Regulatory Focus™ > News Articles > 2021 > 4 > Recon: Moderna cleared to increase vaccine doses per vial; FDA investigating J&J vaccine mix-up at E

Posted 02 April 2021 | By Michael Mezher 

Recon: Moderna cleared to increase vaccine doses per vial; FDA investigating J&J vaccine mix-up at Emergent facility

2888 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Fauci says US may not need AstraZeneca COVID-19 vaccine (Reuters)
  • FDA allows Moderna to put more coronavirus vaccine doses in each vial (Politico) (Reuters) (FDA)
  • FDA Probes Cause of Failed Johnson & Johnson Covid-19 Vaccine Batch (WSJ)
  • Why the Biden administration might not want to be content with just an acting FDA commissioner (Endpoints)
  • Johnson & Johnson expands COVID vaccine trial to include adolescents (The Hill)
  • FDA Okays New Indication for Alirocumab in Homozygous FH (Medscape) (FDA)
In Focus: International
  • EU countries agree to share 'solidarity vaccines' with states in need (Reuters)
  • EU cuts Austria, Slovenia and Czech Republic from extra vaccine deal (FT)
  • Australia probes if blood clot case linked to AstraZeneca vaccine (Reuters)
  • Netherlands halts use of AstraZeneca vaccine for people under 60 (Reuters)
  • UK regulator found total of 30 cases of blood clot events after AstraZeneca vaccine use (Reuters)
  • China Sinovac says it reached two billion doses annual capacity for COVID-19 vaccine (Reuters)
  • Measles resurgent in Congo eight months after epidemic declared over (Reuters)
Coronavirus Pandemic
  • Trump-Touted Drug Lives On as Covid Therapy Despite Trial Flops (Bloomberg)
  • ‘Where the magic happens’ — inside BioNTech’s innovative vaccine plant (FT)
  • CDC: Vaccinated Americans can now travel (Politico)
  • $1.3 Billion Johnson & Johnson COVID-19 Vaccine Development Contract Contains Broad Redactions Relating to Public’s Rights in Inventions (KEI)
  • Nigeria aims to get 70 million J&J COVID-19 vaccines through African Union (Reuters)
  • India AstraZeneca shot delay could be 'catastrophic' for Africa -health official (Reuters)
  • Backed by Millions in Public and Private Cash, Rapid Covid Tests Are Coming to Stores Near You (KHN)
Pharma & Biotech
  • GlaxoSmithKline offloads royalty rights for 2 cancer drugs in $342M windfall it will use to finance consumer spinoff (Endpoints)
  • Roche/Novartis: rivals play king of the pill (FT)
  • Regeneron shoots for longer Eylea dosing interval in diabetic retinopathy with NIH data (Fierce)
  • Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021 (IPQ)
  • Gilead expands AbCellera antibody discovery pact to access rival to Regeneron's mouse platform (Fierce)
  • Pfizer breaks ground on sterile injectables plant in Michigan, plans to add around 450 jobs to the region (Endpoints)
  • Merck KGaA lands rights to 3rd F-star oncology bispecific antibody (Fierce)
  • Proteomics company SomaLogic to chase $1.2B public valuation through SPAC deal (Fierce)
  • Alloy Therapeutics nabs a $75M series C to sow more seeds into the biotech ecosystem (Fierce)
  • Alcami appoints new CEO in Patrick Walsh, the executive who helped lead the CDMO's predecessor company (Endpoints)
  • It's time: After 19 years, legendary Koch Institute director Tyler Jacks passes the torch to Matthew Vander Heiden (Endpoints)
  • Stuart Lipton offers a new possible reason why all the Alzheimer's drugs have failed (Endpoints)
  • United Therapeutics bags a new OK on Tyvaso, with blockbuster expectations; Gilead goes back to AbCellera's well with a set of fresh targets (Endpoints)
  • After name change and dropped IPO, IN8bio tries again to boost its cancer pipeline (Fierce)
  • FDA cites potential infection risks with reusable urological endoscopes (Fierce) (FDA)
  • Bluestar's blood test nets FDA breakthrough label to screen for pancreatic cancer after sudden cases of diabetes (Fierce)
  • Quest sells minority share of Q2 Solutions for $760M (MedtechDive)
Government, Regulatory & Legal
  • Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition (FDA Law Blog)
  • Mitsubishi Tanabe Wins US Patent Suit on Canagliflozin (PharmaJapan)
  • Vagisil Maker Gets Rival's 'Vagisert' TM Blocked At TTAB (Law360)
  • Big Pharma Tells Justices To Keep Assignor Estoppel (Law360)
  • Illumina Agrees To Delay $8B Grail Deal During FTC Challenge (Law360)
  • Bristol Myers Squibb Settles Medicaid Rebate Suit For $75M (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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