Recon: Opioid groups campaign against Woodcock as FDA commissioner; EU warns it could block vaccine exports

• Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner (STAT) (Endpoints)
• Pharma distributors in talks with US for cut of COVID-19 vaccine shipping deal (Reuters)
• Pandemic spurs quest to enroll more Black Americans in vaccine trials (Reuters)
• COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention (GAO)
• US drug prices were more than double those in dozens of countries in 2018 (STAT)
• Biden invokes DPA to combat supply shortages, but experts say it's no 'magic wand' (MedtechDive)
• Federal agencies will study Covid vaccine effectiveness on ‘mutant’ strains, Fauci says (CNBC)
• A New Option for Morning-After Contraception? (NYTimes) (NEJM)

• EU warns it could block vaccine exports, wields legal threat at drugmakers (Reuters 1, 2, 3)
• UK vaccine rollout must not be interrupted, minister says of EU demand (Reuters)
• Belgian authorities inspect AstraZeneca pharmacies amid EU vaccine dispute (The Hill) (AP)
• EU now advises three-week interval between Pfizer vaccine doses (Reuters) (EMA)
• UK experts defend 12-week delay for second vaccine dose (FT)
• Pfizer to continue vaccine supply to Italy even if Rome files lawsuit: CEO to paper (Reuters)
• Germany recommends AstraZeneca COVID-19 shot only for under 65s (Reuters) (FT)
• UK says AstraZeneca vaccine works for all age groups despite German concerns (Reuters)
• Japan to source most AstraZeneca vaccines locally amid global snags (Reuters)
• Canada to receive fewer Pfizer vaccine doses than expected in first quarter: media report (Reuters)
• Novartis in talks on helping make COVID-19 vaccines, tests (Reuters)
• Africa secures 400 million more COVID-19 vaccine doses (Reuters)
• WHO says vaccine makers working non-stop to plug supply gap, urges patience (Reuters)
• WHO recommends the dapivirine vaginal ring as a new choice for HIV prevention for women at substantial risk of HIV infection (WHO)

• Racing the virus: Why tweaking the vaccines won't be simple (Reuters)
• Vaccine Shortages Hit E.U. in a Setback for Its Immunization Race (NYTimes)
• How A Lack Of Data On COVID-19 Vaccines Affects Pregnant People (NPR)
• South Carolina identifies the first U.S. cases of coronavirus variant first seen in South Africa (STAT)
• Northern France health agency pushes back date of some first COVID vaccination doses (Reuters)
• Swiss flag possible Moderna COVID-19 vaccine delivery shortfall (Reuters)
• South Korea reviews AstraZeneca vaccine for elderly under rollout plan (Reuters)
• Ukraine parliament votes to speed up vaccine registrations (Reuters)
• Delivery delays force Portugal to extend first phase of vaccinations (Reuters)
• WHO team in Wuhan probing COVID-19 origins moves out of quarantine (Reuters)
• China health authority and WHO discuss cooperation for coronavirus origin investigation (Reuters)
• South Africa Allows Use of Parasite Drug in Covid Patients (Bloomberg)
• Life Biotech Pty Ltd fined $106,560 for alleged non-compliance with requests for information and face mask samples in relation to COVID-19 (TGA)

• ARCH raises $1.85 billion fund, planning to back more big companies (STAT)
• Pharma is only ‘inching forward’ in boosting access to medicines in low-income countries (STAT)
• Top gene therapy deals, M&A pacts in 2020 highlight another big year in one of the hottest fields in biopharma (Endpoints)
• IPO Year In Review: Record-Year Bodes Well For 2021, And For More SPACs (Scrip)
• Chinese Firm Hit With Pandemic's First Remote-Records-Based FDA Drug GMP Warning Letter (Pink Sheet)
• AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs (Fierce)
• Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development (IPQ)
• Bayer and AskBio expand grand gene therapy ambitions with new Parkinson's program, top scientist (Endpoints)
• Dean Li kicks off Merck's post-Roger Perlmutter era by teaming with Artiva and its off-the-shelf CAR-NK tech (Endpoints)
• Yescarta Becomes Japan’s Second Approved CAR-T (Pink Sheet)
• BeiGene's PD-1 scores PhIII win in esophageal cancer — a 'key indication' tapped by Novartis in $650M deal (Endpoints)
• Medigene cuts TCR-T therapy in pivot to focus on solid tumors (Endpoints)
• Moment Of Truth In EU For Amarin’s ‘Multi-Billion-Dollar Opportunity’ Drug (Pink Sheet)
• Evotec Subsidiary Expands mAb Contract with the U.S. DOD (GEN)
• Lilly attempts to revive an old idea for tackling pain, licensing PhI program from Japan’s Asahi Kasei Pharma (Endpoints)
• Takeda earns win for its TKI inhibitor in tiny lung cancer group — but GI side effects could be an early red flag (Endpoints)
• Thermo Fisher platform seeks to expedite donor cell cultivation for allogeneic cell therapies (Endpoints)
• One of the most ambitious startup teams in biotech just outlined plans for a $400M IPO and a valuation of about $4B (Endpoints)
• Agios strengthens the case for mitapivat (Evaluate)
• MHLW Official Urges Pref. Govts to Implement Thorough Inspection, Guidance for Drug Makers after Kobayashi Kako Fiasco (PharmaJapan)
• IDIA and the WHO announce strategic collaboration to support the scale-up of health innovations (WHO)
• WHO issues new guidelines on the management of chronic pain in children (WHO)
• WHO announces updated definitions of extensively drug-resistant tuberculosis (WHO)
• WHO highlights progress in accelerating access to hepatitis C diagnostics and treatment in low- and middle-income countries (WHO)

• Common Regulatory Starting Point Means EU-UK Are On Track For Medtech MRA, Say German Firms (MedtechInsight)
• Richard Branson-backed Spac in talks to merge with 23andMe (FT)
• Edwards' US TAVR sales fall as COVID-19 disrupts referral process (MedtechDive)
• Abbott Q4 beat driven by COVID-19 test demand, devices come in flat (MedtechDive)
• England's NHS moves to boost access to Quidel, Roche, other medtech products (MedtechDive)

• Biden to reopen online health insurance marketplaces (Reuters)
• Biden takes first step toward bolstering Obamacare (Politico)
• Biden starts rolling back Trump anti-abortion rules (Politico)
• Medtech Industry Favorite Wins Seat On Powerful House E&C Committee (MedtechInsight)
• PTAB Weighs Novelty Of Bio-Rad DNA Microfluidics Techs (Law360)