Regulatory Focus™ > News Articles > 2021 > 1 > Recon: CureVac partners with Bayer on COVID vaccines; Sinovac vaccine found 78% effective in Brazil

Recon: CureVac partners with Bayer on COVID vaccines; Sinovac vaccine found 78% effective in Brazil trial

Posted 07 January 2021 | By Michael Mezher 

Recon: CureVac partners with Bayer on COVID vaccines; Sinovac vaccine found 78% effective in Brazil trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna CEO says vaccine likely to protect for 'couple of years' (Reuters)
  • Operation Warp Speed’s Moncef Slaoui will stay on as a consultant for Biden (STAT) (Politico)
  • Serial biotech entrepreneur John Hood raises $62 million for company aimed at deadly lung disease (STAT)
  • Generic drug makers fear a ‘skinny labeling’ court ruling will pose a huge threat (STAT)
  • 17.3 million doses of COVID-19 vaccines distributed, 5.3 million administered: US CDC (Reuters)
  • Blood Plasma Reduces Risk of Severe Covid-19 if Given Early (NYTimes) (NEJM)
  • Fauci Says US Needs More Time To 'Catch Up' On Vaccine Rollout (NPR)
  • US healthcare M&A: strategies encapsulated (FT)
In Focus: International
  • CureVac strikes COVID-19 vaccine alliance deal with Bayer -Bild (Reuters) (FT)
  • Britain working with Pfizer, AstraZeneca to increase vaccine supplies (Reuters)
  • Roche, Sanofi arthritis drugs reduce death rates among sickest COVID-19 patients (Reuters)
  • Covid-19 Vaccines Expected to Work on South Africa Coronavirus Strain (WSJ)
  • Covaxin: Bharat Biotech completes volunteer enrollment for Phase 3 clinical trials (LiveMint)
  • Sinovac's COVID-19 vaccine 78% effective in late-stage trial in Brazil -source (Reuters) (NYTimes)
  • WHO Europe urges safe flexibility on timing of COVID-19 vaccine doses (Reuters)
  • Poorer countries could start getting COVID vaccines this month-WHO (Reuters)
  • As Olympics loom, Japanese approval of Moderna's COVID-19 vaccine unlikely till May (Reuters)
Coronavirus Pandemic                                                                                                                                                                  
  • Vaccine scepticism among medics sparks alarm in Europe and US (FT)
  • Delaying second Covid vaccine shots can be ‘very risky,’ says former FDA director (CNBC)
  • Beyond Politics — Promoting Covid-19 Vaccination in the United States (NEJM)
  • In Los Angeles and Beyond, Oxygen Is the Latest Covid Bottleneck (KHN)
  • Morocco approves AstraZeneca/Oxford COVID-19 vaccine- Minister (Reuters)
  • South Africa's Aspen could produce J&J COVID shots by end-March (Reuters)
  • S.Africa says to get 1.5 million vaccines from Serum Institute of India (Reuters)
  • Peru inks deals with Sinopharm, AstraZeneca for coronavirus vaccines -president (Reuters)
  • Over 4 million COVID-19 vaccine doses from China's CNBG administered in emergency use (Reuters)
  • UAE starts trials of Russia's Sputnik V coronavirus vaccine as cases rise (Reuters)
  • Kenya expects 24 million COVID-19 vaccine doses to start arriving next month (Reuters)
  • Brazil firm to request emergency use for Russia's Sputnik V vaccine in Feb -Valor (Reuters)
Pharma & Biotech
  • Pfizer beats Sarepta to the start of first late-stage Duchenne gene therapy trial (BioPharmaDive) (Endpoints)
  • DBV restructuring claims 200 jobs as it beats out a path toward peanut patch OK (Endpoints)
  • FDA extends immunodeficiency drug's shelf life as pandemic exacerbates shortages (Fierce)
  • Catalent inks deal to offload blow-fill-seal business to SK Capital (Fierce)
  • BioGeneration Ventures closes 4th fund, with $170M in tow for early European biotechs (Fierce)
  • President Signs the Orange Book Transparency Act (Big Molecule Watch) (Law360)
