Big Molecule Watch
- The Centers for Medicare & Medicaid Services Announces Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation September 9, 2024 Sam Herron
- PTAB Institutes Sarepta’s IPR September 6, 2024 Alison Siedor
- Update on Recent International Biosimilar Approvals September 3, 2024 Yoko Bian
- Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar September 3, 2024 Kevin DeJong
- FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines September 3, 2024 Emily Rapalino
- FTC Comment on FDA Draft Guidance on Interchangeability August 29, 2024 Beth Ashbridge
- Del. Judge Connolly Says Preambles Are Limiting, Cites Alice in Wonderland, and Invites the Federal Circuit to Weigh In August 28, 2024 Christopher Cassella
- EMA Accepts Marketing Authorization Application for Alvotech’s AVT06 (aflibercept) August 26, 2024 Stephanie Dusaban Gonzales
- Proposed BPCIA Reform Legislation Likely To Have Little Effect Even If Passed August 22, 2024 Elaine Blais|Michael Siekman
- FDA Seeks Input on Biosimilar Product Development Guidance August 20, 2024 Daniel Farraye
BioPharma Reporter
- European Commission grants orphan drug designation for rare disease gene therapy September 5, 2024
- Lilly to collaborate with Haya Therapeutics to develop drugs for metabolic conditions September 5, 2024
- ArsenalBio bags $325 million to develop CRISPR-engineered cell therapies September 5, 2024
- Positive Phase II booster results for Lyme disease vaccine candidate September 3, 2024
- FDA grants expanded approval for Emergent Bio’s mpox vaccine September 3, 2024
- Orgenesis touts early clinical promise of CAR-T therapy with decentralized production in mind September 3, 2024
- Neurocrine’s schizophrenia drug succeeds at phase 2, but dosing questions remain August 29, 2024
- AstraZeneca invests $135M on expanding biologics facility in Sweden August 29, 2024
- New oral cholera vaccine brings hope for global public health August 29, 2024
- EU approves Regeneron’s bispecific antibody following US rejection August 27, 2024