Recon: Roche Reports Positive Phase III Results for Tecentriq Combo in Bladder Cancer; Colombia Fines Pfizer for Exceeding Price Caps

• FDA approves Daiichi Sankyo's treatment for rare joint tumor (Reuters) (Endpoints) (FDA) (Press)
• White House Weighs September Rollout of Health Plan (WSJ) (Reuters)
• Drug industry urges Canada to act early on U.S. import plan (Reuters)
• Eli Lilly confirms probe by New York’s Attorney General over insulin prices (CNBC)
• States Clash with Cities Over Potential Opioids Settlement Payouts (NYTimes)
• Medicare boosts payment for breakthrough cancer therapy (Washington Post)
• CMS prescribes payment fix to resuscitate US antibiotic industry (Endpoints)
• Drugmakers Master Rolling Out Their Own Generics To Stifle Competition (KHN)
• Regulators, Gilead at odds over HIV drug's use in women (BioPharmaDive)
• Nobio gets FDA approval for anti-bacterial dental fillings (Reuters)
• GlycoMimetics shares nearly cut in half as Pfizer-partnered phase 3 drug flops (Fierce) (Press)

• Roche says test showed Tecentriq helped vs bladder cancer (Reuters) (Endpoints) (Press)
• Colombian regulator fines Pfizer for inflating prices on several medicines (STAT) (Colombia Reports)
• Global Regulators Caution Against Misinformation On Biosimilars (Pink Sheet-$)
• Congo races to contain Ebola after gold miner contaminates several in Goma (Reuters)
• Boris pledges a £1.8bn cash injection for the NHS (PMLive)
• AZ’ Forxiga label updated in EU for type II diabetes (PharmaTimes) (Press)
• Additional data for Boehringer's Giotrif combo shows strong overall survival benefit in lung cancer sub-population (Pharmafile)
• Takeda, Sosei form gastrointestinal disease R&D pact (Fierce) (Endpoints)
• EU Ready For WTO Showdown Over Turkish Drug Rules (Law360-$)

• Dog Toxicity Concerns Extend FDA’s Review of Intra-Cellular Neuro Drug (Xconomy)
• Drugs And Blockchains (Forbes)
• A compounder loses a battle with the FDA over using bulk substances (STAT)
• Alzheimer prevention failure rattles field, anew (Nature)
• Sickle Cell Disease Still Tends to Be Overlooked (NYTimes)
• Cancer Treatment at the End of Life (NYTimes)
• Pfizer needs to prove it's a growth story (BioCentury)
• Is Technology Really Speeding Up Adoption Of New Drugs? (Forbes)
• The Psychiatric 'Wonder Drug' That Almost No One Is Using (Vice)
• Longer-lasting HIV drugs (Nature)
• Close to a decade after Eli Lilly killed it, Jeffrey Bluestone's 'breakthrough' drug is back and being steered to the FDA (Endpoints)
• Racing after the leaders, Eli Lilly's migraine drug clears another pivotal study (Endpoints) (Fierce)
• Tiny Sienna is calling in Cowen as shares continue to languish long after a severe trial setback (Endpoints)
• Alzheimer’s patients didn’t decline after getting a cocktail derived from young blood, but big questions remain (STAT)
• Abortion Pills Should Be Everywhere (NYTimes)
• Joining Chang and Belldegrun, Rafael Amado takes a leading R&D post in the next big cell therapy revolution (Endpoints)
• Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? (RxTrace)
• The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs (Pink Sheet-$)
• Allogene names ex-Adaptimmune exec Amado as CMO  (Fierce)

• SFA Therapeutics, Inc. Requests FDA Orphan Drug Designation (ODD) for SFA001 for Treatment of Hepatocellular Carcinoma (HCC) (Press)
• Squarex Announces Positive Results from Completed Phase 2 Study of SQX770 in the Prevention of Recurrent Herpes Labialis (Press)
• Precigen Announces First Patient Dosed in Phase 1 Study of PRGN-3005 UltraCAR-T™ in Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Press)
• Poxel Initiates Pharmacokinetic (PK)/ Pharmacodynamic (PD) Study as part of the Phase 2a Clinical Program for PXL770, a Direct AMPK Activator for the Treatment of NASH (Press)

• Elon Musk Wants to Hack Your Brain. How will the FDA manage that? (Slate)
• Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy (FDA)
• Blood test could replace biopsy for rare cancer treated by Keytruda (STAT)
• These 7 trends matter the most for medtech in 2019 (MassDevice)
• Vascular Graft Solutions wins CE Mark for fistula repair device (MassDevice)
• Masimo lands CE Mark for infant hemoglobin monitor (MassDevice)
• RenalSense’s urine flow monitoring system wins CE Mark (MassDevice)

• Top Kidney Charity Directed Aid to Patients at DaVita and Fresenius Clinics, Lawsuit Claims (NYTimes)
• Purdue Pharma seeks to minimize its role in opioid crisis as it urges dismissal of Massachusetts suit (STAT) (Law360-$)
• Johnson & Johnson says jury ruled in its favor in lawsuit alleging baby powder caused mesothelioma (CNBC)
• CVS targets millennials with Amazon-like membership (CNBC)
• Incyte Sues Incysus For Having Too Similar A Name (Law360-$)
• J&J Unit Wins Toss Of Suit Over Breast Implants (Law360-$)
• Mylan CEO Must Face New EpiPen Deposition, Judge Rules (Law360-$)
• Missouri Amends Venue Provisions To Prevent Forum Shopping (Drug & Device Law)
• FDA Issues Final Guidance on Postmarketing Safety Reporting for Combination Products (FDA Law Blog)
• Legislators Introduce Bill to Increase Whole-Genome Sequencing Access for Pediatric Illnesses (GenomeWeb)
• Salix Clears Teva's Ulcerative Colitis Drug For 2021 Launch (Law360-$)
• AstraZeneca Hit With Pay-For-Delay Suit Over Seroquel XR (Law360-$)
• Allergan To Pay $2.7M To End Certain Generic-Delay Claims (Law360-$)
• Zimmer Hit With $7.7M Hip Implant Verdict In Damages Retrial (Law360-$)
• FDA Focus: What Foley & Lardner's Practice Chair Is Watching (Law360-$)

• FDA Advisory Committee Calendar

• Field Safety Notice: 29 July to 2 August 2019 (MHRA)
• bluebird working to open European gene therapy sites, but high price could be a hindrance (MedCity)

• Sun Pharma shuts 2 Gujarat R&D centres to cut costs (Economic Times)
• Bringing CAR T to India (BioCentury)
• Top 50 Indian cos post 14.1% sales growth in 2018-19, profit dips by 4.9% (Pharmabiz)
• India needs to increase quality & stability of generics to be on par with global standards: Haryana DC (Pharmabiz)

• Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance Document (Health Canada)

• A Brain Scan May Predict Alzheimer’s. Should You Get One? (NYTimes)
• U.S. recorded eight new cases of measles last week (Reuters)