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November 4, 2021
by Michael Mezher

Recon: UK authorizes Merck's COVID-19 antiviral pill; EMA reviewing AstraZeneca boosters

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna struggles with vaccine ramp-up, cuts 2021 sales view; shares drop (Reuters)
  • ‘The beginning of a long journey’: A progress report on Big Retail’s ambitions in health care (STAT)
  • CAR-T therapies from Bristol, Gilead superior to standard treatment in blood cancer, studies show (STAT)
  • Drugmakers pushed aggressive diabetes therapy. Patients paid the price. (Reuters)
  • Alphabet has a new drug discovery company building on DeepMind’s AI chops (STAT)
  • Manchin doubles down as House puts paid leave in spending bill (The Hill)
In Focus: International
  • Britain approves Merck's COVID-19 pill in world first (Reuters) (NYTimes)
  • EU regulator reviewing data on AstraZeneca COVID-19 booster shots (Reuters)
  • Novartis cuts uneasy 20-year ties to Roche with $20.7 bln voting stake sale (Reuters) (FT)
  • No decrease in effectiveness if COVID-19 jab and flu vaccine is taken together – WHO (Reuters)
  • Medical glove company head accused of fraud in Thailand (The Hill)
Coronavirus Pandemic
  • Biden COVID-19 vaccine mandate for private-sector workers to begin Jan. 4 (Reuters) (STAT)
  • COVID cases break records across Europe as winter takes hold (Reuters)
Pharma & Biotech
  • Older HPV vaccine cuts cervical cancer rate up to 87%, study finds (Reuters)
  • Alzheimer’s conference preview: Aduhelm debate persists, while field grapples with new targets and directions (STAT)
  • PhaseBio claims positive PhII in platelet inhibition reversal; Trial software firm rebrands after hack, merger (Endpoints)
  • Can new drugs punch holes in cancer's protective barrier? For Parthenon Therapeutics, that's the $65M question (Endpoints)
  • FDA+ roundup: FDA chief scientist departs to be deputy surgeon general; New transparency on oncology accelerated approvals (Endpoints)
  • NICE recommends Namuscla for NHS to treat genetic disorder (PharmaTimes)
  • ASH: Chasing AbbVie and J&J's Imbruvica, BeiGene's Brukinsa fleshes out competitive leukemia data again (Fierce)
  • Bayer poaches Otsuka's chief medical officer Koenen to head up its clinical operations (Fierce)
  • Sangamo's Fabry gene therapy clears early clinical test, firing starting gun on preparations for phase 3 (Fierce)
  • US FDA’s New ‘Integrated’ Review Process Starts To Win Over Skeptics, But Industry Still Wants More Details (Pink Sheet)
  • As generation gaps narrow from boomers down to Gen Z, pharma needs to reconsider media, researcher says (Endpoints)
  • More than a year after trimming R&D unit, Ironwood adds a rare disease drug to the pipeline in hopeful step forward (Endpoints)
  • PlateletBio announces $75.5M Series B to extend autoimmune cell therapy (Endpoints)
  • Lonza enters the exosome therapy space with acquisition of still-new Codiak site (Endpoints)
  • In wake of Covid-19 vaccine successes, Moderna scraps an mRNA-based antibody for chikungunya virus (Endpoints)
  • Chimerix unrolls early win for glioma drug picked up earlier this year in acquisition (Endpoints)
  • Bluebird bio completes split into two companies; BeiGene builds out Brukinsa data at ASH (Endpoints)
  • Touting close ties to biotech incubators, Mission BioCapital grabs $275M to help launch startups (Endpoints)
  • Antios Therapeutics' hep B candidate gets another round of applause from investors, closing out a $171M megaround (Endpoints)
Medtech
  • CMS finalizes plans for pay cuts for radiation oncology, other specialists (MedtechDive)
  • FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy (MedtechDive)
  • Varian And Antigen Effects Propel Siemens Healthineers To New Heights In FY21 (MedtechInsight)
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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