Recon: California Senate hearing; Moderna and Amgen retire from JPM

Posted on December 14, 2021 | Through Kari oakes

Welcome to Regulatory Reconnaissance, your daily briefing on regulatory news and intelligence.

Focus: United States

  • Former FDA Commissioners Endorse Califf As Agency Head, Citing Urgency To Tackle Omicron (WaPo)
  • Califf goes to Congress (POLITICO)
  • Biotech heavyweights Moderna, Amgen pull out of JPM conference due to Covid concerns (STAT)
  • Woodcock of the American FDA sees a reform of clinical trials coming, but “not quite optimistic” (pink sheet)
  • Pfizer says its Covid pill will protect against serious illness, even from Omicron (NYT)
  • Latest News on Omicron Variant and COVID-19 Vaccine Protection (NIH Director’s Blog)
  • Omicron now accounts for nearly 3% of Covid cases in the United States, according to CDC (CNBC) (STAT)
  • UPS vaccine logistics chief fears more Covid shots will be ‘returned or destroyed’ due to challenges (CNBC)
  • FDA inspections of dietary supplement facilities drop again (Natural Products Insider)
  • Minnesota hospitals warn they are “overwhelmed” with full-page ad (The Hill)

Focus: international

  • US FDA plans to resume unannounced inspections in India and China (pink sheet)
  • Omicron appears to be more resistant to Covid vaccines but causes less severe disease in South Africa, major study finds (NBC)
  • EMA examines new data on the effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19 (EMA)
  • 83% increase in COVID-19 cases reported in Africa (The Hill)
  • Denmark, Norway predict drastic peak in Omicron cases (NYT)
  • UK has 10 people hospitalized with Omicron, Deputy Prime Minister Raab said (Reuters)
  • Vaccines slightly less effective against severe COVID, death – WHO (Reuters)
  • India is stuck with COVID-19 vaccines it cannot export (Reuters)
  • Protect the unvaccinated, then offer boosters – WHO’s Ryan (Reuters)
  • Glenmark subsidiary Ichnos Sciences signs pact with Almirall for new drug to treat autoimmune diseases (Economic Times)
  • Lupine Receives USFDA EIR for Manufacturing Site in Goa, Shares Win (Economic Times)
  • EU crisis time for 15 new medicines at the 2021 CHMP final meeting (pink sheet)
  • MHRA advertising surveys: November 2021 (MHRA)

Pharma & Biotech

  • Adagio has raised $ 750 million + for an antibody against future variants. He failed against Omicron (Endpoints)
  • Mesoblast shares reservoir after Novartis drops partnership for potential biotech Covid-19 treatment (Endpoints)
  • Two bespoke CAR-T therapies publish positive data (FDA News)
  • First positive phase III results for rezafungin (Pharmaletter)
  • Transpacific Oncology Biotech AnHeart Therapeutics Raises $ 61 Million In Preparation For Principal ROS1 Inhibitor (Endpoints)
  • Samsung Biologics and AstraZeneca Extend Partnership to Include COVID-19 and Cancer Treatment (Pharmafile)
  • SGS acquires CDMO (BioPharma Reporter) focused on live biotherapy
  • As dust settles on Arena buyout, Pfizer executive suggests company will pursue more aggressive M&A strategy (Endpoints)
  • Eli Lilly embarks on Foghorn’s gene trafficking-control drugs with $ 380 million cancer pact (MedCity News)
  • New inhaled antibody treatment against SARS-CoV-2 set to enter clinical trials (BioPharma Reporter)
  • BMS Joins Pursuit of Standard Cell Therapy with Alliance on Cancer Drug Immatics (MedCity News)
  • Bellus is heading for phase III in chronic cough (Biocentury)
  • Idorsia hopes to make dreams come true with new alliance against insomnia (Fierce)
  • New eye drops offer alternative to reading glasses (NYT)
  • To save lives, overdose antidotes should be sold over the counter, advocates argue (NPR)
  • Companies push to make birth control pills available without a prescription (NYT)
  • IPLEDGE REMS gender-neutral updates for isotretinoin take effect this week (FDA)

Medtech

  • Baxter completes Hillrom acquisition for $ 10.5 billion (MedTech Dive)
  • Medtronic’s Covidien launches ventilator recall due to manufacturing error (MedTech Dive)
  • US FDA seeks stakeholder comments on regulatory approaches for 3D printed medical devices (Emergo)
  • IBM Think Tank pushes for brain-computer interface backups (MD + DI)
  • Brain Chip combines electrodes and microfluidics (IEEE)
  • Can this new technology reduce the need for skin biopsies? (MD + DI)

Government, Regulation and Legal

  • Senators Warren and Rubio urge DOD to fight national security and health risks of overdependence on overseas-produced pharmaceuticals (Elizabeth Warren)
  • Helpful FDCA-Related Decision Stems From COVID Kookiness (Drugs and Devices Law Blog)
  • Sigma-Aldrich joins the CRISPR interference melee (Patent Documents)
  • Court rejects religious challenge to New York’s vaccine mandate for healthcare workers (SCOTUS blog)
  • New York Opioid Deliberations Delayed After Bitter Closing Day (Bill 360)

Regulatory Recon is our daily intelligence briefing for the Regulatory Affairs space, bringing you key regulatory, biopharmaceutical and medical news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

© 2021 Society of Regulatory Affairs Professionals.


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