  • Kite and Oxford BioTherapeutics sign oncology research pact (PMLive)
  • NICE recommends AstraZeneca's FORXIGA for heart failure (Pharmafile)
  • Scorpion Therapeutics strikes major $162M funding round for 'precision oncology 2.0' (Fierce)
  • Indian Pharma exports get a boost as nations depend less on China (Economic Times)
  • Fujifilm's CDMO arm plots massive $2B plant in the US for broad range of therapeutics (Endpoints)
  • Dermira vets license back candidates from Eli Lilly to launch their own upstart (Endpoints)
  • EXCLUSIVE: Zai Lab’s Samantha Du scoops up China rights to an autoimmune drug with a hefty $175M licensing deal — heavily fronted with cash and stock (Endpoints)
  • Alnylam nears FDA filing for 4th RNAi therapy vutrisiran after late-stage data back use in protein misfolding disorder (Endpoints)
  • With decades in gene therapy under his belt, Ronald Crystal launches new venture with up to 18 candidates in the pipe (Endpoints)
  • Bristol Myers Squibb ices licensing pact with ArsenalBio to draft its designer T cells into the solid tumor fight (Endpoints)
  • Kira and its complement-target inhibitors plot run to the clinic with new investor cash just months after uncloaking (Endpoints)
  • Rick Klausner fronts cash for his fungus outfit LifeMine and brings on Nobel Laureate to further push cancer discovery (Endpoints)
  • Looking to solve the solid tumor puzzle box, Carisma aims to take 'CAR-M' groundbreaker into early-stage trial (Endpoints)
  • Abcuro will take an anti-KLRG1 antibody into the clinic with new funding, and has big plans for another (Endpoints)
  • Gary Glick, Keith Flaherty now have $270M to realize their vision for Precision Oncology 2.0 — we'll just have to wait for the details (Endpoints)
  • Werewolf prepares to bare its teeth in 1st trial for targeted cytokine tumor fighters with new round of investor cash (Endpoints)
  • Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years (Endpoints)
Medtech
  • Trump Signs Bill Allowing FDA Seizure Of Counterfeits (Law360)
  • MDIC Announces Pathology ‘Collaborative Community’ With FDA Involvement (MedtechInsight)
  • UK All-Party Report Assesses Brexit Medtech Impact While Germany Worries Over Border Delays (MedtechInsight)
  • French medtechs Carmat, CorWave advance heart failure device plans (MedtechDive)
  • New Mexico sues device sterilizer Sterigenics over ethylene oxide emissions (MedtechDive)
  • Medtronic’s ICM Proves Cost-Effective In Preventing Recurrent Stroke (MedtechInsight)
  • MTI’s Top 20 Of ’20: Medtech Industry Laser-Focused On FDA’s Quality System Reg Rewrite, Facility Inspections, And More (MedtechInsight)
Government, Regulatory & Legal
  • Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency (Pink Sheet)
  • Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2021) (Patent Docs)
  • Strike Three. Southern District of New York Joins Other Federal Courts In Blocking Trump Administration’s Most Favored Nation Drug Pricing Rule on Procedural Grounds (FDA Law Blog)
  • Allergan Says Federal Law Preempts Breast Implant Claims (Law360)
  • Hatch-Waxman Venue Issue Still Live After Fed. Circ. Ruling (Law360)
  • Gov't Pandemic Response Will Boost Life Sciences In 2021 (Law360)
  • Feds Want In On Allergan Collusion Suit Amid Criminal Probe (Law360)
  • 4th Circ. Undoes $1.25M Verdict In Pradaxa Suit (Law360)
  • W.Va. Opioid Distributor Bellwether Trial Set For May (Law360)
  • Fed. Circ. Won't Revive Axed Horizon Pain Drug Patents (Law360)
  • DOJ Misled Court About Planned Opioid Suit, Walmart Says (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.

Tags: US, worldwide

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