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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.