Recon: Roche Raises Forecasts on Strong Sales of New Drugs; CVS Fined for Filling Fake Percocet Prescriptions

• CVS Fined $535K for Filling Forged Percocet Prescriptions (NYTimes) (The Hill)
• Stanford clears three faculty members of ‘CRISPR babies’ involvement (STAT) (NYTimes)
• As calls mount to ban embryo editing with CRISPR, families hit by inherited diseases say, not so fast (STAT)
• ‘Patients are not a company’s resource’: FDA cancer czar Richard Pazdur has a bone to pick with the top R&D execs in cancer (Endpoints)
• J&J’s new ketamine-like depression drug Spravato off to ‘very, very strong start,’ company says (CNBC)
• Most people pay less than $5 per month for the drug. But some pay $11,002 (STAT)
• FDA progressive device approval proposal raises eyebrows (BioPharmaDive)
• PhRMA's DTC defense rolls out on airwaves and online (BioPharmaDive)
• Republicans reject Democrat-led attempts at tightening state vaccine laws (Politico)
• FDA to Launch New Website Next Week (Focus)
• FDA Halts All US Sales of Surgical Mesh (Focus) (Reuters) (FDA)
• FDA’s Sharpless Vows Continuity (BioCentury) (Endpoints)
• DHS considering classifying fentanyl as weapon of mass destruction: report (The Hill) (CNBC)

• Roche's New Cancer, MS Drugs Pay Off With a Forecast Boost (Bloomberg) (WSJ) (Financial Times) (Press)
• Many essential drugs priced much higher than manufacturing cost: WHO (Economic Times)
• IGBA Outlines Steps Needed for a Successful Biosimilar Regulatory System (IGBA)
• GSK warns of possible layoffs as Barron's revised R&D strategy takes effect (Fierce)
• China introduces new laws to ensure steady supply of drugs (Pharmafile)
• WHO Consults On Remaining Shelf-Life Policy For Medical Products (Pink Sheet-$)
• Recordati to seek Canadian approval for kidney disease drug (Reuters)
• London listed PureTech Health joins forces with ninth big pharma partner — Boehringer Ingelheim (Endpoints)
• GlaxoSmithKline R&D reorganization triggers layoffs at Stevenage (Endpoints)
• NICE recommends Akcea's Tegsedi for rare, life-threatening progressive disease (Pharmafile)
• Stem cell transplant firms Kiadis and CytoSen join forces (PMLive) (Endpoints) (Evaluate)
• Revenue plunges, stock takes a drubbing, but Teva CEO Kåre Schultz still grabs $32.5M in chart-topping compensation (Endpoints)
• Wuxi Biologics To Supply CMC And Commercial Manufacturing For I-Mab (BioCentury)
• LifeArc licenses discovery programme to Daiichi Sankyo (PharmaTimes)
• MS Pharma ink deal for acquisition of Genepharm (Pharmafile)
• Ebola is real, Congo president tells skeptical population (Reuters)
• Ebola survivors comfort sick and frightened in Congo outbreak (Reuters)

