Recon: Insulin Makers Brace for Brexit; Fire at Facility Housing Smallpox Virus in Russia

• Would a Purdue Bankruptcy Protect the Sacklers? Good Question. (NYTimes)
  Purdue Pharma’s Bankruptcy Deal Has Holes the Size of 24 States (Bloomberg)
• Purdue Pharma's battle isn't over (Politico)
• Former FDA Commissioner Scott Gottlieb joins Aetion's Board of Directors (Press)
• Opioid plaintiffs fight bid to disqualify US judge before trial (Reuters) (Law360-$)
• Sanofi Faces 1st US Suit Over Likely Carcinogen In Zantac (Law360-$)
• Acceleron scraps rare muscular dystrophy drug (PMLive) (Press)
• Cures for Hearing Loss May Be Found in New Drugs (WSJ)
• Millions of Americans’ Medical Images and Data Are Available on the Internet. Anyone Can Take a Peek. (ProPublica)
• Couple stole trade secrets from US children’s hospital to market their Chinese biotech, prosecutors say (STAT) (DoJ)
• Kite Pharma Hit With Patent Suit Over Cancer Drug (Law360-$)
• Abbott, Medtronic ink diabetes pacts with Sanofi, Novo Nordisk (MassDevice) (PharmaTimes) (Press)
• US records no new measles cases for first week since January (Reuters)

• With a backup to the backup, insulin makers say they're primed for Brexit (Reuters)
• As Congo’s Ebola Outbreak Drags On, Untracked Cases Sow Confusion (NYTimes)
• Blast sparks fire at Russian laboratory housing smallpox virus (The Guardian) (BBC)
• MHRA and the Bill & Melinda Gates Foundation to look at the safer, effective use of medicines during pregnancy (MHRA)
• Despite Calls for a Moratorium, More ‘Three-Parent’ Babies Expected Soon (Medium)
• Boehringer to launch first reusable soft mist inhaler (PharmaTimes)
• Three dead, hundreds ill in Spain listeria outbreak: WHO (Reuters)
• EU Court Advances Understanding Of SPC Patent Puzzle (Pink Sheet-$)
• BenevolentAI's latest financing could halve its $2B valuation — and that has Woodford watchers worried (Endpoints)

• Wholesale drug prices have been falling, and so have net prices (STAT)
• FDA Awards $4M in Grants to Support Development of COAs (Focus)
• FDA Explains Plans for New Pharmaceutical Quality Assessment System (Focus)
• FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development (Focus)
• Amplyx Inks Novartis Deal for Another Compromised-Immune System Drug (Xconomy)
• Most adults unaware of link between HPV and oral, penile and anal cancers (NBC)
• Curative Gene Therapy Coverage May Need Government-Funded Risk Pools (Pink Sheet-$)
• Scott Gottlieb has a new board position to add to the resume — and this one is focused on a favorite subject (Endpoints)
• OPDP DTC Research Studies Await Peer Review, Are Poised for Publication (CHC)
• Karyopharm lines up $150 million cash injection to back controversial drug launch (Endpoints)
• Biogen taps machine learning to help answer doctors' drug questions (Fierce)
• Recall of Takeda's Natpara leaves patients in health limbo (Fierce) (FDA)
• Expanded Access to Experimental Biologics (FDA)
• Longtime Crusader Against OxyContin Begins To See The Fruits Of Her Struggle (KHN)
• Older patients don't see diabetes recommendations same way doctors do (Reuters)
• Continuous Manufacturing and its Regulatory Challenge (Contract Pharma)
• Prostate drug may slow Parkinson's progression, big data suggest (Fierce)
• The first 'right-to-try' CRO launches (Fierce)
• Foghorn and Rgenix nab Agios, Roche veterans as new CMOs (Fierce)
• ECTRIMS: Atara's off-the-shelf T cells for EBV-driven MS show promise in small study (Fierce)

