Recon: FDA extends review of Novartis MS drug; South Korea approves remdesivir for emergency use

• FDA delays decision on Novartis’ potential blockbuster MS drug, wiping away priority review (Endpoints) (Reuters)
• Estimating a US price tag of $5K per course, remdesivir is set to make billions for Gilead, says key analyst (Endpoints)
• Novavax partners with contract drugmaker for COVID-19 vaccine manufacturing (Reuters)
• Moderna to begin pivotal phase 3 trial of COVID-19 vaccine in July (PMLive)
• Reasonable to expect some coronavirus vaccine by year-end, Pentagon researcher says (Reuters)
• House Democrats seek information on coronavirus vaccine contracts (The Hill)
• Quest Diagnostics sees faster-than-expected recovery in US testing volumes (Reuters)
• Hype Collides With Science As FDA Tries To Rein In ‘Wild West’ of COVID Blood Tests (KHN)
• Vague testing guidance hinders business reopenings (Politico)

• Innovent starts China’s first trial of a novel cancer immunotherapy (STAT)
• Japan Eyes Coronavirus Vaccination Launch in First Half of 2021 (PharmaJapan)
• South Korea approves emergency use of Gilead's anti-viral drug to treat COVID-19 (Reuters)
• Lonza sets new goal to make Moderna COVID-19 vaccine ingredients (Reuters)
• UK doctors to trial ibuprofen in COVID-19 patients with breathing difficulties (Reuters)
• How China blocked WHO and Chinese scientists early in coronavirus outbreak (NBC)
• China rejects report that it delayed COVID-19 information sharing with WHO (Reuters)
• WHO director for Americas urges U.S. help as coronavirus surges in region (Reuters)
• New WHO Model Forecasts A Different Coronavirus Spread Pattern In Africa (NPR)

• The CDC waited ‘its entire existence for this moment.’ What went wrong? (NYTimes 1, 2)
• Top medical journals raise concerns about data in two studies related to Covid-19 (STAT) (Reuters) (In The Pipeline) (NYTimes)
• Heart Drugs Show Promise With Covid-19 Complications (WSJ)
• WSJ Tech Health Interview With Dr. Anthony Fauci (WSJ)
• U.S. temporarily to allow certain impurities in hand sanitizer (Reuters)
• Sweden should have done more to combat coronavirus, health chief says (Reuters)
• Study shows coronavirus antibodies in 5.5% of Dutch blood donors (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020 (FDA)
• FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19 (EMA)

• US seeks to 'onshore' drug production in response to COVID-19. Is pharma even interested? (Fierce)
• Revance and Mylan Move Forward With Development Plan for BOTOX Biosimilar (Big Molecule Watch)
• Benzodiazepines Tied to Higher Risk of Ectopic Pregnancy (NYTimes)
• Is a powerhouse Merck team preparing to leap past Roche — and leave Gilead and Bristol Myers behind — in the race to TIGIT domination? (Endpoints)
• A low-profile biotech bests Regeneron in high-profile patent suit (Endpoints)
• Forbion leads $62.5M round for neuro startup as ex-Teva R&D chief takes control; CSL Behring inks gene therapy pact in immunology (Endpoints)
• Fetroja Gets FDA’s Priority Review for Nosocomial Pneumonia (PharmaJapan)
• At Mayo Clinic, sharing patient data with companies fuels AI innovation — and concerns about consent (STAT)
• As NLRP3 players head for first clinical face-off, Novo, Sanofi fuel trans-Atlantic contender with $55M (Endpoints)
• Bullish biotech market propels Pliant to $144M IPO — as Novartis provides a $10M boost (Endpoints)
• Cameron Durrant hustled his way from the OTC sidelines right into the Covid-19 drug race. Death or glory lies straight ahead (Endpoints)

• FDA approves remote to check out Axonics neuromod device before MRI (MassDevice)
• Michael Seres, an influential patient who hacked together a ‘smart’ ostomy bag, dies at 51 (CNBC)

• Federal Court Issues Temporary Restraining Order Against Man Offering Fraudulent Coronavirus Treatments (DOJ)
• Critical medicines supply modelling supports return to elective surgery (TGA)
• California court hears appeal of $289 million verdict against Bayer in first Roundup cancer trial (Reuters)
• PhRMA Says Fed. Circ. Botched Patent Term Extension Ruling (Law360)
• Amgen Drops Alexion Blood Drug IPRs, Gets 2025 License (Law360)
• Acadia Can't Slip Investor Suit Over Parkinson's Drug Deaths (Law360)
• Teva Can't Escape Infringement Claim In Inhaler Patent Suit (Law360)