Regulatory Focus™ > News Articles > 2021 > 3 > Recon: Pfizer says COVID vaccine 100% effective in 12-15 year olds; FTC seeks to block Illumina’s Gr

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Posted 31 March 2021 | By Michael Mezher 

Recon: Pfizer says COVID vaccine 100% effective in 12-15 year olds; FTC seeks to block Illumina’s Grail buyout

2709 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biden faces first Covid surge as allies brush off warnings (Politico)
  • Pfizer COVID-19 vaccine safe, effective on adolescents in trial, companies say (Reuters) (Press)
  • Pfizer to Test Covid-19 Vaccine That Doesn’t Need Ultracold Storage (WSJ)
  • FTC seeks to block Illumina from buying Grail, citing threats to competition (STAT) (FT) (WSJ)
  • How Biden’s infrastructure plan will go after biopharma companies beyond drug pricing (Endpoints)
  • House panel releases new details of Trump administration Covid contracts (Politico)
  • Federal watchdog calls for centralized Covid-19 data website (Politico)
  • FDA advisers reassert case against approval of Biogen's Alzheimer's drug (BioPharmaDive)
  • Amgen takes a swing at regenerative immunology with $721M acquisition of Rodeo Therapeutics (Endpoints)
In Focus: International
 
  • WHO: Risk profile for AstraZeneca COVID vaccine "weighs heavily" in favour (Reuters)
  • EU drug watchdog says no clot risk factor yet linked to AstraZeneca vaccine (Reuters)
  • Sinopharm, Sinovac COVID-19 vaccine data show efficacy: WHO (Reuters)
  • Macron, Merkel discussed potential Sputnik V vaccine cooperation with Putin (Reuters)
  • Pfizer to accelerate COVID-19 vaccine deliveries to Canada, J&J doses due in April (Reuters)
  • Leaders of 23 countries back pandemic treaty idea for future emergencies (Reuters)
  • Ottawa, province to kick in millions to help fund new vaccine manufacturing facility in Toronto (Toronto Star)
Coronavirus Pandemic
  • Getting One Vaccine Is Good. How About Mix-and-Match? (NYTimes)
  • T cells induced by COVID-19 infection respond to new virus variants: U.S. study (Reuters)
  • EU to get 107 million COVID doses by end of March, 30 million from AstraZeneca (Reuters)
  • WHO advises that ivermectin only be used to treat COVID-19 within clinical trials (WHO)
  • Updated requirements for COVID-19 drug authorizations: Notice (Health Canada)
  • Israel plans to give Pfizer's COVID vaccine to adolescents upon FDA approval (Reuters)
  • Austria likely to order Russian Sputnik V vaccine next week, Kurz says (Reuters)
  • Brazil's Fiocruz readies study of AstraZeneca vaccine for minors (Reuters)
  • Covid: Australia falls 85% short of vaccine delivery goal (BBC)
  • US, 13 countries concerned WHO COVID-19 origin study was delayed, lacked access (Reuters)
  • Data withheld from WHO team probing COVID-19 origins in China: Tedros (Reuters)
  • Chinese scientist says Beijing did share COVID-19 data with investigators (Reuters)
  • Russia registers world's first COVID-19 vaccine for animals – watchdog (Reuters)
  • Why Virus Tests at One Elite School Ran Afoul of Regulators (NYTimes)
  • Venezuela receives doses of Russian EpiVacCorona vaccine for trials (Reuters)
  • FDA updates impact of mutations on COVID-19 tests, adds Cepheid to list of affected products (MedtechDive)
Pharma & Biotech
  • The biotech scorecard for the second quarter: 18 stock-moving events to watch (STAT)
  • Most U.S. universities get an ‘F’ on ensuring access to drugs they discover (STAT)
  • Pandemic Perspectives: How COVID May Reshape US Emergency Use Authorizations (Pink Sheet)
  • US FDA’s Rx Drug Promo Study Answers $798,000 Question (Pink Sheet)
  • Work Underway To Demystify Why Regulators Respond Differently To Drug Safety Issues (Pink Sheet)
  • Akebia tries for FDA approval of anemia drug after mixed data (BioPharmaDive)
  • Why do some targeted cancer therapies stop working? For Tyra, that's the $106M question (Endpoints)
  • Move over Boston and San Francisco? Seattle tops list of fastest growing biotech hubs for job opportunities — report (Endpoints)
  • GlaxoSmithKline sells off $155M Zantac plant in India to Hetero Labs for a fraction of its cost (Fierce)
  • Daiichi exits combo vaccine pact with Sanofi after pertussis shot manufacturing glitches (Fierce)
  • Bausch Health sells off Amoun for $740M; Achilles debuts on Nasdaq with $175.5M IPO (Endpoints)
  • Neil Kumar’s BridgeBio team locks in a $2.4B partnership as their next drug gets a snap review at the FDA (Endpoints)
  • Looking to prepare for the next flu pandemic, Sanofi drops $700M+ into new Toronto facility for Fluzone production (Endpoints)
  • EC approves Cabometyx in combination with Opdivo (PharmaLetter)
  • Aurinia’s Dosing Patent For Lupkynis A ‘Slippery Slope’ To Extending US Market Exclusivity? (Pink Sheet)
  • After leaving Merck's C-suite, Mike Nally turns up at the helm of a Flagship machine learning company (Endpoints)
  • Looking to crack down on big biopharma M&A deals, FTC sues to block Illumina's $8B Grail acquisition (Endpoints)
  • Scribe, Jennifer Doudna's newest startup, nabs a mega-round and a vocal investor (Endpoints)
  • A pair of Lyell founders look to shift the cell therapy paradigm — and they've got $30M to get their plan off the ground (Endpoints)
  • Betting early on an AI niche, RA Capital seeds a young founder's quest to unlock 'Holy Grail' targets (Endpoints)
  • Pivoting toward neuromuscular diseases and Duchenne, Entrada locks down $116M crossover round (Endpoints)
  • Nitto Denko lays out $226M to boost oligonucleotide production in a bustling RNA market (Fierce)
  • Takeda Completes Sale of its Japan Consumer Health Care Business Unit to Blackstone (Press)
Medtech
  • ‘Major Milestone:’ FDA Gives CLIA Waiver To Chlamydia, Gonorrhea Test (MedtechInsight)
  • Oxford spinoff receives De Novo clearance for video-based vitals monitoring software (mobihealthnews)
  • A year into the pandemic, advanced cancer diagnoses are rising (MedtechDive)
  • Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts. (MedtechDive)
  • Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave (MedtechInsight)
Government, Regulatory & Legal
  • Generics Cos. Argue For Heritage Bellwether In Antitrust MDL (Law360)
  • Mylan Gets PTAB To Invalidate Sanofi Injector Patent (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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