Recon: CDC tells states to prep for COVID vaccine by November; 76 wealthy countries join COVAX plan

• Trump Admin Asks States to Be Ready for Vaccine by November (WSJ) (Reuters) (NYTimes) (FT)
• Pfizer targets end of next month for COVID-19 vaccine update (Reuters)
• Unlikely that a COVID-19 vaccine will be ready in October, but not impossible, Fauci says (Reuters)
• Merck CEO sees human trials for COVID-19 vaccine candidate 'fairly soon' (Reuters)
• Prominent biotech leaders release Covid-19 guidelines calling for FDA independence, data transparency (STAT) (Endpoints)
• Amarin loses appeal over heart drug patent, dashing its commercial hopes (STAT)
• Expert panel lays out guidelines for germline editing, while warning against pursuit of ‘CRISPR babies’ (STAT) (Science)
• Experimental drug for ALS, dreamed up in a dorm room, offers patients glimmer of hope (STAT) (Endpoints) (NPR)
• Akebia Therapeutics' anemia treatment fails to meet safety goal in late-stage study (Reuters)
• Trump Administration Will Redirect $62 Million Owed to the WHO (NYTimes)

• Vaccine group says 76 rich countries now committed to 'COVAX' access plan (Reuters)
• Pandemic review panel to ask 'hard questions', WHO files open, co-chairs say (Reuters) (STAT) (WHO)
• Sanofi and GSK move Covid-19 vaccine into human trials (STAT) (Reuters)
• China offers coronavirus vaccine candidates to aviation industry workers: notice (Reuters)
• Roche presents new data on efficacy of MS treatment Ocrevus (Reuters)
• Samsung’s Drugmaking Future Includes a $2 Billion ‘Super Plant’ Bigger Than the Louvre (WSJ)
• Building up its AI operations, GSK opens a $13M London hub with plans to woo talent now trekking to Silicon Valley (Endpoints)

• Coronavirus vaccines: frozen out (FT)
• Trump pivots to narrow coronavirus testing strategy as election looms (Politico)
• Dozens of U.S. Hospitals Poised to Defy FDA’s Directive on COVID Plasma (KHN)
• Woodcock Encourages Institutions to Continue COVID-19 Plasma Controlled Trial (Pink Sheet)
• HHS terminates Hamilton, Vyaire ventilator contracts (MedtechDive)
• Backed by Federal Funds, New Virus Tests Are Hitting the Market (NYTimes)
• ‘That’s certainly not my approach’: Fauci rejects pursuing herd immunity (Politico)
• Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020 (FDA)

• How Trump could use a rare regulatory maneuver to lower drug prices before Election Day, and how it could backfire (STAT)
• Italian vaccine makers in race to produce flu doses before winter (The Guardian)
• J&J, free from rival bidders, made Momenta wait on $6.5B deal (Fierce)
• The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’ (Pink Sheet)
• Gene Therapies: US FDA Clarity Needed On ‘Sameness’ Determinations For Products From Same Vector Class (Pink Sheet)
• NICE knocks back Janssen's Spravato nasal spray for the second time in treatment-resistant depression (Pharmafile)
• As Covid research heats up, J&J retires a BARDA-funded flu antiviral they worked on for 7 years (Endpoints)
• Akebia shares MACEd as their PhIII anemia drug fails on safety, offering rival FibroGen a huge advantage (Endpoints)
• Biofourmis raises $100 million for remote patient monitoring tools (STAT)
• Game change: A frontrunner in the cell therapy 2.0 field offers a first look at their lead therapy. And it’s a doozy (Endpoints)
• New targeted therapy approaches win Rain Therapeutics $63M — designed to beat a quick path to approval (Endpoints)
• Researchers teamed up to develop a 'three in one' HIV treatment — and the NIH is throwing in $14.6M (Endpoints)
• Crossover round? Check. Top team? Check. Taysha sails to an IPO with $100M initial ask (Endpoints)
• Dr Reddy's launches generic attention deficit disorder drug in US market (Economic Times)

• Medtronic Initiates Restructuring Program To Save Up To $475M Annually (MedtechInsight)
• Abbott’s Freestyle Libre 2 Gains Medicare Coverage (MedtechInsight)

• Explanatory note on general fees payable to the European Medicines Agency (EMA)
• Watchdog gives high marks to CMS competitive bidding program (MedtechDive)
• Perrigo Fights AbbVie's Bid To Send Pa. Antitrust Suit To NJ (Law360)
• FDA Remarks On CBD Should Restart Suit, Consumers Say (Law360)