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22nd December 2020
by Michael Mezher

Recon: Drugmakers to test vaccines against new coronavirus strain; FDA approves Ridgeback Ebola drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Confusion reigns as companies, industries try to navigate US COVID-19 vaccine rollout (Reuters) (KHN)
  • FDA grants approval to Ebola drug from Ridgeback (BioPharmaDive) (FDA)
  • Fauci, Azar receive coronavirus vaccines at NIH event (Politico)
  • Joe Biden receives coronavirus vaccination (Politico)
  • A surge of state aid for vaccinations may already be too late (Politico)
  • FY 21 Appropriations Provisions and COVID-19 Relief / Stimulus Provisions Related to FDA (Alliance for a Stronger FDA)
In Focus: International
  • Drugmakers rush to test whether vaccines stop coronavirus variant (Reuters) (FT)
  • BioNTech says EU countries that want COVID-19 shots to get them within 5 days (Reuters)
  • India likely to approve AstraZeneca vaccine by next week – sources (Reuters)
  • French medical regulator to decide on COVID-19 vaccine on Dec. 24 (Reuters)
  • European medicines regulator says cyberattack limited to one IT application (Reuters)
  • China's Sinovac COVID-19 vaccine proves effective in Brazil trials (Reuters)
  • Mexico says to receive first vaccines from Pfizer on Wednesday (Reuters)
  • AstraZeneca-Amgen drug fails main goal of late-stage asthma study (Reuters)
Coronavirus Pandemic
  • The looming questions scientists need to answer about the new variant of the coronavirus (STAT)
  • Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions (Science)
  • U.S. plans to study allergic reactions from Pfizer’s Covid vaccine (CNBC)
  • Swiss start rolling out COVID-19 vaccine, elderly first in queue (Reuters)
  • Low Demand For Antibody Drugs Against COVID-19 (NPR)
  • Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S. (Reuters)
  • Malaysia buys AstraZeneca COVID-19 vaccines, seeks more from China, Russia (Reuters)
  • CanSino vaccine to be submitted for review in Mexico, minister says (Reuters)
  • Serbia gets first batch of Pfizer/BioNTech vaccine (Reuters)
  • Brazil health regulator certifies Sinovac's CoronaVac production standards (Reuters)
  • Quidel gets EUA to rival Abbott's rapid, point-of-care antigen test (MedtechDive)
Pharma & Biotech
  • The most impressive biotech VCs of 2020 (STAT)
  • GSK signs collaboration deal with Ligand targeting neurological disorders (PMLive)
  • WuXi Bio lays out €150M to take over Bayer plant in Germany, boosting pandemic supply network (Fierce)
  • Looking ahead to 2021: Hope for life beyond COVID-19 but shaped by the pandemic (Fierce)
  • Vertex Inks RNA Splicing Pact With Skyhawk (Scrip) (Endpoints)
  • Amgen Submits Sotorasib Marketing Authorization Application To The European Medicines Agency (Press)
  • Atomwise partners with Israeli incubator; Bayer collaborates with Veracyte in thyroid cancer (Endpoints)
  • More than 20 years into proteomics quest, SomaLogic keeps adding investors as it nears a potential public offering (Endpoints)
  • Rhythm Pharma knocked off stride as mixed PhIII obesity data for its sole big drug look ‘meh’ to many (Endpoints)
  • Peter Thiel joins funding round for peptide drug player in latest swing at emerging biotech market (Endpoints)
  • Dana-Farber backed Neomorph hunts 'undruggable' proteins with new round of investor cash for hires, development (Endpoints)
  • Amid a busy year and new leadership, Lonza looks to build bioconjugates capacity with Swiss expansion set for 2022 (Endpoints)
  • A neighborly visit turns into a bidding war: How Dan Skovronsky secured Eli Lilly's latest $1B buy (Endpoints)
Medtech
  • FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation (MedtechInsight)
  • The Times They Are A-Changin’: Opportunities In Medtech Regulation For The UK After Brexit (MedtechInsight)
  • A Deep Dive With US FDA’s Suzanne Schwartz: COVID-19, Cybersecurity, Device Shortages, And More (MedtechInsight)
Government, Regulatory & Legal
  • Federal Circuit Affirms PTAB Finding that Rituxan® Biogen Patent is Invalid (Big Molecule Watch)
  • Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. (Fed. Cir. 2020) (Patent Docs)
  • HHS approves rule targeting community health centers' drug discounts (Modern Healthcare)
  • How powerful health providers tamed a ‘surprise' billing threat (Politico)
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.