Recon: Moderna begins adolescent study of COVID vaccine; Boehringer scoops up NBE for $1.5B

• FDA advisory panel meets on Pfizer's coronavirus vaccine (Reuters) (STAT)
• Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (NEJM) (Pfizer)
• US plans to ship 2.9 million Covid vaccine doses as early as the end of this week (CNBC)
• Moderna begins study of COVID-19 vaccine in adolescents (Reuters)
• Nesos raises funding for medical device to 'hack' the brain (Reuters)
• J&J says cutting enrollment for COVID-19 vaccine trial by 20,000 as cases rise (Reuters) (STAT)
• AstraZeneca, J&J COVID-19 shots must succeed to meet U.S. vaccination goal: Slaoui (Fierce)
• Trump’s drug-card plan smacks into another roadblock (Politico)
• High Court Says Ark. Law Regulating PBMs Not Preempted (Law360) (STAT)
• Gilead to acquire Germany's MYR GmbH for EUR1.15 billion in cash (MarketWatch)
• Biden’s HHS pick, Becerra, has taken in more campaign cash from health groups than any other industry (STAT)

• What do the UK allergic reaction cases mean for Pfizer's COVID-19 vaccine (Reuters) (MHRA)
• Not without India: World's pharmacy gears up for vaccine race (Reuters)
• Canada prepares to roll out Pfizer/BioNTech vaccine next week (FT)
• India seeks more data for emergency AstraZeneca shot approval (Reuters)
• Boehringer gets into 'guided-missile drugs' with $1.5 billion deal for NBE (Reuters)
• Biogen files for Japan approval for Alzheimer's drug developed with Eisai (Reuters)
• Brazil aims to vaccinate entire population against COVID-19 in 2021 (Reuters)
• Zolgensma Loses Orphan Benefit in Germany After 'Very High Sales' (Pink Sheet)

• Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines (Harvard Bill of Health)
• Opinion - The Risk in Suspending Vaccine Patent Rules (NYTimes)
• LabCorp gets EUA for first at-home collection COVID-19 test with no prescription (MedtechDive)
• US should not wait too long on AstraZeneca vaccine, Oxford's Hill says (Reuters)
• Gates Foundation pledges $250 million more for battle against COVID-19 (Reuters)
• Mexico agrees to buy 35 million doses of Cansino COVID vaccine (Reuters)
• Japan plans vaccine freezer buying binge as Tokyo reports record cases (Reuters)

• Pick the Commish: Voters advance FDA vets, including Gottlieb, Sharfstein and Abernethy, to top-8 showdown (Fierce)
• Special report: Twenty extraordinary women blazing trails in biopharma R&D — Covid-19 and beyond (Endpoints)
• Faze Medicines launches with $81M Series A, Alnylam vet heading science in play at biomolecular condensates (Endpoints)
• NASA-partnered Pluristem crashes to Earth as it axes leading therapy (Fierce)
• NICE authorises Takeda's Alunbrig for ALK-positive advanced non-small cell lung cancer (Pharmafile)
• AbbVie unveils new Phase 3 upadacitinib data in moderate to severe ulcerative colitis (Pharmafile)
• Erectile dysfunction drug packaged with antidepressant in 'product mix-up' (The Hill)
• Lilly reports strong results for next-generation diabetes drug (BioPharmaDive)
• Merck KGaA's MilliporeSigma lays out $47M upgrade for New England sites tapped in pandemic manufacturing push (Fierce)
• SABCS: Merck's Keytruda shows up Roche's Tecentriq with chemo combo win in triple-negative breast cancer (Fierce)
• Trial software firm ERT merges with imaging company Bioclinica; AbCellera bumps IPO range (Endpoints)
• Alkermes CEO Richard Pops wins over activists with a pledge to shake up the company and boost net income (Endpoints)
• Longtime Intercept CEO Mark Pruzanski departs as ailing NASH company tries to find its future (Endpoints)
• Angling for a spot among the giants, TG Therapeutics touts PhIII MS data for CD20 drug (Endpoints)
• Roche yields to cancer biosim competition by offering 'relevant' discounts: report (Fierce)
• Enhertu scores ‘impressive’ new data in HER2 breast cancer (PharmaTimes)
• FDA set to review GSK’s Nucala for nasal polyps (PharmaTimes)
• Pfizer Files Abrocitinib in Japan; 3rd Oral JAK Inhibitor for Atopic Dermatitis (PharmaJapan)
• FDA Will Test Ability to Receive Digital Annotated ECG Waveform Files as Agency Prepares to Transition to New ECG Warehouse (FDA)
• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure (FDA)

• FDA clears Zebra Medical Vision's X-ray modeling AI for orthopedic surgery planning (Fierce)
• Registry finds no link between paclitaxel-coated devices and mortality risk: NEJM (MedtechDive)
• ‘Medtech For Unmet Needs’ Prioritized In New UK Industry Initiative (MedtechInsight)
• UK MHRA Issues More Guidance Ahead Of New Device Regulatory System For 2021 (MedtechInsight)
• Compliance Corner: Being MDSAP-Ready Helpful While FDA Foreign Inspections Paused, Expert Says (MedtechInsight)

• Trump Plan May Set Clock Ticking on Many Health Rules — Setting Off Alarms (KHN)
• House votes to expand marijuana research (Politico)
• Food and Drug Administration Fiscal Year 2020 Performance Review Board (Federal Register)
• Florida finds pharmacy benefit managers are benefiting from a lucrative profit center (STAT)
• FDA Fiddles With Remote Drug Inspections While Pharma Burns (FDA Law Blog)
• New York lawsuit again accuses Martin Shkreli of manipulation from behind bars (Endpoints)
• Mallinckrodt Opioid Claimants Want OK For Info Website (Law360)
• 9th Circ. Revives ACA Claims Over Access To CVS HIV Drugs (Law360)
• Fed. Circ. Judge Skeptical Amgen Cholesterol Drug IP Is Valid (Law360)
• Generics Partner Tells Justices It Can Appeal PTAB Ruling (Law360)
• Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders (Health Canada)
• Guidance on Project Orbis (MHRA)
• Access Generic Medicines Work Sharing Initiative (MHRA)
• Access New Active Substance (NAS) Work Sharing Initiative (MHRA)
• Access Consortium (MHRA)
• Evidence requirements for face masks that are medical devices (TGA)