• Opioid Users Call Kratom a Godsend. The FDA Says It’s a Menace. (NYTimes)
• 5 names to know at Amazon: the key players behind its health care push (STAT)
• With FDA decision near, Novartis bolsters SMA gene therapy case (BioPharmaDive)
• Novartis’ wet AMD drug gets FDA filing (PharmaTimes)
• Part-revived pig brains raise slew of ethical quandaries (Nature)
• FDA scientists discover key chemical steps in formation of microparticles carrying abnormal hemoglobin in sickle cell disease (FDA)
• San Francisco’s Mission Bay neighborhood was supposed to be a thicket of biotech. What went wrong? (STAT)
• Fresh safety, tolerability data snapshot from early-stage study of Wave’s DMD drug spooks investors (Endpoints)
• In another CRISPR first, Penn researchers dose US cancer patients with gene-edited T cell therapy (Endpoints)
• Baby Steps To Real-World Evidence Of Efficacy: External Controls Gain Popularity In Rare Disease Trials (Pink Sheet-$)
• Turning Point Prices IPO, Raising $166M to Test Cancer Drugs (Xconomy)
• Foul play with generic drugs threatens American lives (The Hill)
• FDA warns maker of children's OTC drugs after bacteria found in water system (Fierce)
• FDA Testing Data Exchange Standards For Drug Specifications Under PQ/CMC Pilot (Pink Sheet-$)
• Biotech startup grabs $27M launch round to pursue an R&D path blazed at Harvard and Boston Children’s (Endpoints)
• The Quality Lowdown: Foreign Burden, Border Destruction, Particles, Sterility (Pink Sheet-$)
• Bristol-Myers Squibb Company Announces Commencement of Exchange Offers and Consent Solicitations for Celgene Notes (Press)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Individual Patient Expanded Access Applications (FDA)
• Sunscreen Drug Products for Over-the-Counter Human Use; Correction (FDA)
• Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment (FDA)

• FDA Grants Breakthrough Device Designation For Advanced Prenatal Therapeutics' Targeted Apheresis Column For Preeclampsia (Press)
• US Food and Drug Administration Approves DUAKLIR® PRESSAIR® (aclidinium/formoterol) for Patients with Chronic Obstructive Pulmonary Disease (COPD) (Press)
• Vaxart Doses First Patient in Randomized Cohort of Bivalent Norovirus Vaccine Phase 1b Clinical Trial (Press)
• GenSight Biologics Reports Positive Follow-up Results at Week 72 of the RESCUE Phase III Clinical Trial of GS010 in Leber Hereditary Optic Neuropathy (LHON) (Press)

• Most type 2 diabetes apps lack real-time advice on blood sugar management (Reuters)
• Experts Tell Device Companies Not to Fret Over QMS Transition (Focus)
• Glaukos’ iStent Has Strong Showing in 5-Year Data (MDDI)
• Medtronic VenaSeal(TM) Closure System Demonstrates Durable and Consistent Outcomes at Five Years in Patients with Chronic Venous Disease (Press)
• Medtronic Data Expands on Key Aortic Solutions for Challenging Anatomies (Press)
• Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC (Press)

• Doctors in five states charged with prescribing pain killers for cash, sex (Washington Post) (DoJ)
• FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements (FDA)
• UnitedHealth CEO says ‘Medicare for All’ would ‘destabilize the nation’s health system’ (CNBC)
• Ex-Theranos CEO Says Feds Are Stonewalling Over Docs (Law360-$)
• A first-of-its-kind law in Tennessee limits lawyers’ ads seeking to sue drug makers (STAT)
• How a Dark Web Drug Ring Was Uncovered After Suspicious A.T.M. Withdrawals (NYTimes)
• Delaware Federal Court Rejects Innovator Liability (Drug & Device Law)
• Vitamin Shoppe to sell edible CBD supplements as consumers clamor for cannabis compound (CNBC)

• FDA Advisory Committee Calendar
• Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public Workshop – 12 June 2019

• Health industries welcome unprecedented progress leading to an adoption of Horizon Europe, its areas for missions and partnerships (EFPIA)
• Department of Health and Social Care seeks new Chair to lead NICE Board (NICE)

• Asia Regulatory Roundup: Australia and New Zealand Defer Decision on Potential Breast Implant Ban (Focus)
• China's GenScript starts on plasmid, virus making facility (Fierce)
• WuXi Biologics Successfully Completed First FDA Routine GMP Inspection (Press)

• DoP defers implementation of barcode at primary packs for all medicines procured under public procurement to April 1, 2020 (PharmaBiz)

• 2019 seasonal influenza vaccines (TGA)

• Health Canada Opens Generic Drug Guidances for Consultation (Focus)
• Summary Safety Review - Intragastric Balloons - Health Canada (Health Canada)
• Summary Basis of Decision - Mifegymiso (Health Canada)