Recon: FDA approves Roche’s Polivy for first-line lymphoma treatment; Bristol pays Tubulis up to $1B to deepen ADC pipeline
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA Green Lights Roche’s Polivy in First-Line DLBCL (Endpoints) (Fierce)
- FDA’s new plan to study opioids’ effectiveness faces resistance (STAT) (Endpoints)
- SCOTUS offers another short-term extension for abortion pill's approval (Endpoints) (BioSpace)
- GenBioPro Sues FDA To Keep Generic Mifepristone Available; Supreme Court Delays Its Decision (Pink Sheet)
- Four senior FDA leaders forged close ties with Biogen well ahead of Aduhelm's approval. Now they've left FDA (Endpoints)
- What Carrots Will US FDA Offer For Quality Management Maturity Participation? (Pink Sheet)
- Drug Industry Middlemen Fees Targeted for Savings in Senate Plan (Bloomberg)
- Biden to tap head of National Cancer Institute to lead NIH (STAT) (Endpoints)
- The NIH has poured $1 billion into long Covid research — with little to show for it (STAT)
- Pharma Decries Drug Selection Plans in Medicare Pricing Policy (Bloomberg)
- Discrimination lawsuit against HHMI spotlights barriers faced by scientists with disabilities (STAT)
- EMA Finalizes Key Guideline On Use Of Digital Tech To Capture Electronic Trial Data (MedTech Insight)
- Global Harmonization Efforts Must Go Further (Pink Sheet)
- Where Do The EU & The US Stand On Decentralized Clinical Trials? (Pink Sheet)
- Confidence in childhood vaccines dropped during COVID-19 pandemic: UNICEF (Fierce)
- WHO launches mRNA vaccine hub in Cape Town (Reuters) (Fierce)
- India's Serum in talks on fill-finishing malaria vaccine in Ghana, official says (Reuters)
- Ireland added to EMA/FDA joint generic inspection initiative (EMA)
- Ireland, Belgium and The Netherlands Withdraw From Libmeldy Gene Therapy Pricing Talks (Pink Sheet)
- Bristol to Pay Tubulis Up to $1 Billion in Cancer-Drug Deal (Bloomberg) (Endpoints) (Bioprocessing International)
- Abdera raises $110M to push targeted radiotherapies where they haven’t gone before (Endpoints)
- In a leaked abstract, J&J's cell therapy appears to have dramatic benefits for multiple myeloma patients (Endpoints)
- European biotech VC Forbion closes two funds at $1.5B total in its biggest raises to date (Endpoints)
- Moderna and IBM to Explore Quantum Computing and Generative AI for mRNA Science (BioSpace)
- BeiGene's gastric cancer drug succeeds in late-stage trial (Reuters) (Fierce)
- Roche's Foundation Medicine lays off 135 workers (Endpoints)
- ‘Get Ahead Of The Curve’ By Preparing for EUA End, Attorneys Say (MedTech Insight)
- Fresenius Kabi recalls newly acquired infusion pump over possible leaks (Fierce)
- Medtronic embarks on monthslong global layoffs, with total cuts unknown (Fierce)
- Abbott signals recovery in device sales as hospital staff shortages ease (Reuters) (Fierce)
- UK watchdog says Cochlear's Oticon Medical deal could harm market (Reuters)
- Veeva study cites timely data entry, quality as biggest medtech trial challenges (Fierce)
- Amgen nabs appeals win against Otezla generics, blocking Sandoz and Zydus copycats until 2028 (Fierce)
- FDA Asked to Weigh in on Pregnancy Warning in Pain Relief Suits (Bloomberg)
- Purdue Warns OxyContin Copies’ Launch Would Imperil Opioid Deal (Bloomberg)
- US veterans suing 3M over earplugs seek to stop unit's 'false alarm' bankruptcy (Reuters)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
