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