Recon: Regeneron’s Eylea Stumbles as FDA Issues CRL; Amicus Sets $315,000 Price for Fabry Disease Drug

• Drug pricing watchdog group targets California Dem in $500K ad buy (The Hill) (STAT)
• Amicus sets $315,000 price for new Fabry disease treatment (Reuters) (STAT) (Endpoints)
• St. Jude and Mustang Bio enter into exclusive worldwide license agreement (Memphis Business Journal-$) (Endpoints) (Fierce)
• MD Anderson, Accelerator bake up Magnolia, an NYC biotech in neuroprotection, with $31M series A (Fierce) (Endpoints) (Forbes)
• New drugs so pricey they need new payment plans (Politico’s Prescription Pulse)
• Fresh from hauling in GSK’s budget-priced gene therapy group, Orchard harvests $150M mega-round. Is it time to IPO? (Endpoints) (Reuters)
• Regeneron’s Eylea Stumbles as FDA Issues CRL for New Dosing Label (BioSpace) (Endpoints)
• Drug Lobby Quietly Spent Heavily Ahead of 2016 Election (Bloomberg)
• Combining common drugs with a high price tag (Axios)
• That pathetic Alzheimer’s pipeline? It’s even worse than you think (STAT-$)

• The Unlikely Source of a Healthtech Revolution (Bloomberg)
• Essure sterilisation device: Australian women to launch lawsuit (BBC News) (The Guardian)
• Samsung Bioepis to start clinical trials of first new drug candidate with Takeda Pharmaceutical (The Korea Herald) (Korea Biomedical Review)
• Vertex’s fight club rule: Block new treatments to cystic fibrosis patients until Orkambi is reimbursed properly (Endpoints)
• Vaccine scandal like one in China have eventually led to reforms and safer drugs (South China Morning Post)
• Indo-China talks put on fast track to bring down drug approval timeline & import tariff on priority therapeutics (Pharmabiz)
• Italy's anti-vaccine push could spread around the world (Axios)
• Experts highlight Ebola vaccine progress and suggest next steps (NIH)
• Four new Congo Ebola cases as medics prepare experimental treatment (Reuters)
• Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries (JAMA)

• Advances In Treating Hep C Lead To New Option For Transplant Patients (KHN)
• The Large Hidden Costs of Medicare’s Prescription Drug Program (NYT)
• The congressional districts with the most opioids per person (Axios)
• A counter balance to Big Pharma at the ballot box (The Hill)
• ICER Weekly View 08-10-18 (ICER)
• Guest Post -- Antibody Drug Conjugates: The Patent Landscape for a New Class of Cancer Treatment (Patent Law Weblog)
• Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise? (Lachman Consultants)
• The US opioid crisis has 'peaked,' says one of the nation's leading health-care authorities (CNBC)
• Medicare Strike Force Targets Opioid Abuse in N.J., Philly (Bloomberg-$) (DOJ)
• Allergan Dodges Health Fraud Case as Court Tells Copycat ‘No’ (Bloomberg-$)
• Current and New Approaches to Making Drugs More Affordable (CVS Health)
• Researchers test potential anti-suicidal effects of drug (Baylor College of Medicine News)
• Using CRISPR for the ‘smaller wins,’ like making chemotherapy less toxic (STAT)

• FDA gives breakthrough status to Xolair for food allergies (PMLiVE)
• A landmark drug approval shows RNAi’s promise — even as it hints at its limits (STAT-$)
• Circassia announces Duaklir and Tudorza NDAs (The Pharma Letter)
• Mylan Launches First Generic for Adcirca Tablets (Press)
• FDA Accepts New Drug Application (NDA) to review Midazolam Nasal Spray, an investigational product for the acute treatment of seizure clusters (Press)
• Eyenovia’s EYN PG21 Trial Evaluating High-Precision Microdose of Latanoprost Demonstrates Robust Intraocular Pressure Lowering and Patient Usability (Press)
• Checkpoint Therapeutics Announces Clinical Data on EGFR Inhibitor CK-101 Selected for Late-Breaking Oral Presentation at IASLC 19th World Conference on Lung Cancer (Press)
• Stemline Therapeutics Announces that FDA Accepts ELZONRIS Biologics License Application (BLA) and Grants Priority Review (Press)
• 1st Patient Treated for Osteoarthritis Knee Pain in Sorrento Resiniferatoxin Phase 1B Trial Meets Both Safety and Efficacy Expectations (Press)
• 'Undruggable' cancers slowed by targeting growth signals (Press)

