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June 15, 2020
by Michael Mezher

Recon: Germany to buy €300M stake in CureVac; AstraZeneca to supply EU with 400M doses of coronavirus vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA clears new version of Abbott's low-cost glucose monitor (Reuters)
  • FDA approves GSK unit's drug to treat infants and children with HIV (Reuters) (STAT) (FDA)
  • Eli Lilly starts trial of rheumatoid arthritis drug in COVID-19 patients (Reuters)
  • Moderna COVID-19 vaccine appears to clear safety hurdle in mouse study (Reuters)
  • White House pressure for a vaccine raises risk the US will approve one that doesn’t work (Politico)
  • What’s at stake for industry in the pharmaceutical Space Race for a Covid-19 vaccine (STAT)
  • A would-be chain of cancer centers wants to treat patients with Right to Try drugs, raising ethical questions (STAT)
In Focus: International
  • Germany to buy stake in CureVac as world races for COVID-19 vaccine (Reuters) (DW) (Financial Times)
  • AstraZeneca agrees to supply Europe with 400 million doses of COVID-19 vaccine (Reuters) (Bloomberg)
  • AstraZeneca picks Catalent for packaging, supplying potential COVID-19 vaccine (Reuters)
  • Shionogi boss cautions against hopes of early coronavirus vaccine (Financial Times)
  • Israel in talks to buy coronavirus vaccine from Moderna, YNET reports (Reuters)
  • Dr Reddy’s inks licensing pact with Gilead for Remdesivir to treat Covid-19 (Economic Times)
  • SK Biopharmaceuticals emerges from pandemic delays with pitch for $822M IPO (Endpoints)
  • Coronavirus hitting the Americas hardest says World Health Organization (Reuters)
  • Sinovac reveals positive preliminary data for COVID-19 vaccine (PMLive) (Endpoints) (STAT)
  • Slowing the Coronavirus Is Speeding the Spread of Other Diseases (NYTimes)
  • Up to 17 infected, 11 dead in new Ebola outbreak in Congo (Reuters)
Coronavirus Pandemic
  • The First Covid Vaccines May Not Prevent Covid Infection (Bloomberg)
  • Beijing district in 'wartime emergency' after virus cluster at major food market (Reuters)
  • Mutation Allows Coronavirus to Infect More Cells, Study Finds. Scientists Urge Caution. (NYTimes)
  • Masks significantly reduce infection risk, likely preventing thousands of COVID-19 cases -study (Reuters)
  • Missing data veils coronavirus damage to minority communities (Politico)
  • Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers (NYTimes)
  • Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients (Press)
  • COVID-19: UK and Europe life sciences regulatory developments (Pharmafile)
  • Coronavirus (COVID-19) Update: Daily Roundup June 12, 2020 (FDA)
Pharma & Biotech
  • bluebird set for 2021 filing for sickle cell gene therapy LentiGlobin (PMLive)
  • Will Clinical Trials Make a House Call? (LifeSciVC)
  • No Signature Required: FDA Provides Temporary Relief from Obligation to Obtain Physical Signatures for Prescription Drug Samples (FDA Law Blog)
  • EU regulators agree to review LEO's dermatitis drug (PharmaTimes)
  • India DoP comes out with draft guidelines for Rs. 6,940 crore PLI scheme to promote domestic production of bulk drugs (PharmaBiz)
  • PhRMA’s top communicator, a fierce defender of the industry, leaves for ExxonMobil (STAT)
  • UCB flashes the data behind its positive psoriasis readouts. Can it compete in a crowded field? (Endpoints)
  • Sure, Bit Bio got some significant cash for its cell coding work. But it’s the insiders who are backing them that will garner the attention (Endpoints)
  • Momenta clears a PhII hurdle on nipo — but one big rival remains well in the lead in this packed field (Endpoints) (STAT)
  • A pioneering immuno-oncology researcher heads back to Dana-Farber as Eli Lilly’s cancer R&D group undergoes a wrenching changeup (Endpoints)
  • Shattuck Labs ends silence with a shout-out on $118M raise for fusion protein work (Endpoints)
  • On a hiring spree, Moderna recruits another Amgen vet for the executive committee; Repare, Forma set terms for IPO (Endpoints)
  • EHA: AbbVie, Roche cement Venclexta's place in AML with survival win (Fierce)
  • EHA: Johnson & Johnson's Darzalex branches out beyond myeloma with AL amyloidosis win (Fierce) (Endpoints)
  • ADA: Novo Nordisk's long-lasting insulin candidate matches Lantus in phase 2 (Fierce)
  • ADA: Sanofi bolsters Soliqua with real-world data showing starting insulin, GLP-1 together helps control blood sugar (Fierce)
  • FDA Approves JUVÉDERM® VOLUMA™ XC for Enhancement of the Chin Region (AbbVie)
  • Plan to approach USFDA for re-inspection of key plants in next few months: Lupin (Economic Times)
  • High-Priced Drugs For Rare Disease: Leading US Payers Discuss Cost Concerns, Value-Based Contracts And ICER (Pink Sheet)
Medtech
  • White House Left States On Their Own To Buy Ventilators. Inside Their Mad Scramble. (KHN)
  • Medtronic deploys remote-controlled ventilators to lessen coronavirus exposure  (Fierce)
  • ADA: Abbott's real-world data show FreeStyle Libre lowered A1c in Type 2 diabetes, with or without insulin (Fierce)
  • ADA: Medtronic's next-gen artificial pancreas algorithm boosts time in range for young adults with Type 1 diabetes (Fierce)
Government & Regulatory
  • EMA Annual Report 2019 (EMA)
  • Submissions received: Scope of regulated software based medical devices (TGA)
  • Cherokee Nation Fights Bid To Nix Opioid Bellwether (Law360)
  • CVS-Only HIV Drugs Deny Meaningful Access, 9th Circ. Told (Law360)
  • Novartis Can't Duck Suit Over Cancer Drug Side Effects (Law360)
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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