Recon: AstraZeneca begins US Phase III COVID vaccine study; FDA approves Medtronic’s new automated insulin delivery system

• Early vaccine approval is biggest test yet for FDA chief (FT)
• As fears of a politically-motivated vaccine EUA grow, Eric Topol delivers an ultimatum to commissioner Hahn: Stand up or resign (Endpoints) (Medscape)
• AstraZeneca's COVID-19 vaccine candidate begins late-stage US study (Reuters)
• Congressional committee to subpoena AbbVie in drug pricing investigation (STAT) (Reuters)
• FDA OKs New 'Artificial Pancreas' Medtronic 770G (Medscape) (Bloomberg) (FDA)
• Mylan launches a low-cost biosimilar insulin, but experts say many patients may not save on costs (STAT) (Scrip) (Big Molecule Watch) (Press)
• HHS bids $250 million contract meant to 'defeat despair and inspire hope' on coronavirus (Politico)
• GM, Ventec Life Systems deliver 30,000 ventilators to US government (Reuters)

• EU offers 400 million euros to WHO-led COVID-19 vaccine initiative (Reuters)
• Japan to participate in WHO coronavirus vaccine programme (Reuters)
• AstraZeneca, Oxford Biomedica expand COVID-19 vaccine supply tie-up (Reuters)
• Canada signs deals with Novavax, J&J for COVID-19 vaccines (Reuters)
• Delivering super-cooled COVID-19 vaccine a daunting challenge for some countries (Reuters)
• Health Canada changes course on COVID testing at home (Reuters)
• Sanofi says Kevzara drug fails as possible COVID-19 treatment (Reuters)
• Pharma industry calls on UK to support medical research charities (Financial Times)
• Covid: Venezuela seeks testers for Russian vaccine (BBC)

• These Scientists Are Giving Themselves D.I.Y. Coronavirus Vaccines (NYTimes)
• Coronavirus cases are on the rise again across more than half of the US (CNBC)
• Europe sees sharp rise in the number of new coronavirus cases, as Spain and Russia infections spike (CNBC)
• New Trump pandemic adviser pushes controversial ‘herd immunity’ strategy, worrying public health officials (Washington Post)
• Private coronavirus task force reports warned states of virus spread (The Hill)
• Comparisons of COVID-19 saliva, swab tests paint mixed picture (MedtechDive)
• Coronavirus (COVID-19) Update: Daily Roundup August 31, 2020 (FDA)
• The US FDA And The Dog That Didn’t Bark (Pink Sheet)

• US FDA Approval Activity Could Cool Down In September (Pink Sheet)
• US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse (Pink Sheet)
• In the footsteps of AstraZeneca, Novartis commits to carbon-neutral supply chain by 2030 (Endpoints)
• After Bristol snub, Gilead pens $120M upfront, $685M in biobucks for early Jounce cancer program (Fierce) (Endpoints)
• Carlyle Group injects $260M into a leading cardio player in China, grabbing a seat at the deals table (Endpoints)
• Canadian biotech to discontinue omega-3 program after second PhIII fails on significant triglyceride reduction (Endpoints)
• Mylan yanks 4 lots of heart health, hemophilia injectables over packaging mix-up (Fierce)
• Boston Pharmaceuticals raids Novartis' store again, nabbing a new NASH asset (Fierce) (Endpoints)
• Lumen Bioscience reels in $16M Series B to 'democratize' biologics (Endpoints)
• Nimbus Therapeutics nabs AstraZeneca's Edmondson as new chemistry lead (Fierce)
• AZ' Imfinzi bags new EC approval for lung cancer (PharmaTimes)
• Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis (Press)
• Keeping In Line With The EU Rules When Promoting Products & Disseminating Information In A Socially-Distanced World (Pink Sheet)

• EU MDR costing smaller medtechs 5% of their annual sales: survey (MedtechDive)
• Baxter wins FDA De Novo for more expansive dialyzer (MedtechDive)
• HHS Lab Test Rule's Likely Impact During And After COVID-19 (Law360)
• Labs scramble after FDA loosens regulations on some tests (Modern Healthcare)
• Q2 Recalls Snapshot: Recall Events Rise 31% While Recalled Units Slide (MedtechInsight)
• Profile: FDA’s Bakul Patel On The Inevitable Future Of Digital Health (MedtechInsight)
• Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS (Press)
• Masimo scores extended FDA clearance for cerebral hemoglobin monitoring (MobiHealthNews)

• Coalition urges Justice Department to seek criminal charges against opioid executives (STAT)
• Small vape makers seek another extension on a looming FDA application deadline, sparking battle with advocates (STAT)
• AbbVie Points 3rd Circ. To School Board Ruling In FTC Case (Law360)
• Ex-Indivior Exec Inks Plea Deal In Suboxone Opioid Case (Law360)
• States Urge High Court To Revive FDA's Abortion Pill Rules (Law360)
• Markson Sparks fined $26,640 for alleged unlawful advertising of a medical device in relation to COVID-19 (TGA)