Recon: Breakthrough status for Farxiga; 'Transformative' Zolgensma data

• President Trump Tests Positive for Coronavirus (WSJ) (NYT) (Washington Post) (CNBC) (Politico) (BBC) (Reuters)
• First doses of US vaccine must be strictly rationed, says report (Financial Times)
• Dr. Scott Gottlieb sees antiviral remdesivir as best coronavirus treatment should Trump need one (CNBC)
• Where was Trump — and who was he with — before testing positive for the coronavirus? (Vox)
• What Happens If Trump's Health Worsens After Testing Positive For The Coronavirus (NPR)
• Disgraced researchers can still reap drug industry payouts (Science) (ScienceMag)
• Expert panel recommends U.S. join international vaccine pool, contribute vaccine to low-income nations (STAT) (Reuters)
• Dems slam drug pricing strategies as 18-month probe comes to an end (Endpoints)

• Middle East And North Africa Dip Toes In HTA And Access Agreements (Pink Sheet)
• Canada to start rolling review of a COVID-19 vaccine submission (Pharmaletter) (Reuters)
• EMA accepts application for bluebird bio’s Lenti-D in CALD (PMLive)
• Safety warnings for opioid medicines in UK to be added to labels (EPR)
• Could GDPR be impeding the global COVID-19 pandemic response? (EPR)
• Phase I trial of intranasal COVID-19 vaccine spray approved in China (EPR)
• Mylan-Upjohn merger receives go ahead from Europe, Australia and New Zealand (GaBI)

• HHS Shifts Remdesivir Distribution To Gilead As Supply Crunch Eases (Pink Sheet) (Pharmaletter)
• EMA committee probes possible kidney injury from Gilead's remdesivir (Reuters)
• New global lab network will compare COVID-19 vaccines head-to-head (Reuters)
• Pfizer chief hits out at politicisation of Covid-19 vaccine (Financial Times)
• Pfizer CEO says Covid vaccine trial won't be rushed by political pressure (NBC) (Endpoints)
• AstraZeneca’s COVID-19 vaccine trials resume in Japan but still on hold in US (Pharmafile)
• Should people of color get access to the Covid-19 vaccine before others? (Vox)
• Diversity emerges as key challenge for coronavirus drug trials (The Hill)
• Nitric oxide a possible treatment for COVID-19 (AAAS)
• New York launches coronavirus contact tracing app as cases rise in hot spots (CNBC)
• President Trump Has Consistently Undermined White House Coronavirus Task Force (Forbes)
• Coronavirus (COVID-19) Update: Daily Roundup October 1, 2020 (FDA)
• How Russia shortened the Covid vaccine race in rush to declare victory (Economic Times)
• COVID-19 vaccine rollout unlikely before fall 2021, experts say (Economic Times)

• The FDA hands Farxiga 'breakthrough' status in CKD, clearing path for AstraZeneca's much-touted therapy (Endpoints)
• IGBA Calls For ‘Streamlining’ Of Global Biosimilars Process (Pink Sheet)
• Amgen Shadow Pricing Of Enbrel Under Scrutiny At US House Hearing (Pink Sheet)
• Gilead's Truvada faces Teva generics assault amid Descovy switching campaign (Fierce Pharma)
• C4's Andrew Hirsch blows up IPO to $182M, while oncolytic virus upstart nabs $87M offering (Endpoints)
• Novartis cites 'transformative' data on Zolgensma as it rolls out SMA gene therapy in Europe (Fierce Pharma) (Pharmafile)
• Ovid Reports Results from Studies in Rare Epilepsies (Global Genes)
• Two top execs in Sanofi's R&D group are hitting the exit in a shakeup as Frank Nestle moves up to CSO (Endpoints)
• Genentech neoantigen deal gives Vaccibody runway to speed up infectious disease pipeline  (BIocentury)
• Old Drug Turned ‘Cash Cow’ as Company Pumped Price to $40K a Vial, Emails Show (KHN)
• Merck’s Roger Perlmutter joins board of AI drug discovery startup Insitro (STAT) (Endpoints)
• Cormorant's Bihua Chen joins the SPAC game, looking to raise $100M for a company that matches 5 key criteria (Endpoints)

• Boston Scientific Takes on Systemic Racism (MD+DI)
• Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets (MedTech Dive)
• AdvaMed sends CMS reform wishlist to boost digital health device coverage (MedTech Dive)
• Medtronic hit with DOJ ventilator antitrust probe (MedTech Dive)

• Assessing the Administration’s Proposal for Reducing Insulin and Epinephrine Costs (AAF)
• Drugmakers and PBMs Face Lawsuit Together for the First Time on Insulin Price Fixing (FDANews)
• Policies to Achieve Near-Universal Health Insurance Coverage (CBO)
• Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters (PubMed)
• Court’s newest ERISA dispute will clarify states’ authority to regulate prescription-drug middlemen (SCOTUSblog)
• Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research (FDA)
• China’s drug agency proposes changes to patent law (GaBI)