Recon: WHO’s COVAX scheme at risk; FDA panel backs new use for Novartis’ Entresto

• Top US health official says Pfizer may be facing challenges manufacturing COVID-19 vaccines (Reuters)
• US quarantines Pfizer vaccine shipments in California and Alabama after transit ‘anomaly’ left vials too cold (CNBC)
• US and Pfizer Are Negotiating Deal for More Vaccine Doses Next Year (NYTimes)
• Trump’s $200 Medicare Drug Cards Expected to Be Mailed Jan. 1 (Bloomberg)
• US COVID-19 immunization rollout expands as officials avow vaccine's safety (Reuters)
• Novartis' bid to boost Entresto sales beyond $5 billion gets FDA panel lift (Reuters) (Endpoints)
• BAT's COVID-19 vaccine candidate gets US approval for human trials (Reuters)
• Gilead says not to pursue US approval for rheumatoid arthritis drug (Reuters) (Endpoints)
• Drug Makers Are Pulling Back From a Program to Help the Needy (NYTimes)
• Biden, Pence Make Preparations To Get COVID-19 Vaccine (NPR)

• WHO vaccine scheme risks failure, leaving poor countries no COVID shots until 2024 (Reuters)
• One-quarter of the world may not get a Covid-19 vaccine until 2022, experts warn (STAT)
• EU planning to buy 180 million additional vaccine doses – Spiegel (Reuters)
• Chilean health regulator approves Pfizer/BioNTech vaccine for emergency use (Reuters)
• Valneva to start clinical trials of COVID-19 vaccine candidate in UK (Reuters) (BBC)
• Britain to spend £3.7 billion on vaccines and bear liability, watchdog says (Reuters) (FT)
• Canada inks deal to accelerate deliveries of Moderna vaccine amid second-wave surge (Reuters)
• Fosun Pharma to buy 100M doses of BioNTech's COVID-19 vaccine for mainland China (Reuters) (FT)
• Novo Nordisk to start late-stage trial of semaglutide to treat Alzheimer's (Reuters)

• Covid vaccine: More than 130,000 vaccinated in UK in first week (BBC)
• India may need to spend $1.8 billion on COVID-19 vaccines in first phase, documents show (Reuters)
• Covid-19 Vaccine Trial Volunteers Note Occasional Harsh Side Effects (WSJ)
• Portugal says will have enough COVID-19 jabs for the whole population (Reuters)
• Chinese county preparing to offer coronavirus vaccine to residents (Reuters)
• Roche and Siemens COVID-19 antibody tests shine in FDA accuracy roundup (MedtechDive)

• Biotech IPOs: optimistic prognosis (FT)
• Thermo Fisher aims to boost its clinical offerings with German expansion — including cold chain for the Covid-19 effort (Endpoints)
• They thought their gene therapy failed. Instead, it spawned a medical mystery (Endpoints)
• In a stem cell experiment that seemingly failed, scientists see a possible way to prevent a devastating disease (STAT)
• Lilly eyes up to $2B in COVID-19 sales by year-end—plus revenue boosts in cancer, diabetes and more (Fierce)
• Sage Therapeutics names former Alnylam exec Barry Greene as its new CEO (STAT)
• Novartis gets FDA Breakthrough Therapy tag for experimental iptacopan (Reuters)
• FDA funding study around blood donations from gay men (The Hill)
• Here are the nominees for worst biopharma CEO of 2020 (STAT)
• Beyond The Balance Sheet: Thinking Broadly About Dilution In Building A Transformative Biotech (LifeSciVC)
• NICE recommends Novartis' Beovu for wet age-related macular degeneration (Pharmafile)
• Developing Ways to Measure Safety and Efficacy for Tissue-engineered Products (FDA)
• Samsung Biologics promotes new CEO from within to head next phase of rapid manufacturing expansion (Endpoints)
• After reeling back a gene therapy from Sanofi, a North Carolina upstart bags enough money to do something about it (Endpoints)
• BioAtla heads for Nasdaq on Wednesday following $189M IPO, going public with its pH-detecting cancer treatments (Endpoints)
• Troubled AB Science claims breakout Alzheimer's success while vTv flops — again (Endpoints)
• Updated: Neuron23 launches with $113M financing and eyes dead set on Denali and Biogen (Endpoints)
• Out of CRISPR pioneer David Liu's lab comes a small molecule play targeting exosites — and it's raised a modest $25M to push toward clinic (Endpoints)
• Vivace Therapeutics scores $30M Series C to take oncology candidate for 'Hippo' pathway to human trial next year (Endpoints)
• Sio Gene Therapies posts positive PhI/II data in rare pediatric disease, the first readout since its name change (Endpoints)
• Months into booming acute migraine launch, Biohaven chases prevention with oral CGRP med Nurtec ODT (Endpoints)
• After leaving Wall Street to launch a gene therapy upstart, Rachel McMinn nabs $115M to drive her first candidate to the clinic (Endpoints)

• FDA breakthrough designations go to renal denervation devices in latest batch (MedtechDive)
• Boston Scientific, Nevro agree to nix 1 patent lawsuit, but other legal fights go on (MedtechDive)
• Eudamed: Industry Warned That Additional National Actor Registration Requirements Possible While Database Is Voluntary (MedtechInsight)
• VEO Ophthalmics’ Artificial Iris, Boston Scientific’s Single-Use Duodenoscope Win Pass-Through Payments (MedtechInsight)
• Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers (FDA)
• Medical Device Manufacturer’s Director of Clinical Services Pleads Guilty to Causing the Adulteration of Rectal Pressure Sensors (FDA)

• U.S. HHS to give $4.5 billion more to pandemic-hit healthcare providers (Reuters)
• This Is the Health System That Biden Inherits From Trump (NYTimes)
• Indiana Court Upholds $112M Verdict In Surgeon’s Patent Suit Against Medtronic (MedtechInsight)
• Medical Device Amendments Do Not Preempt Sales Tax (Drug & Device Law)
• Mallinckrodt Stockholders Face Slim Chance Of Ch. 11 Payout (Law360)
• DOJ Opioid Leader Flays Pharmacies In Enforcement Vow (Law360)
• Pa. Sanofi Workers Sue Over Unkept Hazard Pay Pledge (Law360)
• Mylan Tries To Escape Pharmacy's EpiPen Antitrust Suit (Law360)
• Trump's 'Most-Favored Nation' Rule Faces More Lawsuits (Law360)
• Zantac MDL Defendants Argue Claims Are Preempted (Law360)