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Regulatory Focus™ > News Articles > 2020 > 8 > Recon: Russia approves coronavirus vaccine before Phase 3 trials; Bayer to acquire women’s health fo

Recon: Russia approves coronavirus vaccine before Phase 3 trials; Bayer to acquire women’s health focused KaNDy therapeutics

Posted 11 August 2020 | By Michael Mezher 

Recon: Russia approves coronavirus vaccine before Phase 3 trials; Bayer to acquire women’s health focused KaNDy therapeutics

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump expected to give update on US COVID-19 vaccine development -White House (Reuters)
  • Novavax expects it can meet US COVID-19 vaccine demand in 2021, executives say (Reuters)
  • J&J eyes one billion doses of potential COVID-19 shot in 2021, weighs challenge trials (Reuters)
  • Merck Bets On a One-Shot Vaccine in Race With Its Faster Rivals (Bloomberg)
  • Moderna says uncertain about coronavirus vaccine patent exclusivity (Reuters)
  • Moderna Wants to Transform the Body Into a Vaccine-Making Machine (Bloomberg)
  • During Covid-19 Pandemic, Biotech IPOs Already Surpass Record (WSJ)
  • Trump: Executive order on pre-existing conditions is 'a signal' (Politico)
In Focus: International
  • Russia Approves Coronavirus Vaccine Before Completing Tests (NYTimes) (Reuters) (WSJ)
  • WHO says discussing new COVID-19 vaccine with Russia (Reuters)
  • Sinovac launches Phase 3 trial for COVID-19 vaccine in Indonesia, reports Phase 2 details (Reuters)
  • WHO: Coronavirus unaffected by seasonal changes (The Hill)
  • India's shortage of remdesivir is easing, says producer Cipla (Reuters)
  • Bayer takes on Astellas in purchase of experimental menopause relief (Reuters) (Endpoints) (Fierce)
  • Samsung Biologics plots $2B 'super plant' as COVID-19 sends sales through the roof (Fierce)
  • A hedge fund bets on a biotech startup to bring new drugs to China (BioPharmaDive) (Endpoints)
  • Canada Asks Insulin Makers To Rectify Inconsistent Product Monographs (Pink Sheet)
Coronavirus Pandemic
  • When will a coronavirus vaccine be ready? (Reuters)
  • Endpoints News ranks all 28 players in the Covid-19 vaccine race. Here's how it stacks up today (Endpoints)
  • Inspired by llamas’ unique antibodies, scientists create a potent anti-coronavirus molecule (STAT)
  • Over 900 US Health Workers Have Died of COVID-19. And the Toll Is Rising. (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 aide plasma donations (Fierce)
  • Arcturus Therapeutics begins human trials of potential COVID-19 vaccine (Reuters)
  • Mexico to conduct late-stage trials for China, U.S. COVID-19 vaccines (Reuters)
Pharma & Biotech
  • FDA gives thumbs-down on hearing loss drug, citing manufacturing issues, and sends Fennec stock reeling (Endpoints)
  • Five Top Drugmakers Reveal List vs. Net Price Gaps (Plus: The Trouble With Insulin Prices) (Drug Channels)
  • Gene Therapy Manufacturing Hurdle: Sponsors Unwilling To Share ‘Secret Sauce’ (Pink Sheet)
  • Biotechs Face Daunting Launch Environment Going It Alone (Scrip)
  • Otsuka’s 1st Half Pharma Sales Rise 7.6% as 4 Global Brands Fare Well (PharmaJapan)
  • JMA’s New Pharma Affairs Exec Wants More Stringent Rules on Sakigake, Conditional Approval (PharmaJapan)
  • Scottish HTA OKs Neratinib For Early-Stage Breast Cancer (Pink Sheet)
  • Eisai is creating a new US corporate, R&D HQ in Roche’s old Nutley, NJ campus (Endpoints)
  • Spark Therapeutics nabs CMO from new owner Roche (Fierce)
  • Teva's Ajovy, chasing Amgen and Lilly drugs, gains steam after autoinjector rollout (Fierce)
  • Harmony Biosciences sets terms on $100M IPO; FDA accepts a Protalix BLA for review (Endpoints)
  • Plotting to be the BridgeBio of AI, Atomwise lands $123 million Series B for hype-heavy platform (Endpoints)
  • Fulcrum stumbles in PhII of old GSK drug, sending shares tumbling (Endpoints)
  • Firdapse fails PhIII for myasthenia gravis as Catalyst keeps looking for expanded label (Endpoints)
  • Reata suggests Friedreich's ataxia program could be delayed, sending stock plunging (Endpoints)
  • Ligand scoops up Pfenex for up to $516M, adding proteins to their antibody chickens and delivery tech (Endpoints)
  • Despite Imminent Etanercept Launch, Lupin Cuts FY21 Forecast (Scrip)
  • AAMC, the medical school trade association, gave $500,000 to dark-money group in 2018 (STAT)
  • BD Announces Voluntary Recall of ChloraPrep™ 3 mL Applicator in Specific U.S. Territories and Countries (FDA)
  • With Livongo’s arsenal of health devices, Teladoc is poised to move into remote monitoring (STAT)
  • With Covid-19 halting clinical trials, wearables could be key — but data ‘wild west’ gets in the way (STAT)
  • Struggling Senseonics allies with blood glucose monitoring giant Ascensia, taps much-needed $80M (MedtechDive)
  • BD's FDA filing to update recalled Alaris pumps delayed by 6 months (MedtechDive)
Government & Regulatory
  • Atkinson v. Luitpold – Part III (Drug & Device Law)
  • Notice – Release of ICH S5(R3): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (Health Canada)
  • Eastern Kentucky Doctor and Assistant Plead Guilty to Unlawfully Distributing Opioids (DOJ)
  • Georgia Man and His Company Charged with Selling Misbranded Drug Advertised to Treat COVID-19 (FDA)
  • Opioid Cos. Say NY Trial Shouldn't Be Livestreamed (Law360)
  • SEC Reaches Settlement With Accused COVID-19 Fraudster (Law360)
  • Lawyer Says Thalidomide Client's Claims Are Years Late (Law360)
  • Allergan Says Breast Implant MDL Claims Are Preempted (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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