Regulatory Focus™ > News Articles > 2021 > 9 > Recon: CDC chief overrules panel on boosters for at risk workers; GE drops $1.45B to buy imaging fir

Recon: CDC chief overrules panel on boosters for at risk workers; GE drops $1.45B to buy imaging firm BK medical

Posted 24 September 2021 | By Michael Mezher 

Recon: CDC chief overrules panel on boosters for at risk workers; GE drops $1.45B to buy imaging firm BK medical

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • GE Healthcare drops $1.45B to buy BK Medical, bringing its ultrasound franchise to the OR (Fierce)
  • CDC Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk (NYTimes) (Reuters)
  • Biden announces expanded booster rollout amid confusion over eligibility (Politico) (STAT)
  • Boosters for Moderna and Johnson & Johnson vaccine recipients weren’t up for debate during a CDC panel. (NYTimes)
  • Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug (BioPharmaDive)
  • FDA's ODAC will review 2 more dangling accelerated approvals for multiple myeloma, leukemia (Endpoints)
  • HHS lines up Novartis, Lilly, AstraZeneca and 3 other drugmakers for fines due to drug discount violations (Endpoints)
In Focus: International
  • CBD trial to treat hallucinations in Parkinson’s disease (BBC)
  • Australia shores up Pfizer supply after days of uncertainty (The Guardian)
  • WHO backs Regeneron COVID-19 drug cocktail as UN body calls for equal access (Reuters) (NYTimes)
  • Mexico to use only Pfizer COVID-19 vaccine on at-risk kids (Reuters)
  • Pfizer in talks over full license for COVID-19 vaccine in Singapore (Reuters)
  • CanSinoBIO's COVID vaccine, tested at lower dosage, safe for children -study (Reuters)
  • France, Germany nominate WHO chief for second term (The Hill)
Coronavirus Pandemic
  • Burnout and fatigue hobble CDC’s pandemic response (Politico)
  • Covid Vaccine Pioneers and Others Win 2021 Lasker Awards in Medicine (NYTimes)
  • A Daily Pill to Treat Covid Could Be Just Months Away, Scientists Say (KHN)
  • India's Shilpa Medicare to produce Cadila's COVID-19 shot (Reuters)
  • Vietnam's Vabiotech to start commercial production of Sputnik V vaccine (Reuters)
  • Moderna to supply 20 mln doses of COVID-19 vaccine to Peru (Reuters)
  • Sinovac's COVID shot highly effective against serious illness- Malaysia study (Reuters)
Pharma & Biotech                                                                                                     
  • UK trial to evaluate existing drugs for secondary breast cancer (PharmaTimes)
  • EMA To Coordinate GMP Inspections Via Online Portal (Pink Sheet)
  • AstraZeneca and Merck hope new data can PROpel their PARP inhibitor into first-line prostate cancer (Endpoints)
  • Scott Gottlieb on Covid, a better CDC, and how he does it all (STAT)
  • With Maverick now in Takeda's hands, James Scibetta turns the page; Roivant CMO leaves in favor of small IL-2 biotech (Endpoints)
  • In step forward for rejuvenation field, researchers turn back the clock on mice hearts (Endpoints)
  • Catalent inks deal with Phathom to make GI drug at recently-renovated Kentucky site (Endpoints)
  • UNC researchers report a new way to charge CAR-T against solid tumors (Endpoints)
  • Tillman Gerngross project out of Dartmouth College acquired by Repligen (Endpoints)
  • Lonza unveils new expansion plans at Swiss manufacturing sites, capping off a very busy pandemic (Endpoints)
  • Takeda breaks ground on zero-emission site in Asia; Boston Labs emerges from stealth with mobile cell, gene therapy tech (Endpoints)
  • Microcap gene therapy player says three children suffered serious side effects in PhI/II study (Endpoints)
  • Defense Department watchdog criticizes oversight of military’s pharmaceutical supply chain (STAT)
Medtech                                                                                                                      
  • FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions (MedtechDive)
  • Medtechs facing supply chain disruptions from semiconductor shortage: study (MedtechDive)
  • Boston Scientific CEO: 'Unprecedented' shutdown from delta to hit Q3 (MedtechDive)
  • Ultrasound-analyzing AI improves breast cancer diagnoses by 37%, NYU study finds (Fierce)
  • Lucid Diagnostics prepares to leave the PAVmed nest with $57M IPO filing (Fierce)
Government, Regulatory & Legal
  • Medtronic Beats Back Axonics’ Challenge To InterStim Patents (MedtechInsight)
  • Merck will pay royalties on next-gen pneumococcal shot to settle Pfizer patent fight (Fierce)
  • Gilead, Merck and others slapped with 'pay-for-delay' lawsuits over lucrative HIV and cholesterol meds (Fierce)
  • Insurer Wants 3M To Pay Up For Warming Device Defense (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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