Recon: Russia approves coronavirus vaccine ahead of phase 3 trials; Bayer will acquire women’s health fo

Posted on August 11, 2020 | Through Michael mezher

Welcome to Regulatory Reconnaissance, your daily briefing on regulatory news and intelligence.

At a glance: United States

  • Trump expected to provide an update on the development of the US COVID-19 vaccine -White House (Reuters)
  • Novavax expects to be able to meet U.S. demand for a COVID-19 vaccine in 2021, executives say (Reuters)
  • J&J plans one billion doses of potential COVID-19 vaccine in 2021 and assesses provocation trials (Reuters)
  • Merck is betting on a one-shot vaccine in the race with its faster rivals (Bloomberg)
  • Moderna says he is uncertain about the patent exclusivity of the coronavirus vaccine (Reuters)
  • Moderna wants to turn the body into a vaccine-making machine (Bloomberg)
  • During the Covid-19 pandemic, IPOs in the biotechnology sector are already breaking the record (WSJ)
  • Trump: decree on pre-existing conditions is ‘a signal’ (Politico)

In short: International

  • Russia approves coronavirus vaccine before completing testing (NY Times) (Reuters) (WSJ)
  • WHO says discussing new COVID-19 vaccine with Russia (Reuters)
  • Sinovac Launches Phase 3 Trial For COVID-19 Vaccine In Indonesia, Phase 2 Details Report (Reuters)
  • WHO: Coronavirus is not affected by seasonal changes (The hill)
  • India’s remdesivir shortage is easing, says producer Cipla (Reuters)
  • Bayer takes Astellas to buy experimental menopause relief (Reuters) (End points) (Fierce)
  • Samsung Biologics Charts $ 2 Billion ‘Super Factory’ As COVID-19 Sends Sales Through the Roof (Fierce)
  • A hedge fund bets on a biotechnology start-up to bring new drugs to China (BioPharmaDive) (End points)
  • Canada calls on insulin manufacturers to correct inconsistent product monographs (Pink leaf)

Coronavirus pandemic

  • When will a coronavirus vaccine be ready? (Reuters)
  • Endpoints News ranks the 28 players in the Covid-19 vaccine race. Here’s how it stacks up today (End points)
  • Inspired by the unique antibodies of llamas, scientists create a powerful anti-coronavirus molecule (STAT)
  • More than 900 U.S. health workers have died from COVID-19. And the toll is increasing. (KHN)
  • Meet the most important federal official you probably don’t know – the man who holds the fate of the coronavirus vaccine in his hands (Washington post)
  • LabCorp COVID Tests Free for Three Months to Help Donate Plasma (Fierce)
  • Arcturus Therapeutics begins human trials of potential COVID-19 vaccine (Reuters)
  • Mexico to conduct advanced-stage trials for COVID-19 vaccines in China and the United States (Reuters)

Pharma and biotechnology

  • FDA gives opinion on hearing loss drug, citing manufacturing issues and sends stock of Fennec (End points)
  • Top five drugmakers reveal list versus net price differentials (plus: insulin pricing problem) (Drug channels)
  • Obstacle to the manufacture of gene therapy: the sponsors refuse to share the “ secret sauce ” (Pink leaf)
  • Biotechs face an intimidating launch environment that fools around on their own (Scrip)
  • Otsuka’s first half pharmaceutical sales grew 7.6% as 4 global brands fared well (PharmaJapan)
  • JMA’s new head of pharmaceutical affairs wants tougher rules on Sakigake, conditional approval (PharmaJapan)
  • Scottish HTA approves neratinib for early stage breast cancer (Pink leaf)
  • Eisai is in the process of establishing a new corporate research and development headquarters in the United States at the former Roche campus in Nutley, New Jersey (End points)
  • Spark Therapeutics chooses CMO of new owner Roche (Fierce)
  • Ajovy de Teva, in pursuit of Amgen and Lilly’s drugs, is gaining momentum after auto-injector rollout (Fierce)
  • Harmony Biosciences Sets Terms for $ 100 Million IPO; FDA accepts Protalix BLA for review (End points)
  • By plotting to be AI’s BridgeBio, Atomwise wins $ 123 million Series B for high-profile platform (End points)
  • Fulcrum stumbles into PhII of the old drug GSK, knocking down stocks (End points)
  • Firdapse fails PhIII for myasthenia gravis as Catalyst continues to seek expanded label (End points)
  • Reata suggests Friedreich’s ataxia program could be delayed, causing stocks to drop (End points)
  • Ligand is grabbing Pfenex for up to $ 516 million, adding protein to their antibody chickens and delivery technology (End points)
  • Despite the impending launch of Etanercept, Lupine cuts FY21 forecast (Scrip)
  • AAMC, the professional association of medical school, donated $ 500,000 to a black money group in 2018 (STAT)
  • BD announces a voluntary recall of the ChloraPrep ™ 3 mL Applicator in certain US countries and territories (FDA)


  • With Livongo’s arsenal of healthcare devices, Teladoc is poised to move to remote monitoring (STAT)
  • With Covid-19 clinical trials halted, wearable devices could be key – but ‘Wild West’ data gets in the way (STAT)
  • Senseonics allies struggling with blood sugar monitoring giant Ascensia, mine much-needed $ 80 million (MedtechDive)
  • BD’s update filing with the FDA recalled the 6-month delayed Alaris pumps (MedtechDive)

Government and regulation

  • Atkinson v. Luitpold – Part III (Medicines and Devices Act)
  • Advisory – ICH S5 (R3) Release: Detection of Drug Reproductive Toxicity and Male Fertility Toxicity (Health Canada)
  • Eastern Kentucky doctor and aide plead guilty to illegally distributing opioids (DOJ)
  • Georgia Man and his company have been accused of selling a bad brand drug advertised to treat COVID-19 (FDA)
  • Opioid Cos. Let’s say the New York essay shouldn’t be televised live (Law360)
  • SEC Reaches Deal With Fraudster Accused Of COVID-19 (Law360)
  • Lawyer says a client’s claims of thalidomide are years overdue (Law360)
  • Allergan Says MDL Breast Implant Claims Are Preempted (Law360)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you top regulatory, biopharmacy and medical technology news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

© Society of Regulatory Affairs Professionals 2021.

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About Kristina McManus

Kristina McManus

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