not spare Generation’s R&D team, which will initially be retained while the biotech completes its strategic review but will eventually be let go.
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
President Donald Trump loves a deal, but Most Favored Nation drug pricing isn’t a good one for anyone.
Texas Attorney General Ken Paxton claims that through an alleged kickback scheme Eli Lilly “fraudulently sought to maximize profits at taxpayer expense.”
Insmed’s Brinsupri is the first DPP1 inhibitor approved by the FDA and the first treatment for bronchiectasis to reach the market.