Recon: FDA releases hundreds of pages of Trump-era emails; Biogen gene therapy misses study goals

• Internal Trump-era emails reveal a plethora of celebs, companies vying for FDA’s attention (Endpoints) (Politico) (FDA)
• Biogen's experimental eye treatment fails to meet study goal (Reuters) (Endpoints)
• Fully vaccinated people can shed their masks in most places - CDC (Reuters) (STAT)
• Adolescents Can Get Routine Immunizations With Their COVID Shots, CDC Advisers Say (NPR)
• US diplomats: Send vaccine overseas now or China, Russia will win out (Politico)
• Charles River loses a battle over harvesting horseshoe crabs used for testing bacteria in drugs (STAT)

• WHO urges rich countries to donate shots instead of vaccinating children (Reuters)
• India's Dr. Reddy's to get 36 mln doses of Sputnik V vaccine in next few months (Reuters)
• Big promises, few doses: why Russia’s struggling to make Sputnik V doses (Reuters)
• J&J pushes Latin America to take unfrozen vaccines in Covax talks (FT)
• Chinese firm's COVID-19 drug claims draw skepticism (Reuters)
• Samsung says decision pending on making Moderna vaccine as report ignites share (Reuters)

• Delayed second Pfizer COVID-19 shot produces more antibodies -study (Reuters)
• COVID-19 lab leak theory cannot be ruled out, leading scientists say (Reuters)
• BARDA slows its $9B engine for new Covid-19 therapeutics (Endpoints)
• 'Unacceptable': Only 7 percent of vaccinated Florida residents are Black (Politico)
• Latinos Are the Most Eager to Get Vaccinated, Survey Shows — But Face Obstacles (KHN)
• Chugai Presses on with Japan Development of 3 COVID-19 Drugs, Aims for Antibody Cocktail Filing in 2021: President (PharmaJapan)

• US FDA Preparing For Potential Bolus Of Complex Generic Applications (Pink Sheet)
• AbbVie's Rinvoq needs steep discount in eczema, cost watchdog ICER says (Fierce)
• Pfizer publishes clinical trial diversity data from past decade, showing there's much work to be done (Endpoints)
• CF Foundation backs a new round for a biotech upstart out to rival the mighty Vertex (Endpoints)
• Gene therapy player turned kidney specialist Vera drops a dud in leadup to Nasdaq, pricing well below range (Endpoints)
• Vaccine maker Northwest Bio claims it's in the homestretch for its manufacturing expansion in the UK (Endpoints)
• After going down different drug discovery paths, Genentech vets reunite at Foresite Labs to map the 'protein interactome' (Endpoints)
• Lupin Pursues India Approval For Lucentis Biosimilar, COVID-19 Opportunities (Scrip)
• NICE nod for BMS’ Opdivo in advanced oesophageal cancer (PharmaTimes)
• PerkinElmer hits the checkbook again, this time doling out $260M for next-gen therapy bioservices firm (Endpoints)
• Remove barriers restricting the research of controlled drugs, says RPS (PharmaTimes)
• NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis (PharmaPhorum)
• Larkspur Health Acquisition files to go public as this year's SPAC flood surges over $14B (Endpoints)
• As Codiak enters 'next phase of growth,' Jennifer Wheler steps into CMO role; Mark Timney lines up his second CEO opportunity after Purdue Pharma reign (Endpoints)
• Kinase inhibitor specialist Kinnate launches Shanghai subsidiary with $35M to market its programs in China (Endpoints)
• Kept an ocean away from its scientific advisors, Shanghai's Elpiscience keeps up the clinical progress, refuels for its I/O pipeline (Endpoints)
• Scynexis takes out $60M loan ahead of expected approval; Compass Therapeutics acquires new bispecific antibody in buyout (Endpoints)

• Open The Champagne! EU Go Ahead For Standards Needed For New Medtech Regulations (MedtechInsight)
• Success Of Case For Quality Program Triggers ‘Culture Shift’ At FDA's Device Center, Officials Say (MedtechInsight)
• EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems (medtechdive)
• Cell phone, smartwatch magnets may disturb pacemakers, other implanted devices: FDA (medtechdive) (FDA)
• Abbott (formally known as “St. Jude Medical”) Recalls Assurity and Endurity Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life (FDA)

• Moderna's Appeal Based On 'Imagined' Error, Fed. Circ. Told (Law360)
• UCB Can't Halt Drug Ingredient Import In Vimpat IP Case (Law360)