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

ReconRecon | 23 December 2020 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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