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

• 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)

• 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)

• 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)

• 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)

• 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)