Recon: US buys another 100M doses of Pfizer-BioNTech vaccine; AstraZeneca submits vaccine data to MHRA

• Pfizer, US strike 100 million COVID-19 vaccine deal with 70 million due by June (Reuters) (Press)
• US vaccine rollout's next challenge: Verifying who is 'essential' (Reuters)
• Supernus drug meets main goal of study in adults with ADHD (Reuters) (Endpoints)
• FDA slaps a hold on Voyager's lead gene therapy over 'MRI abnormalities' (Endpoints)
• Justice Dept. Accuses Walmart of Fueling Opioid Crisis (NYTimes)
• The final hours and days are ticking away on a $6B bet as deadline looms on a suspenseful FDA decision (Endpoints)
• Covid Antibody Drugs Go Unused as Need Soars (NYTimes)
• Trial of High-Dose Blood Thinners in ICU Coronavirus Patients Is Halted (NYTimes)
• Sorrento Therapeutics developing antibodies injection and nose drops to fight Covid-19 (CNBC)
• FY 2021 Appropriations Provides FDA Healthy Boost – Plus More COVID-19 Funds (Pink Sheet)

• Canada becomes second country to approve Moderna's COVID-19 shot (Reuters) (Health Canada)
• EMA organises a second public meeting about the new COVID-19 vaccines (EMA)
• Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC (MHRA)
• AstraZeneca submitted data for vaccine approval, UK's Hancock says (Reuters)
• Britain, Swiss firm Roche say COVID-19 tests can detect mutant virus (Reuters)
• Britain approves use of COVID-19 self-test kit (Reuters) (MHRA)
• Mexico to start COVID vaccinations as virus stretches hospitals (Reuters)
• China's CAS COVID-19 vaccine induces immune response in mid-stage tests (Reuters)
• Opacity dogs Chinese and Russian Covid vaccines (Financial Times)
• Global investors inject momentum into Hong Kong’s biotech craze (Financial Times)

• Warp Speed bets $356M to mass manufacture a Merck drug for severe Covid-19 (Endpoints)
• Dubai to begin inoculations with Pfizer-BioNTech vaccine from Wednesday (Reuters)
• Mutated coronavirus variant from S.Africa found in UK, health minister says (Reuters)
• Ninety-year-old woman first in Switzerland to get COVID-19 shot (Reuters)
• South Korea's Moon under fire for vaccine plans as COVID-19 cases surge (Reuters)
• Tropical Malaysia works to boost cold-storage, get more COVID-19 shots (Reuters)
• Philips clinical-grade wearable study in early COVID-19 detection gets DoD funds (MedtechDive)

• The US FDA’s Nifty Fifty (Pink Sheet)
• TikTok parent ByteDance hiring for AI drug discovery team (TechCrunch)
• Liver tumor in gene therapy recipient raises concerns about virus widely used in treatment (Science)
• New EU Clinical Trial System Has Implications For Wider Study Operations (Pink Sheet)
• Zogenix gets EU marketing authorisation for anti-seizure drug (Pharmafile)
• After multiple setbacks, Bristol Myers scuttles Opdivo program for brain tumor patients after failing to prolong lives (Endpoints)
• Merck buys into A2's T cell therapy platform; Small Soligenix reports PhIII fail in head and neck cancer (Endpoints)
• Amgen hands off rights to leprosy, tuberculosis med picked up as part of $13.4B Otezla deal (Endpoints) (Press)
• Cytokinetics may walk a lonely road to market with tarnished heart med omecamtiv after last partner bows out (Endpoints)
• Twist Biosciences plots its 'factory of the future' in Oregon, seeks to expand synthetic DNA client base (Endpoints)
• Takeda, PeptiDream to Develop Peptide Drug Conjugates for Neuromuscular Diseases (PharmaJapan)
• Nektar sells off royalties on its 2 approved drugs for $150M in cash, redoubling focus on I-O candidates (Endpoints)
• Riding on rosy estimates of Zolgensma sales, RegenxBio sells part of its royalty for $200M (Endpoints)
• Alnylam bids adieu to 2020 — and hello to a slate of new execs; Novavax taps Rick Crowley as COO (Endpoints)
• Roche's Phesgo Could Reduce Healthcare Costs In EU (Scrip) (Press)
• Bristol Myers Squibb Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme (Press)
• IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenström's Macroglobulinemia (WM) (Press)

• FDA 2020 recall roundup: A rough year for infusion pumps (MedtechDive)
• Fierce Medtech's Top 10 stories of 2020: COVID testing's ups and downs (Fierce)
• EU Industry Is Largely Ready For Brexit: This Is Why (MedtechInsight)
• Malaysia's Top Glove says will no longer fire whistleblowers; opens helplines for workers (Reuters)
• Top 10 Start-Up Spotlight Stories In 2020: Theradaptive’s ‘Bone Paint,’ BioIntelliSense’s BioButton, Heart Tech, Portable Ultrasound, Digital Health (MedtechInsight)
• Exec Chat: Medtronic CMO On How COVID-19 Has Changed The Company – And Where It’s Headed (MedtechInsight)

• Eli Lilly Beats Generic Cancer Drug Again At Fed. Circ. (Law360)
• Trump administration finalizes policy on 'value-based' drug deals (BioPharmaDive)
• Deborah Birx eyeing retirement after Biden transition (Politico)
• Trump pardons Chris Collins, former congressman imprisoned for biotech insider trading scandal (Endpoints)
• Del. Judge Nixes Equity Panel For 'Insolvent' Mallinckrodt PLC (Law360)
• PhRMA Urges Full Fed. Circ. To Walk Back New Venue Limits (Law360)
• Shkreli Can't Delay January FTC Deposition, NY Judge Says (Law360)
• Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada (Health Canada)
• Guidance on medical/surgical face masks and respirator standards - key performance aspects (TGA)
• Going Viral − The Ten Worst Prescription Drug/Medical Device Decisions of 2020 (Drug & Device Law)