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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)