Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM

Regulatory NewsRegulatory News | 14 December 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron (WaPo)
  • Califf goes to Congress (POLITICO)
  • Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns (STAT)
  • US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ (Pink Sheet)
  • Pfizer says its Covid pill will protect against severe disease, even from Omicron (NYT)
  • Latest on Omicron Variant and COVID-19 Vaccine Protection (NIH Director’s Blog)
  • Omicron now makes up almost 3% of U.S. Covid cases, according to the CDC (CNBC) (STAT)
  • UPS vaccine logistics chief fears more Covid shots ‘returned or destroyed’ due to challenges (CNBC)
  • FDA inspections of dietary supplement facilities fall—again (Natural Products Insider)
  • Minnesota hospitals warn they are 'overwhelmed' in full-page ad (The Hill)
In Focus: International
  • US FDA Looks To Resume Unannounced Inspections In India And China (Pink Sheet)
  • Omicron appears more resistant to Covid vaccines but is causing less severe illness in South Africa, major study finds (NBC)
  • EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19 (EMA)
  • 83 percent surge in COVID-19 cases reported in Africa (The Hill)
  • Denmark and Norway Predict Drastic Spike in Omicron Cases (NYT)
  • UK has 10 people in hospital with Omicron, deputy PM Raab says (Reuters)
  • Vaccines slightly less effective against severe COVID, deaths – WHO (Reuters)
  • India stuck with COVID-19 vaccines it can't export (Reuters)
  • Protect the unvaccinated, then offer boosters - WHO's Ryan (Reuters)
  • Glenmark's subsidiary Ichnos Sciences enters pact with Almirall for novel drug to treat autoimmune diseases (Economic Times)
  • Lupin receives EIR from USFDA for its Goa manufacturing site, shares gain (Economic Times)
  • EU Crunch Time For 15 New Drugs At Final CHMP Meeting Of 2021 (Pink Sheet)
  • MHRA Advertising investigations: November 2021 (MHRA)
Pharma & Biotech
  • Adagio raised $750M+ for an antibody against future variants. It failed against Omicron (Endpoints)
  • Mesoblast shares tank after Novartis abandons a partnership for the biotech's potential Covid-19 treatment (Endpoints)
  • Two Bespoke CAR-T Therapies Post Positive Data (FDA News)
  • Positive top-line Phase III results for rezafungin (Pharmaletter)
  • Lining up a filing for lead ROS1 inhibitor, transpacific oncology biotech AnHeart Therapeutics raises $61M (Endpoints)
  • Samsung Biologics and AstraZeneca expand partnership to include COVID-19 and cancer therapy (Pharmafile)
  • SGS acquires live biotherapeutics focused CDMO (BioPharma Reporter)
  • As dust settles on the Arena buyout, Pfizer exec suggests company will pursue a more aggressive M&A strategy (Endpoints)
  • Eli Lilly steers into Foghorn’s gene traffic control drugs with $380M pact in cancer (MedCity News)
  • New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials (BioPharma Reporter)
  • BMS joins off the shelf cell therapy chase with alliance on Immatics cancer drug (MedCity News)
  • Bellus headed for Phase III in chronic cough (Biocentury)
  • Idorsia hoping to make its dreams come true with a new insomnia alliance (Fierce)
  • New Eye Drops Offer an Alternative to Reading Glasses (NYT)
  • To save lives, overdose antidote should be sold over-the-counter, advocates argue (NPR)
  • Firms Push to Make Birth-Control Pills Available Without Prescriptions (NYT)
  • Gender-neutral iPLEDGE REMS updates for isotretinoin become effective this week (FDA)
  • Baxter completes $10.5B Hillrom acquisition (MedTech Dive)
  • Medtronic's Covidien initiates ventilator recall due to manufacturing error (MedTech Dive)
  • US FDA seeks stakeholder comment on regulatory approaches to 3D printed medical devices (Emergo)
  • IBM Think Tank Pushes for Brain-Computer Interface Safeguards (MD+DI)
  • Brain Chip Combines Electrodes and Microfluidics (IEEE)
  • Can This New Tech Reduce the Need for Skin Biopsies? (MD+DI)
Government, Regulatory & Legal
  • Senators Warren, Rubio Urge DOD to Address National Security, Health Risks from Overreliance on Pharmaceuticals Produced Abroad (Elizabeth Warren)
  • Useful FDCA-Related Decision Arises from COVID Kookiness (Drug & Device Law Blog)
  • Sigma-Aldrich Joins the CRISPR Interference Fray (Patent Docs)
  • Court rejects religious challenge to New York’s vaccine mandate for health care workers (SCOTUS blog)
  • NY Opioid Deliberations Delayed After Rancorous Closing Day (Law360)
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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