Recon: China NMPA Approves Gilead’s Biktarvy for HIV-1; FDA Rejects Kala Eye Drug

• Sarepta says adverse event report for DMD gene therapy erroneously submitted (Reuters) (STAT) (Endpoints)
• Senators blast Novartis over data manipulation before approval of Zolgensma (STAT) (The Hill)
• ICER closely monitoring FDA’s Zolgensma investigation (PMLive)
• Potential new PrEP drug exposes gaps in data for women (Politico)
• House GOP unaware of Trump's health plan (Politico)
• FDA decision on Amarin heart drug delayed as agency to hold expert review (BioPharmaDive) (Fierce) (STAT) (Endpoints) (Press)
• Few Adults Used Prescription Drugs for Weight Loss and Insurance Coverage Varied (GAO)
• FDA rejects Kala's dry eye drug (Endpoints) (Press)
• Nektar battered over manufacturing issues and Bristol-Myers pullback (BioPharmaDive) (BioCentury)
• Gates Foundation snaps up top Apple Health researcher to run a new digital health group (CNBC)
• Q&A: The FDA’s digital health chief on how to regulate futuristic AI products (STAT)

• AstraZeneca's Tagrisso helps lung cancer patients live longer (Reuters) (PMLive) (Endpoints) (Press)
• China NMPA Approves Gilead’s Biktarvy for HIV-1 (Press)
• EU Takes Dispute With Turkey On Localization Policy To Next Level (Pink Sheet-$)
• Autolus delays multiple CAR-T clinical programs (Fierce) (Vantage)
• UK plans post-Brexit easing of rules on migrant scientists (Fierce)
• EC Cites Regulatory Controls for Medical Devices as US-EU Trade Barriers (Focus)
• Deploying Experimental Vaccines Against Ebola (Forbes)

• The acute myeloid leukaemia market (Nature)
• Perrigo delays prescription split after OTC business falls flat (Fierce)
• GAO Pushes FDA to Improve First Cycle Generic Approval Rate (Focus)
• Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers (Pink Sheet-$)
• Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat (Scrip-$)
• Top Scripps scientist and biotech co-founder makes an abrupt — and unexplained — exit (Endpoints)
• Dust Yourself Off and Try Again: GAO Report On ANDA Approval Shows that Multiple Review Cycles Are Still Often Necessary (FDA Law Blog)
• Amy Burroughs to lead Cleave Therapeutics; Cynthia Collins clinches Editas CEO job amid historic CRISPR move (Endpoints)
• Melinta chief John Johnson jumps ship — with the chairman — from another troubled antibiotics play (Endpoints)
• The FDA Aims To Strike Balance On Inspecting Physicians Who Compound Drugs (Pink Sheet-$)
• Ridge Properties LLC DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products Due to Microbiological Contamination and Superpotency (FDA)
• Lessons Learned From the Opioid Epidemic (JAMA)

• Sesen Bio Reports Positive, Preliminary Data Update from Phase 3 VISTA Trial for High-Risk Non-Muscle Invasive Bladder Cancer (Press)

• Guardant Health Preps Pan-Cancer FDA Bid, Highlights New MSI Validation Data (GenomeWeb)
• FDA Greenlights Clinical Studies of Paclitaxel Devices to Address Late Mortality Signal (Focus)
• Cardinal Health beats The Street on Q2, FY 2019 earnings, expects $145 million restructuring charge (MassDevice)
• Endologix shares dip on Q2 loss of $27.1 million (MassDevice)
• TransEnterix shares dive on disappointing Q2 sales (MassDevice)
• Nevro beats the Street with Q2 results (MassDevice)
• Endologix Receives IDE Approval for the Nellix Chimney EndoVascular Aneurysm Sealing Protocol (Press)
• Apple devices, in tandem with digital apps, could detect early signs of Alzheimer's, dementia: study (Endpoints)

• Presidential candidates aren’t talking about drug shortages. They should be (STAT)
• What We Know About Opioid MDL Settlement Talks (Law360-$)
• Retrophin paid Martin Shkreli 'undisclosed sum' to settle yearslong legal disputes (Endpoints)
• 'My Grandmother Could Have Filed This,' Valeant Judge Says (Law360-$)
• Med Device Co. Settles FCA Trade Violation Claims For $3.3M (Law360-$)
• Bayer has not proposed paying $8 billion to settle U.S. Roundup claims: mediator (Reuters)
• Trump Team Hits Brakes On Law That Would Curb Unneeded Medicare CT Scans, MRIs (NPR)
• Dense breast notification laws not leading to more screening ultrasounds (Reuters)
• The opioid crisis needs a long-term national strategy (The Hill)
• Hospitals Want Claim In Insys Ch. 11 That Could Hit $102B (Law360-$)
• Gov't Fights Insys Founder's Bid To Delay Sentencing (Law360-$)
• CMS Has Not Overseen States' Implementation of Changes to Third-Party Liability (GAO)
• Passive “Gatekeeping” in Biomet Hip Implant Daubert Decision (Drug & Device Law)
• Former FDA chief warns consumers that all forms of CBD in food is actually illegal (CNBC)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: MHRA Drops Statement That Avoiding No-Deal Brexit is the ‘Top Priority’ (Focus)
• Latest performance stats show NHS is 'struggling' (PharmaTimes)
• Export drugs and medicines: special rules (MHRA)

• FiercePharmaAsia—Daewoong, Evolus’ Botox rival; Surprise FDA visits?; Daiichi’s cancer nod (Fierce)

• Regulatory compliance issue remains top priority for Lupin: Nilesh Gupta (Pharmabiz)
• Technologies like blockchain have potential to ensure transparency in medicine supply chain: Experts (Pharmabiz)

• Notice: Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs (Health Canada)

• IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies (Focus)