Regulatory Focus™ > News Articles > 2021 > 10 > Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expecta

Posted 20 October 2021 | By Michael Mezher 

Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations

2852 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • ‘They rushed the process’: Vaccine maker Novavax's woes hamper global inoculation campaign (Politico) (Reuters)
  • Novavax expresses fresh confidence in its vaccine (Politico)
  • Biogen banks on government coverage to restart stalled Alzheimer's drug sales (Reuters)
  • Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations (STAT)
  • Cigna's pharmacy benefit unit to prefer cheaper insulin drug from Viatris (Reuters)
  • Abbott raises annual earnings outlook as COVID-19 test sales rebound (Reuters)
  • White House lays out plan to vaccinate kids ages 5 to 11 (Reuters) (NYTimes)
  • 'No excuse': ICER determines AstraZeneca's new moneymaker Soliris is vastly overpriced (Endpoints) (Fierce)
In Focus: International
  • Gates Foundation to spend $120 mln to speed access to generics of Merck COVID-19 pill (Reuters)
  • Britain secures COVID-19 antivirals from Merck and Pfizer (Reuters)
  • Sanofi says its flu vaccine can be co-administered with Moderna's COVID-19 shot (Reuters)
  • EU Has Now Designated 30 Notified Bodies For Medtech Products (MedtechInsight)
  • Takeda crashes out of Wave discovery pact at cost of $23M (Fierce)
Coronavirus Pandemic
  • Canada to require COVID-19 vaccinations for federal lawmakers (Reuters)
  • Intrivo launches at-home COVID test that returns results in 10 minutes via AI-powered app (Fierce)
Pharma & Biotech
  • Lung cancer drugs become a growing focus of value-based deals with health plans (STAT)
  • Sage, Biogen head to FDA with $3.1B depression drug; Sana puts down $50M to tap Beam's CRISPR tech (Endpoints)
  • Some cancer patients now have to find other options as Bristol Myers' Abraxane falls into shortage from manufacturing woes (Endpoints)
  • US FDA’s PANDA Policy Could Pose Legal Problems For Biosimilars, Attorney Says (Pink Sheet)
  • J&J dives deeper into bispecifics; SpringWorks announces research deal over Stanford professor's work (Endpoints)
  • AstraZeneca's MCL-1 cancer drug put on hold after flagging a safety issue — 2 years after Amgen axed rival drug (Endpoints)
  • FDA shoots down a biotech’s last-stand patient pitch after faulting data (Endpoints)
  • Radius rockets higher as Kelly Martin boasts of a big PhIII success — but the spoils belong to Menarini (Endpoints)
  • Carl June lends 'wings' to Chinese CAR-T startup led by former postdoc, pursuing off-the-shelf approach with CRISPR flavor (Endpoints)
  • A new Schrödinger-backed startup emerges from the scientist who mapped the first human GPCR (Endpoints)
  • Intuitive says delta variant slows Q3 da Vinci procedure growth (MedtechDive)
  • UK’s Ambitious Plan For Medtech Regulation Merits Attention (MedtechInsight)
  • FDA Reminds Diagnostics Makers Of Rules On Research Using Human Specimens (MedtechInsight)
  • AdvaMed Urges CMS To Leave MCIT In Place (MedtechInsight) (MedtechDive)
  • Castle Biosciences taps into Cernostics' GI cancer test franchise with $80M deal (Fierce)
Government, Regulatory & Legal
  • Elizabeth Warren on over-the-counter hearing aids, health lobbying, and the FDA’s independence (STAT)
  • Theranos boasted of ‘highest levels of accuracy’ in mailings to Rupert Murdoch and other investors (CNBC)
  • Holmes OK'd Testing Claims Over Atty's Concerns, Jury Told (Law360)
  • Teva Fears 'Incredibly Damaging' Parody Videos In Opioid Trial (Law360)
  • Taiwanese Pharma Co. Fights AOP Orphan's Sanctions Bid (Law360)
  • Teva Fights Eli Lilly's Bid To Toss Migraine Drug IP Case (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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