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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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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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Regulatory documents show how 89bio’s board pushed Roche hard for a deal valued at $20 per share in upfront and milestone payments.
Looking for a biopharma job in Boston? Check out the BioSpace list of six companies hiring life sciences professionals like you.
In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.
Both Halozyme and Elektrofi have partnered with several Big Pharma companies to provide drug delivery technologies.
President Donald Trump last week announced that 100% pharma tariffs would come Oct. 1, but a White House official has clarified that that’s when the government will “begin preparing” the levies.
Takeda is looking to offload its cell therapy platform and preclinical assets to a yet-unidentified external partner. 137 employees will be let go as part of the move.
With layoffs happening at biopharma companies of all sizes, some may wonder which jobs are safest. Talent acquisition experts spoke to BioSpace about the areas and roles they recommend to biotech and pharma professionals hoping to avoid staff cuts.
At the heart of the agreement is Pfizer’s $70 billion commitment to U.S.-based manufacturing and an exemption from tariffs for three years. While the reaction was mostly positive from Wall Street, other observers noted that the benefits for patients are unclear at best.
As with recent rejections for Biogen and Scholar Rock, manufacturing issues stymied a regulatory bid from Fortress Biotech and Sentynl Therapeutics. Fortress said the FDA did not flag problems with the drug’s safety or efficacy.
Due to policies regarding industry user fees, the FDA will not be able to accept any new drug applications for the duration of the government shutdown, according to Leerink Partners.