• Sensors to Smartphones Bring Patent Wars to Diabetes Monitoring (Bloomberg)
• Nevro Aims to Undo Boston Scientific Spinal Cord Therapy Win (Bloomberg-$)
• Ky. Court Nixes $21M Award In Unnecessary Pacemaker Suit (Law360-$)
• Thinking Big for the Smallest Patients: Innovation in Pediatric Technology (AAMI)
• Adherium launches over-the-counter digital asthma inhaler add-on and app in the U.S. (Fierce)
• GN announces new ‘premium-plus’ addition to hearing aid line (Fierce)
• SpaceLabs’ Arkon anesthesia system recalled again (MassDevice)
• Hologic pulls Vitalia handpieces, probes in light of FDA concerns over vaginal rejuv tech (MassDevice)
• Plaintiffs in J&J DePuy Ortho Pinnacle hip bellwether seek $246m in damages (MassDevice)
• Q2 Recalls Snapshot: Industry Sets Record Again With Most Quarterly Recalls Since '05 (Medtech Insight-$)
• User experience of instant blood pressure: exploring reasons for the popularity of an inaccurate mobile health app (Nature)
• In Vivo Sensors: More than a Space-Age Fantasy? (MD+DI)
• 6 AI Companies Set to Rock the Medtech World (MD+DI)
• 7D Surgical Receives FDA Approval For Cranial Surgery (Press)
• GI Dynamics Announces FDA Approval for EndoBarrier Pivotal Trial (Press)
• Wearable devices and mobile health technology: one step towards better health (Press)
• Blood test could detect kidney cancer up to 5 years earlier (Press)
• Genetic tools uncover cause of childhood seizure disorder missed by other methods (Press)
• New Study Investigates the Utility of Home Monitoring Using Masimo SET Pulse Oximetry to Screen Children with Down Syndrome for Risk of Obstructive Sleep Apnea Prior to Diagnostic Multichannel Sleep Studies (Press)
• Beltone Amaze: A New, Amazingly Advanced and Powerful Hearing Aid (Press)

• IBM Has a Watson Dilemma (WSJ)
• Will Courts Allow States to Regulate Drug Prices? (NEJM)
• During HIV infection, antibody can block B cells from fighting pathogens (NIH)
• ACI’s 32nd FDA Boot Camp – Boston Edition (FDA Law Blog)
• Senate Dems' midterm health care message: It's not just ACA repeal (Axios)
• 5 doctors and surgeons tell us what they really think about Medicare-for-all (Vox)
• Congress should listen to addiction patients — not corporate interests — about confidentiality (STAT)

• FDA Advisory Committee Calendar

• Field Safety Notice - 6 August to 10 August (MHRA)
• Updated: Early access to medicines scheme applications: pending, refused, granted (MHRA)
• Red Hand Letter on hydroxyethyl starch (HES) -containing drugs for infusion: New measures to strengthen existing limitations due to increased risk of renal dysfunction and fatality in critically ill or septic patients (BfArM)
• Dr Reddy's eyeing European market for cancer drug (Press Trust of India )
• Benzodiazepines are associated with increased risk of Alzheimer's disease (Press)

• Fierce competition in China’s nascent immuno-therapy cancer drugs market could compromise safety, say analysts (South China Morning Post)
• How Beijing’s strict compensation system fails the families of China’s vaccine injury victims (South China Morning Post)
• Korean pharmaceuticals invest more into functional food market (Korea Biomedical Review)
• Composite sputum patch patch was approved for marketing (CNDA)
• PMDA-ATC GMP Inspection Seminar 2018 (PMDA)

• Smart medical devices saving lives (The Hindu)
• CDSCO forms expert panel to evaluate manufacturing, purification, quality control & toxicological data of new phytopharmaceuticals (Pharmabiz)
• Government should focus on Healthcare innovation, not price capping (BioSpectrum)
• India Releases ‘Essential Reference Manual’ On Devices And IVDs (Medtech Insight-$)
• Area transplant communities ready for increasing organ donation rates? (Times of India)

• Essure contraceptive device: Update relating to current status (TGA)
• Fewer Australians are dying from hepatitis C, but thousands are still missing out on treatment (ABC News)

• Nuvo Pharma to buy 20 commercial products & infrastructure from Aralez Pharma (Pharmabiz)
• The Minister of Health announces an investment of $378M in more than 400 research projects across Canada (Canadian Institutes of Health Research)
• Align funding with innovations in health care to improve patient outcomes (Press)

• There Will Never Be an Age of Artificial Intimacy (NYT)
• Surgery centers don't have to report deaths in 17 states (USA Today)
• Individuals With HIV Are Twice as Likely to Develop Cardiovascular Disease, Study Finds (AJMC)
• Opening the ‘black box,’ Google DeepMind AI system diagnoses eye diseases and shows its work (STAT)