Recon: AstraZeneca halts COVID vaccine trial; France fines Roche, Novartis €444 over Lucentis marketing

• How drugmakers can keep their pledge and still deliver an October vaccine surprise (Reuters)
• FDA Sets Up Vaccine Safeguards to Counter Pressure From Trump (Bloomberg)
• FDA authorizes emergency use of COVID-19 test from Alphabet's Verily (Reuters)
• Liquid biopsy startup Grail, in filing for IPO, lays out investments and plans for growth (STAT)
• Drug, device makers paid teaching hospitals $832m in 2018, creating potential for COI (STAT)
• How biotech and pharma companies pay their CEOs, and their workers (BioPharmaDive)

• AstraZeneca halts Covid-19 vaccine trials to assess safety issue (Politico) (STAT) (Endpoints) (Reuters) (FT) (NYTimes)
• Britain's medical regulator says urgently reviewing AstraZeneca COVID-19 vaccine trial data (Reuters)
• EU enters final talks for BioNTech-Pfizer vaccine (Reuters) (Press)
• Regeneron expects to report biomarker data for COVID-19 therapy by September end (Reuters)
• Paying down more debt, Takeda offloads prescription drug portfolio for $562 million (Endpoints)
• Mylan boosts Euro portfolio with $756M rights deal for Aspen's injectable thrombosis meds (Fierce)
• France fines Roche, Novartis 444 million euros in ongoing eye drug clash (Reuters)
• EDQM Plans ‘Certificates Of Suitability’ Makeover (Pink Sheet)
• NICE turns down Celgene's Revlimid as multiple myeloma maintenance treatment (PharmaTimes)

• A New Theory Asks: Could a Mask Be a Crude ‘Vaccine’? (NYTimes) (NEJM)
• NIH director says will not compromise on coronavirus vaccine safety (Reuters)
• Top Senate Democrat says good chance coronavirus aid bill will pass (Reuters)
• McConnell Proposes Pandemic Relief Bill, Democrats Quickly Dismiss It As 'Emaciated (NPR)
• Catalent injects $130M into Maryland cell and gene therapy site drafted into COVID-19 vaccine hunt (Fierce)
• Brazil lab DASA to do tests for COVID-19 vaccine being developed by COVAXX (Reuters)
• Russia's RDIF to sell 32 mln COVID-19 vaccine doses to Mexican firm (Reuters)
• CanSino Phase 3 COVID-19 vaccine trial in Pakistan expected to begin this month (Reuters)
• Dr Reddy's launches Remdesivir under brand name 'Redyx' for Covid-19 treatment in India (Economic Times)
• LabCorp to launch single home swab test spanning COVID-19, flu, RSV (Fierce)
• Can plasma and antibody therapies help as world awaits Covid-19 vaccine? (FT)

• Pharma's battered rep gets a modest facelift in the latest industry ratings from Gallup — but it's still looking pretty bad (Endpoints)
• Phase 0/microdosing approaches: time for mainstream application in drug development? (Nature)
• FDA puts Roche's Tecentriq under the lens in breast cancer after recent trial flop (Fierce) (FDA)
• USP Proposes Analytical Methods For Drug Makers To Detect Nitrosamine Impurities (Pink Sheet)
• The Quality Lowdown: Warning Letters Suggest How The FDA Set Priorities During COVID-19 (Pink Sheet)
• The OxyContin Story: A Timeline Of Accomplishment And Controversy (Pink Sheet)
• OxyContin Reformulation Reduced Abuse Via Non-Oral Routes But Not Overall Abuse, US FDA Finds (Pink Sheet)
• With positive PhIII data, Merck sets up a blockbuster attempt to overthrow Pfizer's reigning Prevnar 13 (Endpoints)
• Jazz inks Redx pact to secure 2 targeted cancer therapies (Fierce)
• Maker of world's most expensive prescription drug flashes PhIII data for a potential fourth product (Endpoints)
• OncoImmune pulls in $56M Series B, hoping GvHD program can prove useful for Covid-19 (Endpoints)
• Dabbling in CD47, Pfizer infuses $25M into a biotech player touting positive monotherapy data (Endpoints)
• Longtime biotech vet Andrew Hirsch is taking the top job at C4 — and he clearly has some big plans (Endpoints)

• Ortho device reclassifications, MDUFA reauthorization among FDA's fall meeting lineup (MedtechDive)
• Edwards gets FDA approval for Sapien 3 in new patient population (MedtechDive)
• Surgeries keep rising, buoying Wall Street's year-end medtech outlook (MedtechDive)
• COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight (MedtechInsight)
• FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication (FDA)
• Summary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia (TGA)

• GAO: FDA Could Better Communicate with Airlines to Encourage Voluntary Construction Inspections of Aircraft Galleys and Lavatories (GAO)
• Opioid Manufacturer Indivior’s Former Global Medical Director Pleads Guilty in Connection with Drug Safety Claims (FDA)
• High Court Should Review Horizon Arthritis Drug Patent Case (Law360)
• Ohio Counties Blast Pharmacies' Review Bid In Opioid MDL (Law360)
• FTC Says 3rd Circ. Ruling Can't Help AbbVie In AndroGel Case (Law360)
• Fresenius Accuses Rival Of Infringing Naropin Patent (Law360)
• Indivior Wants Class Rep DQ'd In Suboxone Product-Hop Suit (Law360)
• Democratic AGs Return Fire In High Court Abortion Pill Row (Law360)
• Glaxo Loses Appeal For Asthma Inhaler Color Trademark In EU (Law360)