Regulatory Focus™ > News Articles > 2021 > 2 > Recon: EU orders additional 300M doses of Pfizer-BioNTech vaccine; France steps up aid to boost phar

Recon: EU orders additional 300M doses of Pfizer-BioNTech vaccine; France steps up aid to boost pharma manufacturing

Posted 09 February 2021 | By Michael Mezher 

Recon: EU orders additional 300M doses of Pfizer-BioNTech vaccine; France steps up aid to boost pharma manufacturing

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Joe Biden’s big FDA decision (Vox) (Politico)
  • Woodcock vs. Sharfstein: A head-to-head comparison of Biden’s top choices for FDA commissioner (STAT)
  • Eli Lilly says CFO resigns after 'inappropriate communication' with staff (NBC) (Endpoints)
  • Democratic lawmakers push FDA to lift restrictions on abortion pill (Politico)
  • Democrats push temporary Obamacare expansion in Covid bill (Politico)
  • CDC plans national Covid vaccination forum to reassert federal leadership (NBC)
  • An Illegal Dietary Supplement Named Tianeptine Is Being Sold to Americans, and the FDA Knows It (Consumer Reports)
In Focus: International
  • EU finalises second deal with Pfizer for 300 million vaccine doses (Reuters)
  • France Increases Aid for Pharmaceutical Industry in Covid Fight (Bloomberg)
  • Berlin earmarks 9 billion euros to buy COVID-19 shots for Germans and EU (Reuters)
  • India says J&J interested in making COVID-19 vaccine in country (Reuters)
  • WHO expected to back use of Oxford-AstraZeneca vaccine in adults (Reuters)
  • Valneva open to partners for COVID-19 vaccine as it looks beyond Europe (Reuters)
  • Does the world need new COVID vaccines? 'Jury is out', Oxford's Pollard says (Reuters)
  • US joins WHO programme aimed at boosting COVID-19 fight (Reuters 1, 2)
  • Hong Kong biotech sector booms on buoyant markets and pandemic (FT)
  • A move to crack down on human rights, environmental abuses puts European pharma on notice (STAT)
Coronavirus Pandemic
  • WHO team: Coronavirus unlikely to have leaked from Chinese lab (Politico) (NBC) (NYTimes) (NPR)
  • A Few Covid Vaccine Recipients Developed a Rare Blood Disorder (NYTimes)
  • Facebook says it plans to remove posts with false vaccine claims. (NYTimes)
  • Dermapharm aims to start making Pfizer shot at second site by May (WHTC)
  • Japan minister: EU approved first shipment of Pfizer COVID-19 vaccine to Japan (Reuters)
  • India backs AstraZeneca shot despite South Africa halt (Reuters)
  • Pakistan approves Russia's Sputnik-V COVID-19 vaccine for emergency use (Reuters)
  • Sinovac's Ukrainian partner seeks to delay COVID-19 vaccine shipments (Reuters)
  • Hungary to start vaccinations with Russian COVID-19 shot (Reuters)
  • Reference Pricing Clauses In US COVID-19 Contracts Leave Drug Industry Vulnerable (Pink Sheet)
Pharma & Biotech
  • In mid-stage study, KalVista pill halts swelling attacks caused by rare, genetic disease (STAT)
  • BMS finally gets FDA OK for liso-cel, sets $410k launch price (PharmaPhorum)
  • Glaxo’s growth problem (Evaluate)
  • US FDA's Presubmission Expedited Regulatory Programs Eyed For Streamlining (Pink Sheet)
  • We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging (Pink Sheet)
  • US FDA’s Potential Class Of 2021 By The Numbers (Pink Sheet)
  • Lonza offloads specialty ingredients unit in $4.7B sale to Bain Capital, Cinven in consolidation around biopharma (Endpoints)
  • Janssen's esketamine nasal spray gets Europe approval for new indication (Pharmafile)
  • SMC approves funding for four new medicines on the NHS (PharmaTImes)
  • ViiV's HIV drug Rukobia gets EC marketing authorisation (Pharmafile)
  • Freeline Therapeutics slams the brakes on gene therapy trial plans as FDA seeks more clarity on manufacturing (Endpoints)
  • J&J's Erleada/Zytiga combo hits PhIII endpoint — but what about OS?; Targovax loses prostate cancer partner after enrollment struggles (Endpoints)
  • Nautilus set to go public in reverse merger with Perceptive SPAC, aims to test proteomics platform with big-name backers (Endpoints)
  • One of the giant vaccine players pushes back against a ‘fundamental shift’ spurred by mRNA. But is the CEO just whistling past the graveyard? (Endpoints)
  • Months after shocking house arrest, Legend co-founder Frank Zhang is out on bail — though the CAR-T player has moved on (Endpoints)
  • Learning from others' mistakes, low-profile microRNA biotech looks to prove itself in the clinic (Endpoints)
  • Bristol Myers Squibb pulls the curtain on PhIII data to back Opdivo in the adjuvant setting (Endpoints) (Press)
  • BMS and Exelixis’ Opdivo/Cabometyx shows continued benefit in kidney cancer (PMLive)
  • BMS Buoyed By EU Approval Of Myelofibrosis Drug (Scrip) (Press)
  • FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products (FDA)
Medtech
  • Analysts Applaud Zimmer Biomet’s Dental And Spine Spin-Off, Focus On Orthopedics (MedtechInsight)
  • Mightier scores $2M from NIH to study impact of biofeedback video game on children with ADHD (MobiHealthNews)
  • Verily links with Janssen for at-home COVID-19 immune system study (Fierce)
  • Dexcom's first Super Bowl ad sparks social media buzz with celebrity Nick Jonas—and price concerns (Fierce)
Government, Regulatory & Legal
  • 8th Circ. Won't Revive Suit Over Teva's ParaGard Risks (Law360)
  • Whistleblower Gets $3.6M In FCA Deal With Roche, Humana (Law360)
  • Catalent Hit With Patent Suit Over Epilepsy Drug Vimpat (Law360)
  • Novelion Therapeutics Seeks Ch. 15 To Wind Up Liquidation (Law360)
  • MDL Court Predicts Expansion of Illinois Law (Drug & Device Law)
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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