Recon: Pfizer, BioNTech to develop mRNA shingles shot; French court backs class action over Sanofi’s Depakine drug

ReconRecon | 05 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA pauses domestic drug inspections again, this time to protect against Omicron (Endpoints) (Fierce)
  • FDA Nominee’s Committee Vote Set (Politico)
  • Third former GSK scientist pleads guilty to conspiring to steal trade secrets (Endpoints)
  • Why the conviction of Elizabeth Holmes hinged on defrauding Theranos investors, not patients (STAT)
  • US Biosimilar Approvals In 2021 Were Few But Included Many Firsts (Pink Sheet)
  • US restarts shipments of two mAbs that don't work against Omicron as Merck pills see wider distribution (Endpoints)
  • Califf And Advisory Committees: Will He Push For Reforms (Pink Sheet)
  • Robert Califf is a fervent believer in data. At the FDA, will that be enough? (STAT)
In Focus: International
  • Pfizer, BioNTech to develop shingles shot, after COVID-19 vaccine success (Reuters) (Endpoints)
  • Oncology Dominates China’s 43 New Approvals In 2021, Domestics Emerge To Lead Innovation (Pink Sheet)
  • COVID testing policy put under the microscope as Omicron sweeps world (Reuters)
  • Ireland seeks to buy Merck, Pfizer, GSK COVID-19 antiviral drugs (Reuters)
  • French court backs class action against Sanofi over Depakine drug (Reuters)
  • India says safety concerns restricting use of Merck COVID pill (Reuters)
Coronavirus Pandemic
  • The U.S. government doubles its order for Pfizer’s Covid pills (NYT)
  • What Happened to the Novavax Vaccine? (MedPage Today)
  • Is a Fourth Vaccine Inevitable? (MedPage Today)
  • Bharat Biotech gets approval to test nasal COVID-19 shot as booster – report (Reuters)
  • Israel reports very few myocarditis cases among 12-15 year olds after booster (Reuters)
  • India confirms first Omicron-related death as COVID-19 cases jump (Reuters)
  • In Omnicron Hot Spots, Hospitals Fill Up, but I.C.U.s May Not (NYT)
  • Covid vaccinations are not linked to pre-term births, researchers report (NYT)
  • How fast the omicron variant is spreading in the world (Washington Post)
Pharma & Biotech
  • 3 CRISPR editing innovations to watch in 2022 (STAT)
  • Q&A: Commercial veteran Susan Sweeney mobilizes decades of drug launch experience at Amgen (Endpoints)
  • AstraZeneca hands off epilepsy programs to Ovid; Amylyx scores priority review for ALS drug  (Endpoints)
  • Catalent CEO John Chiminski set to pass the torch this summer after 12 years at the helm (Endpoints)
  • Taking notes from MD Anderson and Rice University, Avenge Bio uncloaks with $45M and a slate of immunotherapies (Endpoints)
  • Blueprint's longtime CEO prepares to step down as biotech revels in new Ayvakit launch, pipeline expansion (Endpoints)
  • Applied looks to next readout as FDA seeks more than biomarker data (BioCentury)
  • FDA warning letter cites product safety issues in Medtronic diabetes group (MedTechDive)
  • EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation (MedTechIntelligence)
  • Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards (MedTechIntelligence)
  • New German Notified Body Designated Under EU’s MDR (MedTechIntelligence)
  • Medtechs brace for hit as hospitals warn of omicron impact on surgeries (MedTechDive)
  • Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage (MedTechDive)
  • The health tech tracker for the first quarter: 13 decisive industry events and deals to watch (STAT)
  • Predicting preeclampsia from a blood test holds promise for pregnancy complications (STAT)
Government, Regulatory & Legal
  • Some drug makers quietly resumed donations to lawmakers who denied Biden’s election victory (STAT) (Fierce)
  • Is CREATES Act Equipped To Handle Biosimilar Complaints? (Pink Sheet)
  • 4 Takeaways From Elizabeth Holmes' Fraud Verdict (Law360)
  • COVID Woes Delay High-Profile Gilead, Samsung IP Trials (Law360)
  • Pharmalittle: Pharma raises median drug prices by 4.9%, so far; Covid forces some lawmakers to ponder pharma gifts (STAT)
  • Ivermectin’s Days in Court (MedPage Today)
  • Medicare Expands Coverage Of Continuous Glucose Monitors (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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