Regulatory Focus™ > News Articles > 2021 > 4 > Recon: J&J discards 15M vaccine doses after mix-up at Emergent facility; GAO finds US doesn’t have p

Posted 01 April 2021 | By Michael Mezher 

Recon: J&J discards 15M vaccine doses after mix-up at Emergent facility; GAO finds US doesn’t have patent rights to remdesivir

3147 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson (NYTimes)
  • Company producing J&J vaccine had history of violations (AP)
  • White House knew more than a week ago of J&J contractor vaccine-supply problems (Politico)
  • An Accidental Disclosure Exposes a $1 Billion Tax Fight With Bristol Myers (NYTimes) (Endpoints)
  • Pfizer shot 91% effective in updated data, protective against South African variant (Reuters)
  • US begins testing Moderna’s Covid vaccine booster shots for variant from South Africa (CNBC)
  • US okays Abbott's rapid COVID-19 test for at-home screenings in those without symptoms (Reuters) (The Hill) (FDA)
  • The US government doesn’t have patent rights to Gilead’s remdesivir, despite investing millions in research (STAT) (Endpoints) (GAO)
  • FDA advisers tear apart case for Biogen's Alzheimer's drug aducanumab ahead of final decision (Fierce) (Endpoints) (JAMA)
In Focus: International
  • EU seeks 10 million AstraZeneca vaccines from India to meet shortfall (Reuters)
  • Pfizer Warns EU Bureaucracy Is Holding Back Worldwide Vaccine Efforts (Barron’s)
  • Japan to get first batches of AstraZeneca COVID-19 vaccine from US (Reuters)
  • Brazil health regulator approves emergency use of Johnson & Johnson COVID-19 vaccine (Reuters)
  • J&J says South African health regulator registers its COVID-19 vaccine (Reuters)
  • At BGI, China’s genomics giant, the line between biotech and Beijing is increasingly blurry (STAT)
Coronavirus Pandemic
  • China's TopRidge Pharma to produce Sputnik V vaccine, Russia's RDIF says (Reuters)
  • WHO's Kluge says European COVID-19 vaccine campaign is 'unacceptably slow' (Reuters)
  • Poland's Mabion aims to produce Novavax vaccine for Europe from third quarter (Reuters)
  • South Korea pays price for reliance on COVAX, scrambles for vaccines (Reuters)
  • Brazil detects new coronavirus variant similar to South African (Reuters)
  • Japan Trials Get Underway for AstraZeneca’s COVID-19 Antibody Therapy (PharmaJapan)
Pharma & Biotech
  • A ‘Game Changer’ for Patients With Esophageal Cancer (NYTimes)
  • More trials to get back on track in U.S. and U.K. as vaccine rollout dampens COVID threats: Report (Fierce)
  • Major Review Of EU Pharmaceutical Legislation Kicks Off (Pink Sheet)
  • Gilead’s Trodelvy To Test UK Innovative Drug Pathway (Pink Sheet)
  • Celgene Files Its 2nd CAR-T Therapy Ide-Cel in Japan: BMS (PharmaJapan)
  • Data for Delcath’s liver tumor device are positive, but lingering questions cloud path to approval (STAT)
  • Sanofi keeps nipping at J&J's heels as Sarclisa notches new FDA approval in multiple myeloma (Endpoints) (Press)
  • Apotex yanks ADHD med after traces of schizophrenia drug turn up in a single lot (Fierce)
  • Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease (FDA)
  • NICE recommends Sobi’s Kineret for first-line use in Still’s disease (PharmaTimes)
  • EC grants marketing authorisation to Angelini Pharma’s epilepsy treatment (Pharmafile)
  • Genentech aims high with new diversity goals, including doubling hires and spending $1B with diverse suppliers (Fierce)
  • UK risking a cancer research black hole as government cuts science budgets, charity donations in freefall (Fierce)
  • Cutting loose from Merck, Mike Nally is 'running toward a great opportunity'; Novartis partnership in hand, BeiGene promotes Julia Wang to CFO (Endpoints)
  • India notifies first policy on rare diseases (Economic Times)
  • TCR² plants its flag in former Autolus manufacturing site, planning to add 175 jobs as it advances lead T cell therapy (Endpoints)
  • Piramal Pharma Solutions picks up Indian peptide API maker in push into oncology, metabolic contract work (Endpoints)
  • Takeda Completes Sale of Four Diabetes Products in Japan to Teijin Pharma Limited (Press)
  • The Factors Undoing EU Regulatory Harmonization As MDR/IVDR Wait In Wings (MedtechInsight)
  • FDA clears contactless, camera-based system for monitoring vital signs (Fierce)
  • Zimmer Biomet bundles robotic surgery, apps and digital health programs into one orthopedics package (Fierce)
  • FDA links certain breast reconstruction devices to risk of complications (MedtechDive) (FDA)
  • Bioventus acquires devicemaker Bioness in $110M deal to pursue COVID-19's 'new normal' (Fierce)
Government, Regulatory & Legal
  • New Prescription Drug Price Transparency Law in Virginia (FDA Law Blog)
  • KEI Comments on NIH Exclusive License to Ridgeback for FDA-approved Ebola Treatment (KEI)
  • Proposed Amendments To Bayh-Dole Regulations Are Vexing (Law360)
  • Distributors Can't Duck Nuisance Claim Ahead Of Opioid Trial (Law360)
  • Oldest Opioid Suit, An MDL Bellwether, Evades Latest Assault (Law360)
  • Drug Price Checker Can Move Ahead With Antitrust Suit (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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