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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
Roivant Sciences will wind down operations for Hemavant, which was formed two years ago to advance RVT-2001 as a potential first-in-class treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes.
FDA
Approved in combination with three chemotherapies, Onivyde is the first new frontline treatment option in more than 10 years for adults living with metastatic pancreatic adenocarcinoma.
With last year’s approval of Vertex and CRISPR’s Casgevy, it’s the start of a new era of gene editing. But there are still challenges we must face.
The neuroscience space saw a late push in merger and acquisition activity, while oncology start-ups reeled in the most venture capital funds. Industry leaders expect these trends to continue.
Studies presented Monday at the American Academy of Orthopaedic Surgeons annual meeting show semaglutide has positive impact on outcomes for total hip arthroplasty patients.
Plus, tips for finding biophama job opportunities, and when and how to follow up after a job interview.
The startup will use the money to fund a Phase II trial in combination with Eli Lilly’s Zepbound in the hopes of increased weight loss results, while attempting to protect body composition from muscle wasting.
In the fourth quarter of 2023, Biogen’s revenue from multiple sclerosis drugs fell 8% due to generics competition and the company paid $60 million in close out costs related to Alzheimer’s treatment Aduhelm.