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March 15, 2022
by Michael Mezher

Recon: Merck’s COVID pill used widely despite concerns; ICMRA uninvites Russian regulator from meetings for ‘foreseeable future’

 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Merck’s Covid-19 Pill Heavily Used So Far Despite Concerns (WSJ)
  • Merck bid to combine two top drugs for prostate cancer falls short (BioPharmaDive) (Endpoints)
  • Armed with heaps of cash and a veteran team, an upstart looks to disrupt DNA sequencing (STAT)
  • Three years after the Senate grilled drugmakers … nothing’s changed (STAT)
  • Grassley to FTC: Investigate the role of PBMs on out-of-pocket costs (Endpoints)
  • Eisai to receive royalties instead of profits from Alzheimer's drug Aduhelm (Reuters)
In Focus: International
  • International Regulators’ Body Rejects Call To Expel Russian Member (Pink Sheet) (ICMRA)
  • Lilly suspends Russia investments, will continue sale of essential drugs (Reuters)
  • Russia bans exports of some pharmaceuticals and medical devices (Korea Biomed)
  • Illumina launches multiple-gene test to spot rare treatable cancers (Reuters)
  • Novavax's COVID vaccine rollout in EU off to a slow start (Reuters)
  • Rooting for a come-from-behind win, Blackstone infuses $330M into Sanofi's CD38 development plan (Endpoints)
  • After rolling up nothing but positive PhIII data for the FDA and EMA, Astellas' drug for hot flashes registers a fail in Asia (Endpoints)
  • As Sandoz waits for Novartis to determine its fate, the generics player buys out a respiratory device company (Endpoints)
Coronavirus Pandemic
  •  White House, Congress blame game heats up as Covid funding stalls (Politico)
  • Vaccine maker stocks rise as China battles worst Covid outbreak since 2020 (CNBC)
  • AbbVie, eyeing shift to endemic, adds to COVID-19 work with Scripps partnership (Fierce)
Pharma & Biotech
  • Reflections on 10 years of the FDA’s breakthrough therapy designation (Nature)
  • Genome editing products: FDA recommends at least 15 years of follow-up after clinical trials (Endpoints)
  • US FDA Takes A Scientific Look At Hot-Button Issue Of Unannounced Foreign Inspections (Pink Sheet)
  • FDA orders Incyte to hold up yet again in the hunt for blockbuster franchise (Endpoints)
  • After trial flop, Exelixis drops plan to pair Cabometyx with Roche's Tecentriq in early-stage liver cancer (Fierce)
  • Pfizer cancer vaccine science chief poached by Gilead-backed Shoreline Biosciences (Fierce)
  • US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic (Pink Sheet)
  • Exelixis throws in the towel on early-stage liver cancer after final readout shows OS flop (Endpoints)
  • Arrowhead shareholders urged not to approve ‘excessive’ compensation for non-executive directors (STAT)
  • Novo Nordisk, Gates Foundation pledge $90M to fund antiviral research for the next pandemic (Endpoints)
Medtech
  • Novo Nordisk adds bioelectronics, biosensors and stimuli-responsive delivery devices to scope of MIT pact (Fierce)
  • Apyx's surgical device gets FDA warning on off-label skin procedure use (MedtechDive)
  • FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication (FDA)
  • HIMSS 2022: Penumbra Previews Expanded VR Rehabilitation System For Stroke With Planned Launch In April (Medtech Insight)
  • GE Healthcare rolls out digital tool subscriptions for its hand-held ultrasound system (Fierce)
  • FDA slaps LuSys Labs with Class I label for recall of antibody, antigen COVID tests (Fierce)
  • Steep drop in medical device reports on Bayer's Essure in 2021, FDA data show (MedtechDive)
Government, Regulatory & Legal
  • McKesson Agrees to Pay $1 Million to Resolve Recordkeeping Violations under the Controlled Substances Act (DOJ)
  • Watchdog says Lilly made ‘false assertions’ about impact of pausing political donations after Jan. 6 attack (STAT)
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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