Regulatory Focus™ > News Articles > 2021 > 1 > Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after late

Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

Posted 13 January 2021 | By Michael Mezher 

Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA fights for independence in Trump administration's final days (Politico)
  • Johnson & Johnson Expects Vaccine Results Soon but Lags in Production (NYTimes)
  • Supreme Court Revives Abortion-Pill Restriction (NYTimes)
  • Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say (CNBC)
  • US to buy 1.25M additional doses of Regeneron's COVID-19 antibody cocktail (Reuters)
  • Biden’s Covid-19 team reconsiders pandemic plan in light of more infectious variants (STAT)
  • 27.7M doses of COVID-19 vaccines distributed, 9.3M administered: CDC (Reuters)
  • Flawed vaccine rollout will create political stars — and has-beens (Politico)
  • Sana Biotechnology, filing for IPO, aims for astronomical valuation (STAT)
In Focus: International
  • Pharma lobby warns against extending Covid jab times (FT) (Statement)
  • J&J likely to seek EU approval for COVID-19 vaccine in February (Reuters)
  • MEP Canfin to Commission: We need more details on CureVac vaccine contract (Politico)
  • AstraZeneca says to release 2 million vaccine doses a week to UK by mid-February (Reuters)
  • English health official says have been extracting extra doses of AstraZeneca vaccine (Reuters)
  • Baxter Germany to start production of BioNTech/Pfizer vaccine by early March (Reuters)
  • China's Sinovac defends COVID-19 vaccine after disappointing Brazil data (Reuters) (FT)
  • India wants Pfizer to do local study before approval (Reuters)
  • Mexico aims to fast track Russian Sputnik vaccine authorization after seeing data (Reuters)
  • Brazil to decide Sunday on emergency use of Chinese and British COVID-19 vaccines (Reuters)
  • Australian scientists suggest delaying AstraZeneca vaccine as infections fall (Reuters) (FT)
  • Australia's chief medical officer defends AstraZeneca's Covid vaccine amid efficacy concerns (The Guardian)
  • Turkey grants emergency authorization to Sinovac's CoronaVac: Anadolu (Reuters)
Coronavirus Pandemic
  • Second year of pandemic 'could even be tougher': WHO's Ryan (Reuters)
  • Facing New Outbreaks, China Places Over 22 Million on Lockdown (NYTimes)
  • Opinion: The World Is Desperate for More Covid Vaccines (NYTimes)
  • Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed (Pink Sheet)
  • US to Require Negative Virus Tests From International Air Passengers (NYTimes)
  • Doctor’s Death After Covid Vaccine Is Being Investigated (NYTimes)
  • CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts (FDA)
Pharma & Biotech
  • US FDA To Lose Another COVID-19 Response Leader With Anand Shah’s Resignation (Pink Sheet)
  • New Bayer drugs will not bridge revenue gap, says pharma head (FT)
  • What can a 157-year-old pharma giant bring to the table of cell and gene therapies? Quite a bit, Bayer says (Endpoints)
  • Bayer wins priority review for CKD program finerenone after PhIII data showed a delay in disease progression (Endpoints)
  • JPM21: Gene editing for heart disease, a new date to watch in Alzheimer's and Pfizer's deep pockets (BioPharmaDive)
  • US FDA Actions On Rx Drug Promos Covered New Territory Last Year (Pink Sheet)
  • FDA Defers Decision on Bevacizumab Biosimilar (Big Molecule Watch)
  • ViiV gets EU approval for children's HIV treatment (Pharmafile)
  • IO Biotech raises $155M to trial IDO and PD-L1 cancer vaccines (Fierce)
  • What if a pill could lower cholesterol like pricey injectables? Esperion intends to find out (STAT)
  • With KRAS breakthrough on the horizon, Amgen's David Reese reflects on sotorasib's looming review date and murky future (Endpoints)
  • Amgen ponies up $240M for Michigan discovery outfit's dendritic cell-based molecules for autoimmune disorders (Endpoints)
  • Pfizer's investment fund is making waves in VC — including a $25M bet on IBD player Vedanta Biosciences (Endpoints)
  • #JPM21: Albert Bourla prepares Pfizer to settle in to next phase post-Upjohn, but that doesn't mean he's ruling out deals (Endpoints)
  • A longtime Pfizer chief's ultra-quiet biotech re-emerges with new cash and plans for the clinic (Endpoints)
  • Flagship christens the latest startup to join the drug discovery fleet, this time focused on the lessons of cell death (Endpoints)
  • Takeda eyes pathway to natural killer therapies, teeing up $100M to partner with KSQ for its CRISPR-screened molecules (Endpoints)
  • News briefing: Merck picks up SHP2 option from Taiho-Astex deal; Taysha expands partnership with UT Southwestern (Endpoints)
  • IDO on the rebound? Danish outfit IO Biotech hopes so with oversubscribed Series B one month after BTD in melanoma (Endpoints)
  • Adaptimmune 'ready for primetime' as it prepares to launch T cell therapy for sarcoma, CEO Adrian Rawcliffe says (Endpoints)
  • Acorda offloads manufacturing operations to Catalent for $70M amid latest restructuring to keep the ship afloat (Endpoints)
Medtech
  • Essential IVD Document Delays Add To Concerns Over 2022 Deadline (MedtechInsight)
  • CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic (MedtechDive)
  • Allergan Aesthetics Enters Into Option to Acquire Cypris Medical (Press)
  • Illumina Launching Pan-Cancer IVD Test, Cloud-Based Bioinformatics Platform (GEN)
  • Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for Alzheimer's disease (Fierce)
  • JPM: Teladoc to pilot CGMs in Type 2 diabetes as Dexcom eyes new growth market (Fierce)
  • JPM: Steris snaps up infection prevention gear provider Cantel Medical for $4.6B (Fierce)
  • Big Changes Kicking In Under Australia’s Personalized Medical Devices Rules (MedtechInsight)
Government, Regulatory & Legal
  • Endocrinologists urge federal lawmakers to act to lower insulin costs (STAT)
  • Mexico publishes medicinal cannabis regulation, creating new market (Reuters)
  • Opinion: Federal Circuit Should Restore Generics ‘Skinny Label’ Process (Bloomberg)
  • PTAB Judge Skeptical Allergan's Juvederm Patents Are Valid (Law360)
  • Feds Want Jury Told Of Ex-Theranos CEO's 'Lavish Lifestyle' (Law360) (WSJ)
  • Pfizer Sues Over Generic For Arthritis Drug Xeljanz (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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