Countering payers, drugmakers say net prices declined in 2020 (BioPharmaDive)
Gilead's CAR-T med Yescarta gets a leg up on Novartis rival with FDA nod in follicular lymphoma (Fierce)
Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says (Pink Sheet)
How might pharma buddy up with Alexa? Bayer Consumer's first interactive voice ad is food for thought (Fierce)
Biotech IPO market looks to ramp back up as BMS partner Ikena and its immunometabolism therapies eye public offering (Endpoints)
AnaptysBio takes a beating as its lead drug fails its first PhII test. And 5 more trials are nearing a readout (Endpoints)
Further setting the stage for going public, Vivek Ramaswamy’s Roivant readies a deal to buy up a Vant’s stock — cheap (Endpoints)
Argenx’s Autoimmune Disease Blockbuster-In-Waiting Gets FDA Decision Date (Scrip)
Jazz CEO Bruce Cozadd campaigned for 6 months to buy GW Pharma. A 90% premium sealed the deal — along with $17.6M in ‘retention’ incentives (Endpoints)
As viral vector demand surges, fledgling CDMO Matica establishes a beachhead in Texas (Fierce)
AI uncovers Eli Lilly's rheumatoid arthritis drug Olumiant as potential Alzheimer's treatment (Fierce)
Seres stops microbiome cancer trial, deprioritizes drug as COVID-19 throttles enrollment (Fierce)
Gilead’s HIV therapy Biktarvy demonstrates long-term sustained efficacy (PharmaTimes) (Endpoints)
ViiV presents positive long-term data for combined HIV treatment (Pharmafile)
FDA grants Priority Review to Korsuva for CKD-associated pruritis (Pharmafile)
Imfinzi, 2 Other Drugs under PMDA Safety Review (PharmaJapan)
Inside the fall of Watson Health: How IBM’s audacious plan to ‘change the face of health care’ with AI fell apart (STAT)
Medtech
Insulin pump adoption seen climbing 21% in 2021 on wearables boom: survey (MedtechDive)
Harmonization Of The EU Regulatory Compliance Role: Many PRRC Issues To Be Clarified (MedtechInsight)
FDA clears ControlRad tech for reducing cath lab radiation exposure by 85% (Fierce)
Q&A: New Standard For Device Irritation Nudges Industry Away From Animal Testing – And Toward Tests On Lab-Made Human Skin (MedtechInsight)
Government, Regulatory & Legal
Lawmakers rail against huge tax breaks drug wholesalers get from opioid settlement (STAT)
Opioid Litigation Is Prying Open Vaults Of Big Pharma Secrets (Law360)
How Drug Cos. Can Adapt To New Reference Pricing Rules (Law360)
FDA looks to reduce toxic elements in baby food, boost inspections (Reuters)
Generic Drug Claims Chopped Up With Great Efficiency (Drug & Device Law)
Medical Marijuana Is Not Regulated as Most Medicines Are (NYTimes)
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.
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