Recon: NYT says Abbott destroyed COVID tests when sales dwindled; Woodcock out of running for FDA commissioner?
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- Maker of Popular Covid Test Told Factory to Destroy Inventory (NYT)
- Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee (Bloomberg)
- Child Covid-19 hospitalizations soar, filling pediatric wings, data show (NBC)
- White House: More than one million vaccine doses administered in past 24 hours (The Hill)
- Three senators announce positive COVID-19 tests in single day (The Hill)
- That $56,000 Drug? Blame Medicare. (NYT)
- House Democrats press insulin manufacturers for lower prices (The Hill)
- WHO: Call for experts to join Scientific Advisory Group for the Origins of Novel Pathogens (WHO)
- 'Moderna Of China' Gets $700m Injection As Investors Bet Big On Domestic mRNA Vaccines (Scrip)
- Dealmaking and bispecifics cut trail to IPO for Y-Biologics (Biocentury)
- UK approves rollout of ‘first of its kind’ Covid antibody treatment (MHRA) (Guardian) (BioPharma Reporter)
- Moderna secures extended vaccine supply with Canada, sees regulatory advances (Biopharma Reporter)
- AstraZeneca to seek regulatory approval for COVID-19 prevention antibody (Biopharma Reporter) (Fierce) (Endpoints)
- Fauci says U.S. is expanding Covid vaccine manufacturing to donate more doses to the world (CNBC)
- USP Expands Global COVID-19 Response to Tackle Substandard & Falsified Vaccines (USP)
- J&J seeks nod for COVID-19 vaccine trial in Indian adolescents (Reuters)
- J&J veteran Joaquin Duato to take over as chief executive (FT) (Biocentury)
- Moderna is Launching Trials of Two mRNA Vaccines Against HIV (FDA News)
- NICE Recommends First Treatment for Rare Blood Disorder (Rare Daily)
- We asked our biopharma readers about their company's policies on vaccine mandates. Feelings are running strong (Endpoints)
- More Than Advisers: Survey Shows FDA Advisory Committee Members Want More Power (FDA News)
- After company protest, FDA agrees to review controversial drug to prevent premature birth (STAT)
- Beckley raises $80 million for psychedelic drugs (C&EN)
- Vigil Raises $90 Million to Advance Pipeline to Treat Neurodegenerative Diseases (Rare Daily)
- EC nod for Astellas, FibroGen’s roxadustat for chronic kidney disease (PharmaTimes)
- Fate's closely watched stem cell-derived NK program raises red flag over durability of response (Endpoints)
- AstraZeneca's Alexion halts ALS trial on lack of efficacy (Reuters)
- Despite upbeat tones from analysts, Fate Therapeutics' stock drops on blood cancer readout (Fierce)
- Lilly separates a neuroscience research group (C&EN)
- FDA Grants Fast Track Designation to Senhwa’s Silmitasertib to Treat Recurrent SHH Medulloblastoma (Rare Daily)
- EC approves BMS cell therapy for multiple myeloma (PMLive)
- UK’s NICE to revamp its processes to make access to medicines “fairer” (PMLive)
- A new technology, based on a quirk of evolutionary biology, may be the next big thing for CRISPR (STAT)
- Atopic dermatitis: an expanding therapeutic pipeline for a complex disease (Nature Reviews Drug Discovery)
- Akili strikes $37.5M licensing deal for another game-based treatment (MedCity News)
- Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11 (FDA)
- 3D-Printable Biomaterial Takes Shape for Tissue Scaffolds (MD+DI)
- NY Decries 'Brazen Gaslighting' By Endo's Opioid Attys (Law360)
- Biotech co-founder settles accusations of faked research data (Fierce)
- Judge Urges Attention to Individual Stories in Purdue Ch. 11 (Law360)
- States Scurry Ahead of Saturday’s $26 Billion Opioid Settlement Deadline (FDA News)
- E.D. Pa. Judge Dismisses All Claims in Sloppy IVC Filter Complaint (Drug & Device Law)
- AbbVie, Janssen Win IP Fight Over Cancer Drug Imbruvica (Law360)
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