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Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron

Posted 02 December 2021 | By Michael Mezher 

Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • GSK says tests indicate antibody drug works against Omicron (Reuters) (WSJ)
  • To fight Omicron, Biden to add travel rules, make at-home COVID tests free (Reuters) (STAT)
  • Special Report: US rushed contracts to COVID-19 suppliers with troubled plants (Reuters)
  • AstraZeneca to Scrap Plan for US Covid Booster Study (Bloomberg)
  • BD enters varicose vein treatment market with Venclose buy (Fierce)
  • Democrats, Republicans in US Congress reach deal in government shutdown talks (Reuters)
In Focus: International
  • UK purchases additional 114m coronavirus vaccine doses (FT)
  • UK approves another antibody treatment for Covid (BBC) (MHRA)
  • Covid Omicron: Time to consider mandatory jabs, EU chief says (BBC)
  • EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001) (EMA)
  • WHO says surge team deployed in S.Africa's Gauteng to tackle Omicron (Reuters)
  • Novavax says it could start making Omicron-specific vaccine in January (Reuters)
  • Fujifilm to double size of Teesside plant that makes Covid vaccine (FT)
Coronavirus Pandemic
  • Germany imposes curbs on unvaccinated, to make shots mandatory (Reuters)
  • As Omicron spread looms, oral antivirals appear to be one of the best defenses — now we just need more (Endpoints)
  • US FDA Tags Moderna COVID-19 Vaccine With Higher Myocarditis Risk Than Pfizer/BioNTech (Pink Sheet)
Pharma & Biotech
  • She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy (Pink Sheet)
  • Janssen taps Tempus' AI and real-world data library for cancer drug discovery (Fierce)
  • With only burns to show in gene therapy, Astellas inks deal with AAV specialist Dyno in push for a better capsid (Endpoints)
  • FDA turns down BeyondSpring chemo complication drug, asks for another trial (MedCityNews)
  • Amgen's Otezla notches win in genital psoriasis, snagging possible edge against forthcoming BMS rival (Fierce)
  • Watch out, Roche: Novartis inks $1.5B deal to chase down prominent Parkinson’s target (Endpoints)
  • GlaxoSmithKline, University of Oxford join forces in $40M digital deep dive into neuro (Fierce)
  • Another epigenome editing startup launches from a pair of the field’s longtime leaders (Endpoints)
  • Bob Nelsen woos John Maraganore to his first VC post after retiring from Alnylam (Endpoints)
  • Amgen joins a growing list of drug makers cutting discounts to safety-net hospitals (STAT) (Endpoints)
  • A Seattle biotech offloads lead eye drug in deal valued at $1B+ as it refocuses on emerging pipeline (Endpoints)
  • Can the antibody-drug conjugate model work for NK cells? Acepodia loads up with another $109M to find out (Endpoints)
  • A quiet Czech biotech bags $315M to drive its blossoming cancer pipeline through the clinic (Endpoints)
Medtech
  • Liquid biopsies could help screen for countless cancers. But who should get them? (STAT)
  • Freenome, Siemens join forces to develop blood test for breast cancer (Fierce)
  • US FDA Classifies 5 De Novo-Cleared Device Types (MedtechInsight)
  • FDA Stamps Recall Of Teleflex Percutaneous Thrombolytic Device As Class I (MedtechInsight)
  • IVDR amendment proposal update: moving on up to adoption (MedicalDevicesLegal)
Government, Regulatory & Legal
  • Bristol Myers is sued for refusing COVID-19 vaccine religious exemptions (Reuters)
  • Talc Claimants Seek To Toss J&J Unit's 'Manufactured' Ch. 11 (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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