Recon: Gruber and Krause to leave CBER; Sanofi refiles with FTC on $3.2B Translate Bio buyout

ReconRecon | 31 August 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Percentage of Americans who say they won't get vaccinated drops to record low in new poll (The Hill)
  • US demand for COVID-19 antibody treatments rising fast (PMLive)
  • CDC Staff Floats 'Risk-Based Approach' to Potential Booster Doses (MPT)
  • CDC panel unanimously endorses full approval of Pfizer’s Covid vaccine for people 16 and older (CNBC)
  • Nearly 1 million Covid booster shots have already been administered in the U.S., CDC data shows (CNBC)
In Focus: International
  • EU hits target with 70 percent of adults vaccinated (The Hill)
  • EU To Offer Solution To Post-Brexit Regulatory Problems In Northern Ireland (Pink Sheet)
  • Russia again faced with drug shortages (Pharmaletter)
  • Australia in vaccine swap pact with Singapore as COVID-19 cases surge (Reuters)
  • WHO releases new compendium of innovative health technologies for COVID-19, other priority diseases (WHO)
  • Dutch HTA Calls for Big Discount For Pfizer’s Vyndaqel (Pharmaletter)
Coronavirus Pandemic
  •  Moderna vaccine creates twice as many antibodies as Pfizer: research (The Hill)
  • GSK hopes for vaccine success as new shot enters late-stage trial (FT)
  • Japan health minister says Okinawa vaccine contaminants likely from needle stick (Reuters)
  • In the pipeline: What the next wave of COVID-19 vaccines could look like (BioPharma Reporter)
Pharma & Biotech
  • Two top FDA officials in charge of Covid-19 vaccines to leave agency this fall (STAT)
  • ‘Change is messy’: Inside the tumultuous efforts to stabilize BIO, the biotech lobby (STAT)
  • Sanofi refiles $3.2B Translate Bio buyout with FTC to allow more time for review (Fierce)
  • COVID-19 Supplement Approvals Jump, Some On-Time Decision Rates Slip For US FDA (Pink Sheet)
  • DayTwo Scores $37M to Expand Microbiome-Based Personalized Nutrition Treatment for Diabetes (The Health Care Blog)
  • Antiviral nasal drop maker goes public as part of minor SPAC reverse merger (Endpoints)
  • Liquid biopsy: misplaced faith in early cancer detection? (STAT)
  • Catalent expects to see multi-year revenue from COVID-19 vaccine business (BioPharma Reporter)
  • Partnership fights to amplify Black women’s voice in breast cancer research (Outsourcing Pharma)
  • Partial trial hit keeps show on the road for novel Alzheimer's antibody (Pharmaletter)
  • Survey: cancer patients missing out on much-needed genetic testing (Outsourcing Pharma)
  • Innovent inks deal with Bolt Biotherapeutics on cancer drug research (Pharmaletter)
  • A Novartis castoff drug gets new life at an Atlas-backed startup looking to blaze a trail in obesity (Endpoints)
  • Eisai expands deal with Fuji Yakuhin for dotinurad (Pharmaletter)
  • GNT Eyes Unmet Need As Novel Ischemic Stroke Therapy Moves To Phase III (Scrip)
  • A year after a death and accompanying trial hold, Poseida hopes for reprieve with early solid tumor CAR-T data (Fierce)
  • Teva recruits Tal Zaks to its board, offering $300K+ pay package and seamless transition from Moderna  (Endpoints)
  • ARCH-backed George Church spinout shuts down after gene therapy tech struggles in animal models (Endpoints)
  • Reviewing the state of play on cell and gene therapies, with the FDA’s Peter Marks (Pharmaletter)
  • Luca Santarelli's VectivBio buys out small Massachusetts biotech, redoubling focus on metabolic disease (Endpoints)
  • Indian drugmakers see price erosion in US revenue (Pharmaletter)
  • Zimmer 'smart knee' gets FDA nod as ortho rivalry with Stryker heats up (MedTech Dive)
  • Wearable fitness company WHOOP lands $200M in funding, boosting its valuation to $3.6B (Mobi Health News)
  • BioVentus Exercises Option to Acquire CartiHeal (MD+DI)
  • Self-injecting pill could offer oral administration for monoclonal antibodies, insulin and other drugs (BioPharma Reporter)
  • Genome Medical Touts New Acquisition and Financing (MD+DI)
  • Beamtree set to buy health data analytics firm Potential(x) (Mobi Heath News)
  • Abbott's Amulet trial results could lift LAA closure market: analysts (MedTech Dive)
Government, Regulatory & Legal
  • Purdue Pharma Scrambles To Discourage A Justice Department Appeal of Bankruptcy Deal (NPR)
  • Fresenius files IPR petitions challenging Chugai/Roche/Genentech rheumatoid arthritis patents (Big Molecule Watch)
  • Another Birmingham Hip Case Bites the Dust (Drug & Device Law)
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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