Regulatory Focus™ > News Articles > 2021 > 2 > Recon: Pfizer asks FDA to okay storing vaccine at higher temps; J&J seeks WHO emergency listing for

Recon: Pfizer asks FDA to okay storing vaccine at higher temps; J&J seeks WHO emergency listing for COVID vaccine

Posted 19 February 2021 | By Michael Mezher 

Recon: Pfizer asks FDA to okay storing vaccine at higher temps; J&J seeks WHO emergency listing for COVID vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer wants to store vaccine at higher temperatures, making distribution easier (Reuters)
  • Pfizer plans to test COVID-19 vaccine booster targeting the South African variant (Reuters)
  • CDC data on first month of vaccinations find Pfizer-BioNTech, Moderna shots safe to use (Reuters)
  • Biden to visit Pfizer factory as Americans clamor for more COVID-19 vaccine supply (Reuters)
  • Tensions start to emerge in Biden’s dance with governors (Politico)
  • Short of Vaccine, States Find Hidden Stashes in Their Own Backyards (NYTimes)
  • Biologics Face Tougher Patent Scrutiny After Amgen Ruling (Law360)
  • AbbVie puts an end to Botox trade secrets suit, imposes royalty, license deal on competitor Evolus (Endpoints) (Press)
In Focus: International
  • Johnson & Johnson applies to WHO for emergency use listing of COVID-19 vaccine (Reuters)
  • Confusion over Russia's EU vaccine approval bid could be result of misdirected application (Reuters)
  • Germany to set up vaccine task force to boost production (Reuters)
  • AstraZeneca/Oxford vaccine more effective with longer dose gap: study (Reuters)
  • Israeli studies find Pfizer COVID-19 vaccine reduces transmission (Reuters)
  • Rich nations stockpiling a billion more COVID-19 shots than needed: report (Reuters)
  • Individual vaccine arrangements undermine fair distribution, WHO head says (Reuters)
  • Congo confirms two new Ebola cases, including one far from centre of outbreak (Reuters)
  • UK plans to launch $1.1 billion ‘high-risk, high-reward’ science research agency (CNBC) (UK.GOV)
Coronavirus Pandemic
  • G7 leaders put spotlight on vaccine donations to developing world (FT)
  • Biden To Announce $4 Billion For Global COVID-19 Vaccine Effort (NPR)
  • US and Novavax Will Aid Global Vaccination Campaign (NYTimes)
  • US will not send vaccines to developing countries until supply improves (FT)
  • Germany pledges additional 1.5 billion euros for COVAX and WHO (Reuters)
  • EU doubles contribution to COVAX with over $600 million in new funding (Reuters)
  • UK PM Boris Johnson to call on G-7 support for 100-day target to develop new vaccines (CNBC)
  • African Union says Russia offers 300 million doses of Sputnik V vaccine (Reuters)
  • Delays Turn Canada’s Vaccination Optimism Into Anxiety (NYTimes)
  • Dr.Reddy's seeks Indian emergency use authorization for Russia's Sputnik V vaccine (Reuters)
  • South Africa leads backlash against big pharma over Covid vaccine access (The Guardian)
  • South Africa advisers back Pfizer COVID-19 vaccine after study (Reuters)
  • Brazil health ministry says plans to order 30 million more Coronavac doses (Reuters)
  • New Zealand vaccinators receive COVID-19 jab ahead of formal rollout (Reuters)
  • Notice to manufacturers, importers and distributors: Research use only for COVID-19 tests (Health Canada)
Pharma & Biotech
  • Investment firm raises $300M to fund medical research for overlooked diseases (BioPharmaDive)
  • ‘A massive gap in information’: Most vaccine clinical trials fail to report data on participants’ ethnicity or race (STAT)
  • To get ahead of variants, Covid-19 drug makers use evolutionary biology as a guide (STAT)
  • Mallinckrodt becomes the latest victim of the FDA's pandemic-related delays as it pushes off application for skin graft (Endpoints)
  • Japan Pricing Environment ‘Highly Unpredictable’: PhRMA (Pink Sheet) (PharmaJapan)
  • Precision's one-time gene editing treatment lowers cholesterol in monkeys for 3 years (Fierce)
  • Avacta gets MHRA green-light to start phase I trial for ‘pro-drug’ chemotherapy (PharmaTimes)
  • Waiting for Big Pharma’s Coronavirus Profits to Impress Wall Street (WSJ)
  • Bluebird’s Zynteglo safety snag could spell trouble for other gene therapies: analysts (Fierce)
  • The SPAC boom continues to churn out heavy capital, as Foresite prices its $175M blank check company and 2 others file (Endpoints)
  • The Quality Lowdown: Yes, The US FDA Expects You To Heed Import Alerts And Testing Requirements (Pink Sheet)
  • Endpoints Manufacturing: 5 Questions with Homology Medicines (Endpoints)
  • Astellas scores a pair of trial wins for menopausal hot flash med, raising the pitch of looming Bayer standoff (Endpoints)
  • Old-hat investors Alta Partners snag $275M for their newest next-gen fund, more than double the first iteration from 2018 (Endpoints)
  • Lannett Announces New Co-development Agreement for Biosimilar Insulin Aspart (Big Molecule Watch)
  • Glaxo’s Supplier Plans Pakistan’s Largest Pharma IPO (Bloomberg)
  • Oregon's Cascade Chemistry looks to boost its American-made API production with $14M investment (Endpoints)
  • After crossing t's, dotting i's, Immunocore nails down breakthrough therapy designation for lead TCR therapy (Endpoints)
  • EMA Shifts Gear On Patient Feedback During Drug Review (Pink Sheet)
Medtech
  • FDA’s Shuren: Staff Overburdened, Review Times Seeing Negative Effects (MedtechInsight)
  • Quidel mulls entering new COVID-19 testing markets after another bumper quarter (MedtechInsight)
  • FDA Panel Votes No On BD's Balloon For Below The Knee (MedtechInsight) (MedtechDive)
  • FDA Inspections All But Stopped In 2020 – But Quality-Related Warning Letters Kept On Coming (MedtechInsight)
  • Building Trust through Transparency? FDA Regulation of AI/ML-Based Software (Harvard Bill of Health)
Government, Regulatory & Legal
  • Federal judge nixes hospitals’ attempt to force HHS 340B crackdown (STAT)
  • How The Pandemic Is Shaping Patent Trials In District Courts (Law360)
  • Fed. Circ. Says PTAB Wrongly Upheld Cancer Detection Patent (Law360)
  • Drug Database Provider Wins Challenge To OTC Label Change (Law360)
  • Bayer's $650M PCB Deal Hits Snag Over Extra Funds Window (Law360)
  • Mallinckrodt Says Competitor Unlawfully Recruited Employees (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.

Tags: US, worldwide

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