Recon: Switzerland to start vaccinating after authorizing Pfizer vaccine; FDA declines to approve Novartis cholesterol drug

• CDC Panel Endorses Moderna Vaccine for Americans (NYTimes)
• Frontline Workers and People Over 74 Should Get Shots Next, CDC Panel Says (NYTimes)
• FDA declines approval of Novartis' cholesterol-lowering drug (Reuters) (Press)
• COVID-19 vaccination drive heads to nursing homes (Reuters)
• House panel subpoenas HHS, CDC leaders over COVID-19 response (Reuters)
• Biden to receive coronavirus vaccine on Monday as U.S. inoculation effort mounts (Reuters)
• Sacklers cited fear of OxyContin lawsuits before transferring $10B from their company (Reuters) (STAT)
• AstraZeneca's Tagrisso gets broader US FDA nod for lung cancer (Reuters)
• Top U.S. health official says third COVID-19 vaccine could come next month (Reuters)
• Warp Speed official takes blame for overcount of Covid shot allocations (Politico) (STAT)

• EU clears Pfizer COVID-19 vaccine for first inoculations (Reuters)
• EU agreed 15.50 euros per dose for Pfizer vaccine -document (Reuters)
• Swiss to start Pfizer COVID-19 vaccine jabs after watchdog's OK (Reuters)
• WHO sees limited rollout of Pfizer vaccine by end-January (Reuters)
• UK has given COVID shots to 500,000, Johnson says (Reuters)
• China CanSinoBIO's COVID-19 vaccine trials recruit over 20,000 people (Reuters)
• China starts work on plant for mRNA-based COVID-19 vaccine candidate – media (Reuters)
• Inside J&J's Latam COVID vaccine trial, a rush to recruit is followed by disappointment (Reuters)
• Japan govt board: data on efficacy of COVID-19 drug candidate Avigan is inconclusive (Reuters)
• Nestle wins European Commission approval for peanut allergy drug Palforzia (Reuters)
• Agios sells cancer business to French drug maker for up to $2 billion, will now focus on inherited diseases (STAT)
• UK to expedite drug trials post-Brexit (Reuters) (FT)

• Experimental Drugs Aim to Treat Long-Haul Covid Patients (WSJ)
• CDC issues guidelines on COVID-19 vaccination after allergic reactions (Reuters)
• WHO says no need for major alarm over new coronavirus strain (Reuters)
• EU executive asked to set guidelines on Britain travel curbs (Reuters)
• Britain faces isolation as world tightens borders to keep out new coronavirus strain (Reuters)
• Health Care Workers Still Face Daunting Shortages of Masks and Other P.P.E. (NYTimes)
• Anxiety clouds China’s rush to vaccinate parts of the world (FT)
• Singapore gets Asia's first batch of Pfizer's COVID-19 vaccine (Reuters)
• Qatar, Oman to receive Pfizer-BioNTech COVID-19 vaccine this week (Reuters)
• Pharmacies’ starring role in vaccine push could create unequal access (Politico)
• Canada regulator expects to complete Moderna COVID-19 vaccine approval in coming weeks (Reuters)
• Colombia to receive 1.7 million doses of Pfizer/BioNTech vaccine in February (Reuters)
• Brazil state should receive 10.8 million doses of Coronavac vaccine by Dec 31, governor says (Reuters)
• AstraZeneca, Russia's Sputnik V developer to sign cooperation memorandum -Kremlin (Reuters)
• Belarus registers Sputnik V vaccine, in first outside Russia (Reuters)
• Belarus to start vaccinating citizens with Russia's Sputnik V in January (Reuters)
• Kazakhstan has started production of Russia's Sputnik V vaccine (Reuters)
• Beckman Coulter plans $4, high-volume COVID-19 antigen test (Fierce)

• Sosei, GSK agree to develop inflammatory bowel disease treatment (Reuters)
• GlaxoSmithKline Says ViiV First Long-Acting HIV Regimen Approved In EU (Reuters)
• Roche says faricimab meets goals in trial against rivals' Eylea (Reuters)
• Uniqure’s hemophilia B gene therapy program on hold due to cancer diagnosis in treated patient (STAT)
• Shionogi's novel antibiotic selected for UK pilot subscription reimbursement model (Pharmafile)
• In groundbreaking move, FDA approves Myovant's relugolix as the first once-a-day pill for advanced prostate cancer (Endpoints) (FDA)
• FDA approves selinexor for refractory or relapsed multiple myeloma (FDA)
• Best-selling Tagrisso further outpaces an upcoming J&J rival, winning approval in new NSCLC indication (Endpoints) (FDA)
• AstraZeneca, FibroGen's roxadustat hits snag at FDA, but analysts figure an approval's still on its way (Fierce)
• Another Divestment By Takeda, To China’s Hasten For $322m (Scrip)
• Nitrosamine Testing Policy From European Pharmacopeia’ Largely Aligns With USP (Pink Sheet)
• Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials; Public Meeting (FDA)
• Colorectal drug candidates focal point of new collaboration between Servier, Celsius Therapeutics (Endpoints)
• Patrick Soon-Shiong merges troubled 'moon shot' NantKwest and cell therapy play ImmunityBio in late-stage expansion (Endpoints)
• Following a quick approval in AML, Astellas' Xospata flops in chemo combo for frontline patients (Endpoints)
• Months after striking SHP2 deal with AbbVie, Jacobio pulls in $174M+ from Hong Kong IPO (Endpoints)

• FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations (FDA)
• CEO of Medical Device Company Charged in COVID-19 Related Securities Fraud Scheme (DOJ)
• Notified bodies warn MDR certification bottleneck could lead to medical device shortages (MedtechDive)
• Medtronic, GE, Philips embrace AI amid regulatory limbo around algorithms (MedtechDive)
• Philips buys U.S. cardiac care company BioTelemetry in $2.8 billion deal (CNBC)

• A former FDA chief, brimming with experience but lacking in niceties, surprises Washington by winning Biden’s trust (STAT)
• Biotech CEO Charged With Pushing Fake Fast COVID-19 Test (Law360)
• Full Fed. Circ. Won't Take Up Biogen Appeal Over MS Drug (Law360)
• Bayer, MSN Labs Seek To Drop Drug IP Fight Midtrial (Law360)
• Pfizer Faces 1st Damages Trial In 2021 Over Axed Lyrica IP (Law360)
• Insurer Lost Millions In Regeneron Drug Scheme, Suit Says (Law360)
• 3rd Circ. Seeks NJ High Court Input In Pelvic Mesh Fees Fight (Law360)
• No Preemption In Blood Pressure Drug Contamination MDL (Law360)
• Federal Circuit Affirms PTAB Finding that Rituxan® Biogen Patent is Invalid (Big Molecule Watch)