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The Trump administration’s recently announced fee for new H-1B visa petitions is “completely unreasonable,” an immigration attorney told BioSpace. Attorneys and talent acquisition experts discuss how the fee could impact biopharma and confusion around the proclamation.
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IPO
Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market.
IPO
After spinning out of BridgeBio in May 2024, BBOT had an eye on another round of fundraising in 2025. A SPAC quickly emerged as the best option.
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.
Novartis and Monte Rosa first partnered in October 2024 for a molecular glue asset for immune-mediated and autoimmune diseases. This time, the pharma is putting $120 million down upfront for more of the biotech’s AI-discovered degraders.
CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific drug applications were redundant, but then denied having said the agency would abandon them.
AstraZeneca in January also stopped its $610 million plans to construct a vaccine R&D and manufacturing site in the U.K.
After decades without much movement, a handful of new treatments for this rare autoimmune disease are now approved, and several companies, including argenx and Regeneron, have recently released promising late-stage trial results.
While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss.
FDA
On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.
The settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted.
Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval last year after an advisory committee was unable to verify a favorable risk/benefit profile.
President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines.