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Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.”
New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.
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Gilead Sciences, Inc. announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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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.
The business separation, expected to be completed by the end of 2026, will result in two new companies, one focused on biopharma operations and the other on royalty management.