• Warts for the win: Aclaris' lead drug clears pivotal study (Endpoints)
• Alnylam Pharmaceuticals Announces Initiation of APOLLO-B Phase 3 Study of Patisiran for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy (Press)
• Arix Bioscience plc: Amplyx Unveils Expanded Pipeline and Reports Phase 2 Data from Lead Programme (Press)
• Santen’s Ikervis effective for dry eye (PharmaTimes)
• Half-Off Sale! Five Major Drugmakers Reveal Vast Gross-to-Net Price Gaps—and Why Rebate Reform Is Still Needed (Drug Channels)
• New data backs GeNeuro’s MS drug after Servier exit (PMLive)
• Poxel Initiates Phase 1b Multiple Ascending Dose (MAD) Trial for NASH Drug Candidate, PXL065 (Press)
• VALBIOTIS Presents Positive Results From a Study on TOTUM-63, Active Substance of VALEDIA®, Conducted by the CarMeN Laboratory in Lyon, at the Annual Meeting of the European Association for the Study of Diabetes (EASD) (Press)
• Omeros Corporation Announces Positive Results from Phase 1 Study of its Lead PDE7 Inhibitor in Development for Addiction (Press)
• Transgene Receives Approval from the French Health Authority (ANSM) to Initiate Two Clinical Trials of its Lead myvac™ Individualized Immunotherapy TG4050 (Press)

• DreaMed wins clearance, CE Mark for AI-powered insulin dosing software (MassDevice)
• FDA clears Rex Medical’s Revolution peripheral atherectomy device (MassDevice)
• CMR Surgical drums up another $243 million for Versius robotic surgery device (MassDevice)
• Gala Therapeutics Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx™ System for Chronic Bronchitis (Press)
• Philips wins $400m Pentagon deal for PACs imaging system (MassDevice)
• AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction (Press)

• Trump’s FDA Delayed Regulating Vaping Until the Crackdown (Bloomberg)
• US CDC activates emergency operations center for vaping-related illnesses (Reuters)
• California governor acts to stem 'epidemic' of youth vaping (Reuters)
• Mint, menthol e-cigarette liquids high in cancer-causing compound: study (Reuters)
• Eleventh Circuit Finds Difference of Opinion Not Enough for an FCA Claim (Drug & Device Law)
• Generic Cos. Pan ‘Irrelevant’ Doc Demands In Price-Fix Case (Law360-$)
• Investors Say Cancer Drug Co. Hyped Up Trial Results (Law360-$)
• PTAB Says Mass. Biotech's Milk Patent Ineligible For Review (Law360-$)
• Scientist Tells Calif. Court J&J Mesh Doesn't Degrade (Law360-$)
• Science & Tech Spotlight: Opioid Vaccines (GAO)
• Additional CMS Data and Oversight Needed to Help Ensure Children Receive Recommended Screenings (GAO)
• Lack of Personal Jurisdiction and Dearth of Plausible Claims Doom District of Arizona Infuse/Spinal Fusion Device Case (Drug & Device Law)

• FDA Advisory Committee Calendar

• NHS England response to Scottish decision to fund Orkambi (PharmaLetter-$)
• ABPI, Birmingham Health Partners team up for health challenges (PharmaTimes)
• #UKBIO19: Join GSK’s Hal Barron and a group of top biotech execs for our 2nd annual biotech summit in London (Endpoints)
• New details from European Commission on Expert Panels under MDR, IVDR (Emergo)
• Point-of-care testing cuts antibiotic use in COPD (Pharmaceutical Journal)
• Second Chance For Roche’s Polivy At CHMP (Pink Sheet-$)
• R&D offsets a small step in the right direction, Greek pharma says (PharmaLetter-$)

• Regulatory Digital Savvy: Taking China NMPA's New App For A Test Drive (Pink Sheet-$)
• Russia’s Biocad eyes massive Chinese expansion (PharmaLetter-$)

• CDSCO amends MD Rules to replace term “SLA” with “CLA” for effective implementation (PharmaBiz)
• Indoco Remedies expects double digit growth in FY 2019-20 (PharmaBiz)

• Essential principles checklist (medical devices) (TGA)