Regulatory Focus™ > News Articles > 2021 > 2 > Recon: China approves Sinovac vaccine for general public; Pfizer expects to speed vaccine production

Recon: China approves Sinovac vaccine for general public; Pfizer expects to speed vaccine production

Posted 08 February 2021 | By Michael Mezher 

Recon: China approves Sinovac vaccine for general public; Pfizer expects to speed vaccine production

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase (USA Today) (Fierce)
  • Fauci looking ahead to more vaccines in March, April (Politico)
  • Virus Variant First Found in Britain Now Spreading Rapidly in US (NYTimes)
  • White House says it is working to speed early production of J&J COVID-19 vaccine (Reuters)
  • Biden’s vaccine ad campaign hits roadblock: Not enough doses (Politico)
  • Dueling endorsements emerge for FDA commissioner: Woodcock or Sharfstein? (STAT) (Pink Sheet)
  • States Pressure Drugmakers After McKinsey’s $600 Million Opioid Settlement (WSJ)
  • FDA approves Bristol-Myers' gene therapy for white blood cell cancer (Reuters) (Endpoints)
  • TG Therapeutics scores conditional FDA go-ahead for a drug it's pitching as a safer PI3K (Endpoints)
In Focus: International
  • Governments support AstraZeneca shot after South Africa halts roll-out (Reuters) (FT)
  • South Africa looks to J&J vaccine after disappointing AstraZeneca data (Reuters)
  • Germany talking to BioNTech about funding for vaccine capacity (Reuters)
  • WTO is urged to ease trade rules so low-income countries can access drugs and vaccines (STAT)
  • COVAX bottlenecks need to be urgently addressed, U.N. agency says (Reuters)
  • Vaccine diplomacy: India seeks to rival China with broad shipments (Reuters)
  • China approves Sinovac Biotech COVID-19 vaccine for general public use (Reuters 1, 2)
  • Italian DNA-based COVID-19 vaccine candidate could start clinical trials in March – developer (Reuters)
  • New Ebola Outbreak Threatens in Congo (NYTimes) (The Hill)
  • International regulators working together to enhance collaboration on COVID-19 observational research (EMAv)
Coronavirus Pandemic
  • Biden says challenging for U.S. to reach herd immunity by summer's end (Reuters)
  • Biden administration deploys more than 1,000 active-duty troops to aid vaccination efforts (Politico)
  • White House Is Lining Up 6 More Contracts To Boost At-Home Coronavirus Tests (NPR)
  • FDA alerts health care professionals and compounders of potential risks associated with the compounding of remdesivir drug products (FDA)
  • Russian Campaign Promotes Homegrown Vaccine and Undercuts Rivals (NYTimes)
  • CanSino vaccine seeks emergency approval in Mexico: foreign minister (Reuters)
  • Pfizer applies to register COVID-19 vaccine in Brazil (Reuters)
  • Brazil drugmaker seeks contract, regulatory OK for Russian vaccine next week (Reuters)
  • Relief Therapeutics says data from COVID drug trial to emerge this month (Reuters)
  • Italy's regulator approves conditional use of COVID-19 antibody therapies (Reuters)
  • Czech health ministry recommends use of Lilly and Regeneron COVID-19 antibody therapies (Reuters)
  • U.S. lawmakers say Trump appointees interfered with COVID-19 testing guidance (Reuters)
  • Texas Republican first in U.S. Congress to die from COVID-19 (Reuters)
  • CanSinoBIO's COVID-19 vaccine 65.7% effective in global trials, Pakistan official says (Reuters)
  • A 'home-grown' Covid-19 vaccine deal is near, says Biovac CEO (Sunday Times)
Pharma & Biotech
  • How a scientific journal’s ‘grotesque overreaction’ inflamed the contentious debate over Biogen’s Alzheimer’s drug (STAT)
  • FDA blasts Keytruda data for new breast cancer indication as ‘questionable, immature, and unreliable’ (STAT) (Pink Sheet)
  • WHO announces updated critical concentrations for susceptibility testing to rifampicin (WHO)
  • Freeline Therapeutics slams the brakes on gene therapy trial plans as FDA seeks more clarity on manufacturing (Endpoints)
  • Seqens majority owner looking to sell API maker amid record-high run in healthcare valuations: report (Endpoints)
  • Editas names new CEO in latest executive shakeup (BioPharmaDive)
  • Regeneron stumbles in PhI Libtayo combo study as safety concerns force suspension (Endpoints)
  • Jasper's cell therapy conditioning agent shows promise in small study; ViiV's Rukobia sees approval in Europe (Endpoints)
  • A synthetic lethality player emerges in China, armed with lessons on undruggable oncogene from Nobel laureate's lab (Endpoints)
  • Two years after investor panic, Avrobio touts 100% response as they look to chart a path toward approval (Endpoints)
  • Deerfield and Dana-Farber forge closer ties to launch a new translational cancer research engine (Endpoints)
  • 'Can't say no': Kite Pharma taps Frank Neumann as new head of clinical development (Endpoints)
  • Ex-Biogen CEO Jim Mullen steps back to the helm of a biotech, and once again he has a critical challenge to confront (Endpoints)
  • Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukemia (Press)
  • FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients (Press)
Medtech
  • Medtech earnings season continues to show COVID-19 uncertainty (MedtechDive)
  • Zimmer takes electives hit in Q4, to spin off spine, dental units (MedtechDive)
  • FDA OKs Signifier neurostim device for snoring, sleep apnea (MedtechDivev) (FDA)
  • Orthopedic therapy developer Bioventus returns with 2nd IPO, totaling $125M (Fierce)
  • GE Healthcare hands off molecular breast imaging assets to newcomer SmartBreast (Fierce)
  • Hologic taps Google Cloud for AI-driven cervical cancer screening collaboration (Fierce)
  • Medicare DME competitive bidding in doubt after failed round: analysts (MedtechDive)
  • QA/RA Outlook 2021: 4 Hotspots To Watch, From ‘Hybrid’ US FDA Inspections To QSR Harmonization (MedtechInsight)
Government, Regulatory & Legal
  • Wyden to wield new power on health care, taxes with committee gavel (The Hill)
  • Republicans seek to pin California’s Covid-19 problem on Biden’s HHS pick (Politico)
  • Former Galena chief Mark Ahn back in hot water as DOJ levels insider trading charges for consultant work (Endpoints)
  • 9th Circ. Won't Revive Breast Implant Suits Against J&J Unit (Law360)
  • J&J Wins Settlement In Counterfeit Device Row (Law360)
  • 5th Circ. Won't Revive Claims Tying Generic Drugs To Disease (Law360)
  • Astellas Gets Scientists Cut From Stem Cell Patent After Trial (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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