Recon: Biogen’s Spinraza Too Costly for Britain; China Invalidates Patent on Gilead Hepatitis C Drug

• New York sues OxyContin maker Purdue Pharma over opioids (Reuters)
• Tech Giants Pledge to Ease Patient, Provider Access to Health Data (WSJ) (The Hill)
• Flagship Pioneering’s Sigilon gets a new CEO (STAT-$) (Endpoints) (Fierce)
• Acorda Therapeutics CTO Leaves To Helm Unnamed Biotech Company (BioSpace) (Fierce)
• Carl Icahn Backs Off Cigna-Express Scripts Deal (Forbes) (Bloomberg) (WSJ)
• Genentech Wins Attorneys’ Fees in Kadycla Patent Lawsuit (Bloomberg-$) (Law360-$)
• After Cohen payment scandal, Novartis unveils new ethics chief (PMLiVE) (Endpoints)
• AIDS health group brings Gilead patent skirmish to Supreme Court (Fierce) (The Pharma Letter)
• Drugmakers say R&D spending hit record in 2017 (BioPharma Dive)

• Biogen's pricey muscle drug Spinraza too costly for Britain (Reuters) (Endpoints) (PMLiVE)
• Bayer targets COPD in a new discovery alliance with Haplogen, Evotec (Endpoints) (Fierce)
• Profusa nets $45M to sell implanted tissue oxygen sensors in the EU (Fierce) (MobiHealthNews)
• Gilead patent for its hepatitis C drug is invalidated by Chinese authorities (STAT-$) (Endpoints)
• Congo starts using experimental Ebola treatment (Reuters)
• Infant Diarrhea Deaths Drop Sharply in Malawi Due to Rotavirus Vaccine (GEN)
• Canada must guard against unrestricted drug exports to the US (Policy Options)
• GE Healthcare Becomes Member of AdvaMed to Advance Medical Technology Globally (AdvaMed)

• Transparent pharmacy benefits: a path to rational drug costs (STAT)
• CVS, Express Scripts provide a rare moment of transparency on rebate profits (Fierce)
• New Disclosures Show CVS and Express Scripts Can Survive in a World Without Rebates. Are Plan Sponsors Now the Real Barrier to Disruption? (Drug Channels)
• Drug price reforms still don't scare Wall Street (Axios)
• The Terminally Ill Need More Than the ‘Right to Try’ (WSJ)
• Does Tiny Iovance Deserve To Ride The T-Cell Wave? (Forbes)
• New drugs so pricey they need new payment plans (Politico)
• They Thought Hemophilia Was a ‘Lifelong Thing.’ They May Be Wrong. (NYT)
• Fed. Circ. Wrong On HIV Drug Patent Challenge, Justices Hear (Law360-$)
• Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness (JAMA)
• Death Reports Make The Opioid Crisis Personal For Doctors (Hartford Courant)
• Drug companies don’t want to be involved in executions, so they’re suing to keep their drugs out (The Washington Post)
• The Power of a Simple Letter In the Opioid Epidemic (Fortune)
• Pfizer Oncology loses its CMO to Allergan as cancer exec Charles Hugh-Jones makes a career leap (Endpoints)
• Ex-Pfizer exec Geno Germano joins nanoparticle startup Elucida Oncology as CEO (Endpoints)
• Louisiana Pursues Up-Front Pay Model for Hepatitis C Drugs (Bloomberg-$)
• Drug Pricing Policy: HHS Introduces Step Therapy In Medicare Advantage (Health Affairs)
• Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (FDA)

• Tdap vaccine given to pregnant women did not increase risk of autism in children, study says (The Washington Post)
• Has Amyloid-Based Research Turned The Corner? (Forbes)
• Scientists Cracked a Deadly DNA Puzzle. Then Came the Hard Part (Bloomberg)
• Realm Therapeutics shares crater — again — on a failed PhII atopic dermatitis study (Endpoints)
• Whole Exome Sequencing Identifies New Alzheimer’s-Related Genes (GEN)
• No Gain with Antipsych Meds Switch in Schizophrenia (MedPage Today)
• Cetuximab with radiation found to be inferior to standard treatment in HPV-positive oropharyngeal cancer (NIH)
• Issuance of Priority Review Voucher; Rare Pediatric Disease Product (FDA)
• One antiplatelet drug after heart valve replacement (Press)
• Motif Bio Announces FDA Acceptance of New Drug Application with Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections (Press)
• FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans (Press)
• Entasis Therapeutics Announces Positive Topline Results from Phase 2 Trial of ETX2514SUL in Patients with Complicated Urinary Tract Infections including Acute Pyelonephritis (Press)

