The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > 2021 > 9 > Recon: US to invest $3B in COVID vaccine supply chain; EU ends dispute with AstraZeneca over vaccine

Recon: US to invest $3B in COVID vaccine supply chain; EU ends dispute with AstraZeneca over vaccine deliveries

Posted 03 September 2021 | By Michael Mezher 

Recon: US to invest $3B in COVID vaccine supply chain; EU ends dispute with AstraZeneca over vaccine deliveries

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

In Focus: US
  • US to invest $3 bln in COVID-19 vaccine supply chain -White House official (Reuters)
  • Health Officials Advise White House to Scale Back Booster Plan for Now (NYTimes)
  • FDA retirements reignite debate over Biden booster plan (The Hill)
  • Analysis: Are COVID boosters needed? FDA vaccine advisers wrestle with a thorny issue (Reuters)
  • FDA nod for Janssen schizophrenia treatment Invega Hafyera (PMLive)
  • Older job seekers claim that Lilly favors millennials when it comes to hiring sales reps (STAT)
  • The Purdue bankruptcy plan was approved. Will it get derailed by appeals? (STAT)
  • Novartis halts study of iscalimab in kidney transplant patients (Reuters)
In Focus: International
  • EU ends dispute with AstraZeneca over vaccine deliveries (FT) (BBC) (Reuters)
  • EU to Return Millions of Doses of J&J’s Covid-19 Vaccine Imported From Africa (WSJ)
  • EU reviewing risk of rare inflammation after COVID-19 vaccinations (Reuters) (EMA)
  • China faces difficulties in expanding COVID-19 vaccination drive, official says (Reuters)
Coronavirus Pandemic
  • Arkansas inmates say they weren't told they were treated for COVID-19 with ivermectin (The Hill)
  • Abbott, Quest, Quidel scramble to add test capacity as delta variant surges (MedtechDive)
  • Moderna's booster plan comes into focus with pre-print studies in immunocompromised populations, Delta breakthroughs (Endpoints)
  • U.S. shipping more coronavirus vaccines to African countries (Reuters)
  • Lilly's COVID-19 antibody combo cleared for nationwide use as feds say it can tackle the dominant delta variant (Fierce)
  • India gives Biological E nod to study its COVID-19 vaccine in children, teens (Reuters)
  • Philippines approves emergency use of Moderna's COVID-19 vaccine for 12-17 year olds (Reuters)
Pharma & Biotech
  • Drug-resistant infections have increased in hospitals during the pandemic. (NYTimes)
  • Meet Neffy, the friendly epinephrine nasal spray from ARS Pharma awaiting FDA approval (Fierce)
  • Pfizer, marking fast research pace, starts key trial of RSV vaccine (BioPharmaDive)
  • The long-overlooked safety issue weighing on the FDA’s mind on day 1 of marathon gene therapy meeting (Endpoints)
  • With approval for China's 2nd CAR-T therapy, Juno, WuXi joint venture goes up against Gilead and Fosun's Yescarta (Fierce) (Endpoints)
  • As bankruptcy neared, workers at a USAntibiotics site worked until the lights went out. Now, the site will get a second life (Endpoints)
  • Bristol Myers licenses for Evotec molecule for $20M; FDA approves Impel's migraine nasal spray Trudhesa (Endpoints)
  • Hot off of a $210M Series B, Umoja breaks ground in Colorado on CAR-T site (Endpoints)
  • Cassava CEO goes on the offensive over data allegations, shouting down 'short attack' (Endpoints)
  • Forte Biosciences shares collapse after lead bacteria drug flops key eczema study (Endpoints)
  • EMA Lays Out Plans For Routine Use Of Real-World Evidence (Pink Sheet)
  • NICE recommends Novartis’ Cosentyx for children with severe psoriasis (PharmaTimes)
  • GDUFA III Talks Completed; Fees will Fund Inspection, Complex Generic Improvements (Pink Sheet)
  • Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases (Pink Sheet)
  • AstraZeneca’s Ultomiris approved for use on children in EU (Pharmafile)
  • EU To Tighten Up Some Pharmacovigilance Requirements (Pink Sheet)
Medtech
  • ECRI CEO calls on FDA, industry to revisit COVID-19 medical device EUAs as shortages ebb (MedtechDive)
  • Abbott gets its blood pumping by acquiring clot-removing devicemaker Walk Vascular (Fierce)
  • QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg (MedtechInsight)
  • Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits (FDA)
Government, Regulatory & Legal
  • Theranos founder Elizabeth Holmes will face jury of seven men and five women in fraud trial (CNBC)
  • United States Obtains $140 Million in False Claims Act Judgments Against South Carolina Pain Management Clinics, Drug Testing Laboratories and a Substance Abuse Counseling Center (DOJ)
  • Florida Man Pleads Guilty to Conspiracy to Defraud FDA in Connection with Dietary Supplements (DOJ)
  • Former East Tennessee Clinic Owner Convicted of Unlawful Opioid Distribution (DOJ)
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.

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe