Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

• US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies (Pink Sheet)
• Experts Warn U.S. Could See New Coronavirus Hot Spots (NPR)
• Biden says 65% of people 65 or older have received at least one COVID vaccine shot (Reuters)
• Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary (Endpoints)
• New HHS Secretary Becerra urged to expand digital health access (Healthcare IT News)
• J&J’s MS drug ponesimod receives approval in the US (PMLive)
• When states should reopen, briefly explained (Vox)
• FDA spells out how the Covid-19 variants impact the effectiveness of Regeneron, Eli Lilly mAb treatments (Endpoints)
• Fauci Denounces Sen. Paul’s ‘Dead Wrong’ Anti-Mask Message As Studies Show Variants Still Pose A Threat (Forbes)

• Not Enough Vaccine Doses In Europe To Stop A 3rd Wave, German Health Minister Says (NPR)
• Charts show that Europe’s third coronavirus wave has begun (CNBC)
• The EU Vaccine Bungling (Marginal Revolution)
• Europe aims to get vaccinations back on track after clearing AstraZeneca shot (Reuters)
• Oxford vaccine chief says reassuring that safety monitoring systems are working (Reuters)
• Australia relieved after EU drug regulator backs AstraZeneca vaccine (Reuters)
• France limits AstraZeneca Covid jab to over-55s as Europe treads cautiously (Guardian)
• Health Canada follows European regulators in backing AstraZeneca's COVID-19 vaccine (Reuters)
• RDIF & Stelis Biopharma to supply 200 million doses of the Sputnik V vaccine (Pharmafile)
• EU to back vaccine export checks when leaders meet next week: draft decision (Reuters)
• Pelmeg developed with aid of regulatory reform (GaBI)
• Plans For Mandatory EU Joint Clinical Assessments Watered Down (Pink Sheet)

• Will try to supply more doses of COVID-19 vaccine to UK later: Serum Institute (Economic Times)
• U.S. Will Send 4 Million AstraZeneca Vaccine Doses to Canada and Mexico (FDA News)
• The 'Tamiflu' Approach to Treating COVID-19 (MedPage Today)
• Germany could imagine signing deal for Sputnik V shot, minister says (Reuters)
• Keep using AstraZeneca vaccine, WHO urges world (Reuters)
• Providing Cancer Care in the Age of COVID-19 (Harvard Law)
• The Case for Donating US Covid Vaccines Overseas (KHN)

• SEC charges co-founders of shuttered microbiome startup uBiome with $60 million fraud (STAT)
• Merck, Eisai detail Keytruda and Lenvima's endometrial cancer win in confirmatory study (Fierce Pharma)
• Sanofi parts ways with Oxford BioMedica on hemophilia tie-up inked by Bioverativ (Fierce Pharma)
• NICE recommends new triple therapy for multiple myeloma patients (Pharmafile)
• Merck breathes a sigh of relief as Keytruda-Lenvima combo aces confirmatory study in endometrial cancer (Endpoints)
• Three drugmakers nab $639M as biotech's IPO pace eclipses a record year (BioPharma Dive)
• Microbiome biotherapeutic shows promise in acute graft-versus-host disease (EPR)
• Jakafi failed the primary endpoint in a Covid-19 study. But Incyte is still going to FDA with a compassionate use pitch (Endpoints)
• Two Rare Disease Biotechs Rake in $170 Million in Public Equity Offerings (Global Genes)
• How Five Prime suitor Amgen battled multiple companies for the biotech—and won (Fierce Biotech)
• NICE approves Lynparza plus Avastin via Cancer Drugs Fund (PharmaTimes)
• Idera's TLR9 drug flunks melanoma phase 3, tanking stock (Fierce Biotech)
• IVM releases toolbox on how to switch patients to insulin biosimilars (GaBI)
• Antibiotic stewardship may be improving at U.S. hospitals, but new targets are still needed (STAT)
• Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development (IPQ)
• How Amgen spent $2 billion on a biotech that had been on the brink (Endpoints)
• Gilead and Novo Nordisk advance NASH collaboration to larger clinical study (MedCity News)
• Knowledge and perceptions about naming biosimilars in the US (GaBI)
• The state of play for copy biologicals in China (GaBI)
• Takeda bags mRNA translation modulators in $120M Anima deal (Fierce Biotech)
• Starving tumors to slow melanoma and pancreatic cancer (Fierce Biotech)
• FDA approves first treatment for recurrent pericarditis (PharmaLetter)
• Cancer immunotherapy may also treat certain autoimmune diseases (EurekAlert)
• How RNA editing affects the immune system (EurekAlert)

• Novel blood cleansing device to enter first-in-human trial (EPR)
• New Image Sensor Aims to Make a Difference in Surgical and Diagnostic Endoscopy (MD+DI)
• Like an artificial nervous system (EurekAlert)
• More stroke patients receiving mechanical clot removal, yet racial disparities persist (EurekAlert)
• Medline Expands UV Disinfection Portfolio (PR Newswire)
• Scientists identify genetic pathway that suppresses Lou Gehrig's Disease (EurekAlert)

• What Will “Modernizing” Regulatory Review Look Like? (AAF)
• Democrats unveil bill to prevent Sackler family from evading lawsuits through bankruptcy (The Hill)