Skip to content

#FDA

Today 0 items
Oct 9Fri
  1. biopharmadive.com61

    Viatris boosts pain drug portfolio with $1.7B buyout of Pacira

    Viatris is buying Pacira BioSciences for $1.65 billion, paying $36.50 per share in cash, a 45% premium, to gain the non-opioid pain drugs Exparel and Zilretta for post-surgical and osteoarthritis knee pain. Pacira's two main products booked $692 million in sales in 2025, up about 4% from 2024. The deal is expected to close by the end of 2026, with generics for Exparel likely from early 2030 and Zilretta patents expiring in 2031.

    Why it matters: Large-cap pharma M&A in pain therapeutics, with near-term patent cliffs on the acquired products.

Oct 8Thu
  1. biopharmadive.com40

    Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial

    A Netherlands court blocked sales of Merck's subcutaneous Keytruda Qlex in eight European countries, siding with Halozyme in a patent dispute over its under-the-skin drug delivery technology. Separately, Enliven Therapeutics reached agreement with the FDA on a late-stage trial of relcobitinib in chronic myeloid leukemia, enrolling 450 people to test superiority at spurring a major molecular response. Halozyme is also challenging Merck in a U.S. court after a win in Germany.

    Why it matters: Patent ruling blocks subcutaneous Keytruda across Europe and FDA-aligned CML trial design sharpens competition for Novartis and Merck.

Oct 6Tue
  1. biospace.com46

    Compliance concerns hinder rollout of AI in drug manufacturing: Survey

    Fewer than 10% of drugmakers are scaling AI in clinical or commercial manufacturing, according to a CRB survey of more than 400 R&D and manufacturing professionals for its 2026 Horizons report. Use is concentrated in nonregulated areas such as administrative workflows (56%) and drug discovery (45%), with accuracy and quality concerns and insufficient validation standards cited as the main barriers. CRB found that 31% of respondents plan to use AI in regulated manufacturing within three years, and another 31% are considering it without a formal plan.

    Why it matters: Shows regulatory and validation concerns are blocking AI adoption in drug manufacturing, with an FDA warning letter already issued.

Sep 21Mon
  1. STAT News65

    STAT+: Radiopharma companies merge after one receives surprise FDA rejection

    Telix Pharmaceuticals will acquire all shares of ITM Isotope Technologies Munich SE in a merger worth at least $1.65 billion, with up to $700 million more payable to ITM shareholders if ITM's lead drug meets regulatory and sales goals. The deal combines two radiopharmaceutical companies and creates a well-resourced player in a field dominated by Novartis, which launched two radioactive isotope cancer treatments in 2018 and 2022.

    Why it matters: A $1.65 billion radiopharmaceutical merger consolidates the cancer isotope delivery field shortly after an FDA rejection.

Aug 20Thu
  1. fiercepharma.com41

    B. Braun recalls IV solution from US, Canada hospitals on particle contamination concerns

    B. Braun Medical is recalling one lot of Excel lactated ringers injection distributed to hospitals in the U.S. and Canada from late August through September 2024, after identifying potential particulate contamination from cellulose cotton fiber, cellulose wood fiber and polystyrene. As of Aug. 19, no adverse events had been reported, and the recall echoes a sodium chloride recall the company issued in 2024.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org