Recon: EU reaches deals for additional Pfizer, Moderna shots; Medtronic recalls unused Valiant Navion stents

• Insiders at Covid-19 Vaccine Makers Sold Nearly $500 Million of Stock Last Year (WSJ)
• After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency review staff (STAT) (Endpoints)
• Biden Administration Says It Has Increased Vaccine Supply (NPR)
• Biden admin rushes to close virus-sequencing gap as variants spread (Politico)
• FDA approves expanded use of Novartis heart drug (Reuters) (Press)
• Bristol Myers, Sanofi To Appeal $834M Hawaii Order On Plavix (Law360)

• EU Clinches More Vaccine Deals After Underwhelming Rollout (Bloomberg) (AP)
• Pfizer's COVID-19 vaccine supply to the EU 30% below plans, sources say (Reuters)
• EU books 150 million extra Moderna COVID-19 vaccines for 2021, option for more in 2022 (Reuters) (Politico)
• EU says AstraZeneca COVID-19 vaccine production capacity in Belgium has sharply increased (Reuters)
• Trials test the efficacy of Oxford-AstraZeneca vaccine on children (BBC)
• EU prepares research funding boost as it confronts virus variants (FT) (EC 1, 2)
• Medtronic recalls unused heart stents after patient dies in clinical trial (Reuters) (Press)
• In first for the world, Britain OKs challenge trial exposing volunteers to COVID-19 (Reuters)
• GSK, Vir Biotech to expand COVID-19 research partnership for other diseases (Reuters) (Endpoints)
• Novartis and Bill & Melinda Gates Foundation collaborate on therapy for sickle cell disease (Reuters)
• U.N. chief calls for global vaccination plan, urges G20 to lead effort (Reuters)

• Shortage of giant plastic bags threatens global vaccines rollout (FT)
• Russia’s Covid vaccine faces global production hurdles (FT)
• Technology Executive Apologizes After Dozens of Event Attendees Contract Covid-19 (NYTimes)
• Row over Zydus vaccine trials as Noida seals illegal lab (ET)
• India's COVID-19 'human barricade' to keep cases under control, say experts (Reuters)
• Japan begins COVID-19 vaccination in 'first major step' to halt pandemic (Reuters)
• South Korea's vaccine goals 'practically impossible', medical body's chief says (Reuters)
• Taiwan says BioNTech vaccine deal on hold, cites potential Chinese pressure (Reuters)
• The myth of ‘good’ and ‘bad’ Covid vaccines: Why false perceptions overlook facts, and could breed resentment (STAT)
• Pharma Mar to trial Aplidin on hospitalised UK COVID patients (Reuters)
• Gaza gets its first COVID-19 vaccine shipment, officials say (Reuters)

• Cancer cases place Bluebird Bio’s gene therapy business at a crossroads, and might drag the entire field along (STAT)
• Enhertu Nabs A First With UK Approval Under EU ‘Reliance Route’ (Pink Sheet)
• G1's Cosela scores FDA nod to ease chemotherapy's harmful effects on bone marrow (Fierce)
• Ultra-rare but not forgotten: New drug development paradigms to treat the rarest of diseases (STAT)
• Complexity Has Benefits: Data Show Biologics, Targeted Agents Have Better Approval Prospects (Scrip)
• Moving up the lines, AstraZeneca stakes another PhIII win for Lynparza as adjuvant breast cancer therapy (Endpoints)
• 75 jobs to go with closure of AbbVie plant in Galway (RTE)
• After four decades, one researcher's radical HIV cure finally gets its shot (Endpoints)
• Lilly Undeterred By UK NICE Funding Blow For Second-Line Use Of Verzenios (Pink Sheet)
• Sanofi Backs Novadiscovery In Silico Trial Platform (Scrip)
• Eli Lilly adds new board member Kimberly Johnson, the COO who helped lead Fannie Mae out of the US housing crisis (Endpoints)
• Stephen Elledge's Harvard lab takes $17M to birth ImmuneID, a high-throughput antibody startup (Endpoints)
• Pfizer chips in on $26M raise for rheumatoid arthritis collaborator; Hansoh licenses an anti-fungal for a mysterious infection (Endpoints)
• Pioneering regenerative med scientist Laura Niklason takes her company public in the latest big SPAC deal. And that gives her a shot at making biotech history (Endpoints)
• Weeks after dropping big response data, Amgen lines up priority review for KRAS hopeful sotorasib in NSCLC (Endpoints)
• Gene editing expert Charlie Albright tells us why he hopped from Editas to a new role as CSO of an upstart biotech out to engineer gene therapy 2.0 (Endpoints)
• Nektar, stung by new investor lawsuit over IL-2 drug, secures $150M for Keytruda combo pivotal trial (Endpoints)
• FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (Press)
• PFIZER INITIATES PIVOTAL PHASE 2 MAGNETISMM-3 TRIAL OF BCMA-CD3 BISPECIFIC ANTIBODY ELRANATAMAB (PF-06863135) IN MULTIPLE MYELOMA (Press)
• Tirzepatide significantly reduced A1C and body weight in people with type 2 diabetes in two phase 3 trials from Lilly's SURPASS program (Press)

• Commission ‘Must Act’ Over Uncertain Virtual Audit Situation As Threat Looms Over MDR Certificates (MedtechInsight)
• Italy’s ISS Becomes 19th Notified Body To Be Designated Under MDR (MedtechInsight)
• Securing FDA Approval For Novel OPRA Prosthetic Wasn’t A ‘Slam Dunk.’ Here’s How Start-Up Integrum Made It Through The PMA Maze (MedtechInsight)
• Market Intel: Rivalry Among Insulin Pump Makers Heats Up With Expected Launches In 2021 (MedtechInsight)
• FDA Experts To Convene For March Panel To Discuss Dermal Fillers (MedtechInsight)
• February 17, 2021: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)

• Owner of Sport Supplement Company Sentenced for Unlawful Distribution of Steroid-Like Drugs (DoJ)
• BMS Accuses Teva Of Infringing Eliquis Blood Thinner Patent (Law360)
• Biomet Seeks Judgment, New Trial In $3.5M Implant Suit (Law360)
• Fed. Circ. Won't Revive Generics' Bid To Ax Takeda Patent (Law360)
• Parents Ask Judge To Rethink Cert. Denial For 'Opioid Babies' (Law360)
• McKinsey's Opioid Woes Far From Over Despite $600M Deals (Law360)