Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children (Reuters)
- Becton Dickinson begins selling new at-home rapid COVID-19 test (Reuters)
- Latest psilocybin patent highlights the swirling battle over psychedelics intellectual property (STAT)
- US will require foreign travellers to get WHO-authorised vaccines (FT)
- NIH enlisted to help FDA assess at-home Covid tests in effort to boost supply (Politico)
- Review of India's Covaxin shot underway, WHO says (Reuters)
- Novartis Weighs Sale or Spinoff of Generic Drug Unit Sandoz (WSJ) (FT)
- African Union to buy up to 110 million Moderna vaccines -officials (Reuters)
- US to defer 33M Covid vaccine doses to Africa (Politico)
- BioNTech eyes construction start for African mRNA vaccine factory in mid-2022 (Reuters)
- France says it has ordered 50,000 doses of Merck's COVID-19 antiviral pill (Reuters)
- EU health agency warns of severe winter flu season for elderly (Reuters)
- How China turned the tables on biopharma's global dealmaking (Endpoints)
- Spikevax: EMA recommendation on booster (EMA)
- European Health Union: Commission establishes portfolio of 10 most promising treatments for COVID-19 (EC)
- Brent Saunders joins $100M Series C for a company out to be the BridgeBio of aging (Endpoints)
- Backed by Eli Casdin, a DNA synthesis company gets a big Series C ahead of its first product launch (Endpoints)
- Licensing biotech breakthroughs is a contentious, painful slog. Can the process be fixed? (STAT)
- FDA is much worse than its regulatory peers at proactively disclosing data, researchers find (Endpoints)
- NICE does not recommend tucatinib for advanced breast cancer (PharmaTimes)
- MHRA licenses uterine fibroid treatment for women in Great Britain (Pharmafile)
- With Sandoz continuing to drag on Novartis, Vas Narasimhan says he may finally be ready for a sale or spinoff (Endpoints)
- Bausch Health’s Salix pilots study to shine light on chronic liver disease and push back on stereotypes (Endpoints)
- Novartis dumps AveXis program for Rett syndrome after failing repeat round of preclinical testing (Endpoints)
- The biotech behind GlaxoSmithKline's PD-1 just scored a $250M cash deal for royalties (Endpoints)
- Mozart Therapeutics makes its official debut, jumping into the hot Treg R&D field with some big-name investors backing it (Endpoints)
- Eli Lilly tosses a marquee pain drug and hits the gas on Alzheimer’s — as Biogen’s suffering opens market to rivals (Endpoints)
- Jennifer Doudna spinout inks a Mammoth CRISPR deal with Vertex worth nearly $700M (Endpoints)
- Notified bodies join chorus of criticism of proposed European AI regs (MedtechDive)
- FDA Targets Makers Of OTC COVID-19 Tests With Tweaks To 2 EUA Templates (MedtechInsight)
- MRA Or Not, Swiss Medtech Industry Urges Maximum Convergence With EU MDR (MedtechInsight)
- FDA shuts down anti-vax lawyer's petition to end Moderna and J&J EUAs (Endpoints)
- Purdue Opposes Requests To Delay Ch. 11 Plan For Appeals (Law360)
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