Recon: UK could approve Pfizer-BioNTech vaccine within days; Biogen bets $1.5B on Sage depression drug

• Moderna to seek US and EU authorization for its vaccine on Monday (Reuters) (NYTimes)
• Two coronavirus vaccines available in US in coming weeks: health secretary (Reuters)
• Novavax sees start of US COVID-19 vaccine trial in coming weeks after second delay (Reuters)
• In major bet, Biogen pays $1.5 billion for rights to a once-failed treatment for depression (STAT) (BioPharmaDive)
• Divisions emerge among US officials over when first Covid-19 vaccine doses will be available — and for whom (STAT)
• Governments around the world weigh thorny question: Who gets the vaccine first (Politico)
• DeepMind solves 50-year-old ‘grand challenge’ with protein folding A.I. (CNBC) (NYTimes)
• McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses (NYTimes)
• Several weeks after getting hit with an RTF, Y-mAbs lands approval for its other neuroblastoma candidate (Endpoints) (FDA)
• Biden’s other health crisis: A resurgent drug epidemic (Politico)

• UK set to approve Pfizer-BioNTech Covid vaccine within days (FT)
• Health Canada could approve first Covid-19 vaccine in December (Politico)
• Statement on continuation of vaccine trials (ICMRA)
• Canada blocks bulk exports of some prescription drugs in response to Trump import plan (Reuters) (NPR)
• Russia begins mass trials of second coronavirus vaccine (Reuters)
• Russian hospital says it began civilian coronavirus vaccinations last week (Reuters)
• UK secures two million more doses of Moderna's COVID-19 vaccine (Reuters)
• MPs raise concerns over vaccine supply after Pfizer shuts cold storage site (The Times)
• Novavax Gains After U.K. Vaccine Study Fully Enrolled (Bloomberg)
• Suspected North Korean hackers targeted COVID vaccine maker AstraZeneca (Reuters)
• China’s vaccines may have ‘appeal’ in developing countries, economist says (CNBC)
• Brussels issues €60m fine over drug price fixing (FT)
• Reckitt Benckiser files £1bn claim against former subsidiary Indivior (FT)

• The Virus Won’t Stop Evolving When the Vaccine Arrives (NYTimes)
• Military’s Role in Vaccine Will Be Strictly Behind the Scenes, Despite Trump’s Claims (NYTimes)
• How Pharma Money Colors Operation Warp Speed’s Quest to Defeat COVID (KHN)
• Trump officials hold first ‘Operation Warp Speed’ briefing for Biden (Politico)
• A COVID-19 Vaccine For Children May Still Be Many Months Away (NPR)
• AstraZeneca CEO Soriot plans new study to test that controversial 90% efficacy figure, waiting for US data before going to FDA (Endpoints)
• American Airlines conducts trials to transport COVID-19 vaccine (Reuters)
• COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document (MedtechInsight)
• Meeting of the EU scientific advice platform on COVID-19 Meeting Report (EC)
• Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators (FDA)

• ‘How are we going to get on that plane?’: The transatlantic race to deliver CAR-T cancer therapy during the pandemic (STAT)
• US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows (Pink Sheet)
• ‘Most Favored Nation’ Pricing Data May Be Long-Term Impact Of Last-Minute Rule (Pink Sheet)
• Trump Administration Slaps Pharma Industry with International Reference Pricing Rule (But will it Survive?) (FDA Law Blog)
• ‘Legacy’ Drugs And Former US FDA Commissioner Gottlieb’s Legacy (Pink Sheet)
• New Guidelines Cover Opioid Use After Children’s Surgery (NYTimes)
• FDA gives Rhythm the green light for setmelanotide, a drug aimed at reducing obesity in certain genetic disorders (Endpoints)
• News Briefing: Four biotechs announce IPO terms, setting the pace to round out a busy year; FDA sets PDUFA date for Kadmon's graft-versus-host drug (Endpoints)
• Kinaset launches with $40M and a JAK inhibitor from Vectura's old pipeline (Endpoints)
• Shopping for a holiday pipeline gift? How about an anti-NGF antibody from Astellas? (Endpoints)
• FDA offers ‘breakthrough’ status for a HER2xHER2 bispecific at the top of Zymeworks’ pipeline (Endpoints)
• Ziopharm and a minority investor spent Thanksgiving fighting over control of the company as activist attack continues to unfold (Endpoints)
• MHLW Approves Label Expansions for Forxiga, Trelegy, Evrenzo, Cabometyx and More (PharmaJapan)
• Japan to Set New Generic Target by March-End: Health Minister (PharmaJapan)
• ICH to Stick to Urgent Topics with Significant Impact for Now amid COVID-19 (PharmaJapan)
• Press release ICH Assembly virtual meeting, November 2020 (ICH)

• Medtronic ends earnings season with mixed results vs. TAVR rival Edwards (MedtechDive)
• FDA approves device for treatment of osteoid osteoma in the extremities (FDA)
• IVDR notified body count inches up to 5 with TÜV Rheinland designation (MedtechInsight)
• ‘Ready For Day 1’ – UK MHRA’s Statement Of Intent For Post-Brexit Medtech Regulatory System (MedtechInsight)
• NHS to pilot Grail's cancer-spotting blood test in 165,000 patients (Fierce)
• Personalised medical devices (including 3D-printed devices) (TGA)

• TwIqbal in Third Circuit “Parallel Claim” Preemption Cases (Drug & Device Law)
• Par Pharmaceutical, Inc. v. Hospira, Inc. (Fed. Cir. 2020) (Patent Docs)