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Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
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The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The $70 million upfront deal adds to a portfolio of drugs Biogen has been growing in various immunological conditions since 2024.
The cornerstone of the deal is Ixo-vec, an intravitreal gene therapy currently in Phase III development for wet age-related macular degeneration. Eli Lilly made another foray into genetic medicine in June, picking up Verve Therapeutics for up to $1.3 billion.
Of the 25 companies receiving tax incentives in Massachusetts, 23 will add jobs outside of Boston and Cambridge. Medtronic, which is receiving the largest award, will create 220 roles in Billerica. Other recipients include AbbVie, Dyne Therapeutics and Viridian Therapeutics.
In three draft guidance documents, the FDA has laid out pointers to help companies craft better drug development programs and drug applications.
The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.
Sales of Sanofi’s COVID-19 and flu vaccines fell 17% in the third quarter amid declining vaccination rates and pricing pressures in Europe.
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
Viking Therapeutics CEO Brian Lian is watching the growth of interest in MASH and obesity but prepared to go it alone.
Roche has already signed several high-ticket deals this year, including the $3.5 billion acquisition of 89bio and Genentech’s $2.1 billion molecular glue pact with Orionis Biosciences.
In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how small biotechs face mounting pressure amid manufacturing uncertainties.