Recon: Merck stops development of COVID vaccines; Moderna developing booster against new COVID variants

• Merck ends COVID vaccine program, cites inferior immune responses (Reuters) (Endpoints) (STAT)
• Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses (NYTimes) (Politico)
• US goal to squeeze more COVID shots from Pfizer vials hampered by syringe production (Reuters)
• Moderna says it believes vaccine will work against new variants (Reuters) (STAT) (NYTimes)
• Moderna making booster shot to fight Covid-19 variants (Politico)
• CVS completes first round of COVID-19 vaccination at 8,000 U.S. nursing homes (Reuters)
• U.S. Senate aims to pass COVID-19 bill ahead of Trump trial (Reuters)
• U.S. CDC says 21.8 million doses of COVID-19 vaccines administered (Reuters)
• Pfizer says its Covid vaccine trial for kids ages 12 to 15 is fully enrolled (CNBC)
• CDC quietly changes Covid vaccine guidance to OK mixing Pfizer and Moderna shots in ‘exceptional situations’ (CNBC)
• Biden health officials express concern about short-term vaccine supply crunch (Politico)
• Biden Team Promises New Look in Trade Policy (WSJ)
• FDA approves 1st long-acting HIV drug combo, monthly shots (NBC)
• Aurinia secures FDA drug approval for autoimmune kidney disease, with label offering stronger patent protection (STAT) (Endpoints)

• Australia approves Pfizer vaccine, warns of limited global AstraZeneca supply (Reuters) (TGA)
• AstraZeneca to supply 31M COVID shots to EU in first quarter, a 60% cut - EU source (Reuters)
• European Ombudsman probes failure to disclose Covid-19 vaccine contracts (STAT)
• EU urges AstraZeneca to speed up vaccine deliveries amid 'supply shock' (Reuters)
• EU to force pharmaceutical companies to fulfill Covid-19 vaccine contracts (France24)
• Germany expects EU approval for AstraZeneca COVID-19 vaccine on Friday (Reuters)
• EU to require advance registration of COVID-19 vaccine exports (Reuters)
• Italy to take legal action on COVID vaccine delays to get doses (Reuters)
• Germany to administer Covid drugs used to treat Donald Trump (The Guardian)
• WHO panel to issue recommendations on Moderna vaccine next week (Reuters)
• Pfizer wants India to order COVID-19 vaccine before pursuing approval (Reuters)
• Tata in talks to launch Moderna COVID-19 vaccine in India (Reuters)
• India to give homegrown vaccine in seven more states this week (Reuters)
• Turkish competition watchdog fines Novartis, Roche units (Daily Sabah)

• How U.S. CDC missed chances to spot COVID's silent spread (Reuters)
• Fauci: U.K. coronavirus variant leads to worse infections (Politico)
• Mexico's president says he's tested positive for Covid (Politico)
• No serious adverse events in Covaxin Phase 1 trials (Economic Times)
• From factory to faraway village: behind India's mammoth vaccination drive (Reuters)
• Morocco gets 2 million AstraZeneca vaccine doses, first big shipment to Africa (Reuters)
• A gout drug shows promise for Covid-19, but skeptics worry about trusting science by press release (STAT)
• FDA rolls back N95 mask reuse to 4 decontamination cycles (Fierce)
• AdvaMed: Medtech Industry Wants Seat At Biden’s Coronavirus Response Table (MedtechInsight)
• French health body recommends delaying second COVID shot to six weeks after first (Reuters)
• Pfizer requests South Korea approval COVID-19 vaccines ahead of February rollout (Reuters)
• Pakistan to approve Russian Sputnik COVID-19 vaccine for emergency use (Reuters)
• Bahrain approves Oxford-AstraZeneca COVID vaccine for emergency use (Reuters)
• Hong Kong formally approves Fosun Pharma-BioNTech vaccine (Reuters)
• Mali picks AstraZeneca COVID-19 vaccine for 4.2 million people (Reuters)
• Poland says Moderna delays COVID-19 vaccine supply (Reuters)
• Turkey receives 6.5 million doses of China's Sinovac vaccine: media (Reuters)

• Opinion: The stakes for choosing the right FDA commissioner couldn’t be higher (STAT)
• Civica Rx lays out $124M sterile injectables plant, pegged to supply COVID-19 drugs and more (Fierce)
• IPO tracker: 2021 gets started with a flurry of new offerings (Endpoints)
• Biotech firm ‘victim of kickback fraud’ (The Times)
• Bristol Myers Squibb's MS newcomer Zeposia gets the thumbs-down from England's price police (Fierce)
• Cognate beefs up cell, gene therapy manufacturing with new plants in U.S., EU (Fierce)
• Merck KGaA's cancer drug Bavencio gets EU approval (Pharmafile)
• Calquence tops Imbruvica in chronic lymphocytic leukaemia study (PharmaTimes)
• Global Regulators Issue Advice On Clinical Comparability Of Biosimilar MAbs (Pink Sheet)
• Pricing challenge looms for Novartis as cholesterol drug's US fate remains unclear (BioPharmaDive)
• Vivek Ramaswamy and Matt Gline pen shareholder letters about the changes now underway at Roivant (Endpoints)
• Roche amps up its bispecific attack on Eylea with more PhIII data — but just how threatening is it? (Endpoints)
• Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain (Pink Sheet)
• Albireo just advanced down to the 10-yard line at the FDA. And Ron Cooper’s team is getting prepped for the next big play (Endpoints)
• Lonza looking to build on 'differentiated advantage' in Covid-19, CDMO marketplace in 2021 (Endpoints)
• Buried in Immunocore's IPO filings? A kickback scheme from a now former employee (Endpoints)
• Can struggling Iterum turn the corner to an antibiotic success story? They will know in six months (Endpoints)
• Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA (FDA)

• Finally remote initial audits, or not (yet)? (medicaldeviceslegal)
• Alphabet's Verily bets on long-term payoff from virus-testing deals (Reuters)
• Abbott, Edwards focus on mitral valve as market projected to rival TAVR (MedtechDive)
• Intuitive braces for bumpy 2021 as COVID-19 resurgence hits robotics (MedtechDive)
• FDA clears J&J's robotic surgery system for total knee replacements (Fierce)
• FDA approves Boston Scientific's newest deep brain stimulator for Parkinson's disease (Fierce)
• Boston Scientific Bets Big On Monitoring; Buys Preventice For Up To $1.25Bn (MedtechInsight)
• TGA carves out exemptions for some software-based medical devices (Emergo)

• Leadership and FDA Appropriation for FY 22 (Alliance for a Stronger FDA)
• Alliance for a Stronger FDA
• PhRMA sues to block Trump administration 340B rule (STAT)
• US, Smith & Nephew Tell Justices PTAB Is Constitutional (Law360)
• ITC To Probe Chinese Co. After Kan. AG Warns Of IP Theft (Law360)
• Former Insys Execs Win 7th Virus-Induced Prison Delay (Law360)
• Ensuring predictability for exceptionally imported health products: Notice to industry (Health Canada)