Regulatory Focus™ > News Articles > 2021 > 10 > Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz

Posted 26 October 2021 | By Michael Mezher 

Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz

2704 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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