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PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The vaccine maker’s fourth-quarter revenue and earnings on Wednesday missed Wall Street expectations, while providing full-year 2024 sales guidance of flat to lower than last year.
Plus, last week Richard Gonzalez announced his retirement from AbbVie, PhRMA appointed Gilead’s O’Day to chair its board and Joseph Papa became president and CEO of Emergent.
AbbVie continued its dealmaking spree Wednesday by partnering with OSE Immunotherapeutics to develop its early-stage, first-in-class antibody for chronic and severe inflammation.
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez ⁠navigated Humira’s LOE⁠, his victorious retirement ⁠announcement⁠, and the future of biosimilars.
The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.
More than two years after an FDA rejection, AstraZeneca has given back to FibroGen U.S. and rest-of-world rights to the HIF-PH inhibitor, though the companies will maintain their contract in China and South Korea.
Amid the dual crises of worsening medicine quality and growing drug shortages, the FDA plans to increase inspections of Indian manufacturing facilities this year, Reuters reported Tuesday.
The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.
From entering college in China at just 15 to co-inventing a drug for Bayer, Mei’s career journey has been far from average. Now CMO at Editas, he’s not done yet.
The biopharma industry in Nigeria takes a hit as GSK and Sanofi shut down their commercialization efforts in the country.