Recon: FDA communications shakeup continues; EU considers joining WHO vaccine purchasing scheme

• FDA to bring outside experts to review COVID-19 vaccines (Reuters)
• FDA shake-up continues as another comms official removed from top role (Politico)
• Convalescent plasma not recommended to treat COVID-19, government panel says (NBC) (FT)
• US says it won’t join WHO-linked effort to develop, distribute coronavirus vaccine (Washington Post)
• Trump says he will meet with drugmakers this week over pricing (Reuters)
• Pharma Lobby Disputes Trump’s Claim That Drug Companies Are Negotiating (Bloomberg)
• California may be the first state to develop its own generic drugs (LA Times)
• California OKs bill to flex power on prescription drugs (Modern Healthcare)
• FDA approves weekly therapy for adult growth hormone deficiency (FDA)
• Bristol Myers Squibb's decade-old Vidaza goes oral with FDA nod in acute myeloid leukemia (Fierce) (FDA)

• In Race to Secure Covid-19 Vaccines, World’s Poorest Countries Lag Behind (WSJ)
• In change of tack, EU leaves door open to COVID vaccines purchase through WHO (Reuters)
• AstraZeneca COVID-19 vaccine could be on the market by end of 2020 - Italy minister (Reuters)
• Japan considering offering coronavirus vaccine for free to all citizens: Kyodo (Reuters)
• Novo Nordisk launches new Rybelsus pill for type 2 diabetes in the UK (Pharmafile)
• EU OKs paediatric use of Gilead's Epclusa (PharmaTimes)
• NICE green light for immunotherapy Bavencio (PharmaTimes)

• Experts see a chance for a Covid-19 vaccine approval this fall — if it’s done right (STAT)
• Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming (KHN)
• Health Officials Worry Nation’s Not Ready for COVID-19 Vaccine (KHN)
• HHS deploys Abbott’s new coronavirus tests to states hit by wildfires, hurricanes (CNBC)
• U.S. CDC issues sweeping halt on residential evictions to combat virus (Reuters)
• COVID-19 cases in Europe back to March level, EU health body says (Reuters)
• Roche to launch 40M rapid coronavirus antigen tests per month, starting in Europe (Fierce)
• Florida cuts ties with Quest after delayed reporting of 75K COVID-19 test results (MedtechDive)
• Leaked email reveals CVS district leader instructed pharmacy staff not to tell patients their medications were filled by someone who tested positive for COVID-19 (BI)
• Coronavirus (COVID-19) Update: Daily Roundup September 1, 2020 (FDA)

• What we learned about the business of telemedicine from Amwell and GoodRx’s IPO filings (STAT)
• News briefing: Amarin's panel could put Vascepa patents in jeopardy; Santhera nabs a Duchenne drug (Endpoints)
• Enthused by PhII autoimmune data, J&J kept Momenta waiting in the lead-up to $6.5B buyout (Endpoints)
• (Do Not) Let The Chips Fall Where They May (LifeSciVC)
• Spurned by the FDA, Intercept brings out the budget axe and chops 170 jobs (Endpoints) (Fierce)
• Another Big Pharma 'lifer' in the top ranks of R&D is starting a new chapter in biotech (Endpoints)
• Bristol Myers snares another approval from the old Celgene pipeline, nabbing an overlooked OK (Endpoints)
• Weeks after launch, Alex Zhavoronkov's AI-inspired longevity spinout sells to Hong Kong-listed group (Endpoints)
• A pair of Bay Area biotech upstarts with deep pockets and a shared interest in curative cancer drugs join R&D forces (Endpoints)
• Casdin goes all-in on the SPAC game with $385M offering (Endpoints)
• More Evidence for SGLT2 Inhibitors in Heart Failure (NEJM)

• One Stop Shop: EU Devices And Diagnostics Regulatory Outlook Through To May 2021 (MedtechInsight)
• BD Provides Update on Previously Disclosed Recall of BD Alaris System Hardware (FDA)
• Chinese Medical Equipment Spared From Duties Until 2021 (Law360)

• Kite Pharma Wants Fed. Circ. To Nix Juno's $1.2B Patent Win (Law360)
• CMS Wants Medicare To Cover 'Breakthrough' Devices Faster (Law360)
• Dr. Reddy's Inks Deal To Exit Namenda Pay-For-Delay Suit (Law360)
• Cigna Gets Suits Over Drug Prices Pared Down (Law360)
• Teva Hit With Suit In NY Over Broken Birth Control Implant (Law360)