Recon: Genfit spikes its NASH drug; Jakafi nearer to GVHD approval

• US Surpasses 4 Million Known Coronavirus Infections (NYT)
• White House executive office cafeteria closed after positive coronavirus test (CNBC)
• Covid-19 Vaccine Pricing Will Impact Big Pharma’s Reputation (Forbes)
• Trump’s electoral longshot: A vaccine by October (Politico)
• Pfizer, BioNTech's U.S. supply deal price tag leaves room for 'decent' profit on COVID-19 shot: analyst (FiercePharma) (The Hill)
• No Hanky-Panky at HHS's New COVID Data Hub, Contractor Says (MedPage Today)
• Quick pivot to new HHS COVID-19 reporting rules meant 'chaos' for hospitals (Healthcare IT News)

• Commission still talking to vax companies, while U.S., U.K. secure deals (Politico)
• UK spends £100m on new Covid-19 vaccine facility (Financial Times)
• PM Modi seeks US investment in India’s healthcare sector (Pharmaletter)
• European pharma will 'continue to lose ground to other regions' if Brexit agreement isn't right (Pharmaletter)
• MHRA Prepares For Safe Return To On-Site Inspections In UK (Pink Sheet)
• WHO slams ‘unacceptable’ remarks by U.S. Secretary of State Mike Pompeo (CNBC) (KFF)
• WHO warns there’s no going back to ‘old normal’ as coronavirus accelerates in three countries (CNBC)
• UK MHRA announces two Class 2 medicine recalls (European Pharmaceutical Review)
• Vertex and NHS Wales agree on Kaftrio reimbursement (PharmaTimes)

• The U.S. Commits to Buying Millions of Vaccine Doses. Why That’s Unusual. (NYT)
• Coronavirus measures lead to lower influenza numbers across the Southern Hemisphere (The Hill)
• Favipiravir has limited efficacy data, but doctors still go for Glenmark’s drug to cope with a crisis (Economic Times)
• Access Bio gets FDA emergency authorization for quick Covid-19 test (MedCity News)
• NIH leadership details unprecedented initiative to ramp up testing technologies for COVID-19 (NIH)
• Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19 (FDA)
• These charts show coronavirus cases are accelerating in some parts of Asia Pacific (CNBC)
• Coronavirus vaccines speed ahead, but experts fear not everyone will take them (BioPharmaDive)
• EMA to monitor real world use of COVID-19 treatments and vaccines (European Pharmaceutical Review)
• Florida hospital ICUs near capacity as COVID-19 cases remain high (CBS)
• Beyond Antibodies: Study Examines Cellular Immune Responses in COVID-19 (MedPage Today)
• Study: IL-7 May Help Severe COVID-19 Patients (MedPage Today)
• California Surpasses New York In Total COVID-19 Cases (NPR)
• Can Masks Save Us From More Lockdowns? Here's What The Science Says (NPR)
• As Long Waits for Results Render COVID Tests ‘Useless,’ States Seek Workarounds (KHN)

• Novartis, Regeneron wage acrimonious patent fight over Eylea's prefilled syringe (FiercePharma)
• End of the line for Genfit's experimental NASH drug (PharmaTimes) (FierceBiotech)
• Jakafi closer to nabbing new GVHD approval (Pharmaletter)
• ICER Determines OCA’s Benefit In NASH Might Support Limited Approval (Scrip)
• Synthesis and Analysis Advancements Are Unleashing the Potential of Peptides and Oligos, Spurring CMC Regulatory Dialogue (IPQ)
• Gilead continued equity stake strategy with $300M deal (BioPharma-reporter.com)
• Biotech
• Borisy's EQRx bags rights to EGFR inhibitor to drive discount me-too plan (FierceBiotech)
• Roche drops hep B antiviral as late-stage pipeline tests 'largely on track' despite COVID-19 disruption (FierceBiotech)

• Medical Device “Certificates of Compliance,” “Attestations of Conformity” have no legal standing under MDR (MHRA)
• Boston Sci Wins Nod for Next Gen Watchman Device (MD+DI)
• Debyser gains CE mark for NGS hereditary breast and ovarian cancer test (GenomeWeb)
• Favorable PhIII data for Roche’s Port Delivery System with ranibizumab for neovascular ARMD (Roche)
• QUIBIM secures €8M for radiology AI platform that detects COVID-19 (MobiHealthNews)
• Neurovalens raises £5M for clinical trials of its neurostimulation tech (MobiHealthNews)
• ‘It’s Like Groundhog Day’: Coronavirus Testing Labs Again Lack Key Supplies (NYT)

• The EU Court’s Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required (Medicaldeviceslegal)
• HCA posts a billion-dollar profit, bolstered by CARES Act funds (MedCity News)
• Purdue Pharma’s Legal Fees Mount Amid Calls for Probe Into Drugmaker (WSJ)