• A Harvard Scientist Thinks He Has a Gene Test for Heart Attack Risk. He Wants to Give It Away Free. (Forbes)
• Untitled letters for HIV test kits (FDA)
• GYNs Sue Cynosure Over 'Vaginal Rejuvenation' Laser (Law360-$)
• Not all women eligible for breast cancer gene tests are getting them (Reuters)
• Doctors may not explain pros, cons of lung cancer screening (Reuters)
• VisualDx gets NASA grant to build diagnosis tool for deep space missions (MobiHealthNews)
• Rep. Mia Love calls for repeal of the medical device tax helping to fund Obamacare, saying it hurts Utah firms (including one of the state’s biggest political donors) (The Salt Lake Tribune)
• Despite FDA Caution, Doctors Say Lasers May Help With Vaginal Pain And Dryness (NPR)
• Study slams FDA’s ‘fast-track’ approval process (Medical Design & Outsourcing)
• Lessons for physicians from ‘The Bleeding Edge’: If you see something, say something (STAT)
• FDA’s IVD TA: It’s Not Just Technical Assistance (FDA Law Blog)
• Study Finds Most Wearable Devices Lack Independent Validation (AAMI)
• BioSig Technologies Announces FDA 510(k) Clearance for PURE EP System (Press)
• Inova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR (Press)
• MolecuLight Inc.'s first-of-its-kind handheld fluorescence imaging device receives FDA De Novo clearance for US wound care market (Press)
• Ivantis Announces FDA Approval for Its Innovative Hydrus Microstent Device for Minimally Invasive Glaucoma Surgery (MIGS) (Press)
• PaceMate Launches State’s First Automated Remote Cardiac Device Monitoring System at Arizona Heart Rhythm Center (Press)

• Massachusetts considers bill aimed at improving patient reimbursement for clinical trial expenses (Fierce)
• Trump’s Sabotage of Obamacare Is Illegal (NYT)
• States Push Back Against Dismissal Bids In Opioid MDL (Law360-$)
• Feds Urge States To Encourage Cheaper Plans Off The Exchanges (KHN)
• Nebraska Set to Use Drug Cocktail That Includes Fentanyl in Execution Tuesday (WSJ)
• Teens hooked by vaping: FDA weighing a ban on flavored e-cigarette liquids (USA Today)
• Bayer stock plunges after jury awards man $289 million in Roundup cancer trial (The Washington Post)
• The real Chris Collins scandal: lax conflict-of-interest rules in Congress (STAT)
• To lower state drug costs, the National Governors Association is promoting several ideas (STAT-$)
• New NIH reference book is one-stop resource for diabetes medical information (NIH)
• World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads Contamination (FDA)

• FDA Advisory Committee Calendar

• Four new medicines cleared for use on NHS Scotland (PharmaTimes)
• EMA scales back transparency initiatives because of workload (The BMJ)
• German Ministers Call, Too, For Longer EU MDR/IVDR Transition – But Is It A Can Of Worms? (Medtech Insight-$)
• Updated: Buying medical devices for personal use (MHRA)
• Artificial placenta created in the laboratory (Press)

• China, Korea overtaking India in vaccine exports: Experts (Economic Times)
• Parkinson’s drug Azilect beats market leader Stalevo (Korea Biomedical Review)
• English Translation of Review Report: Xofluza (PMDA)
• New Drug Application Submitted in Japan for INTUNIV (guanfacine hydrochloride extended release) in Adults with ADHD (Press)
• AVEO Announces Acceptance of CANbridge Investigational New Drug Application for CAN017 (AV-203) Trial in Esophageal Squamous Cell Cancer (ESCC) in China (Press)
• CANbridge Life Sciences Receives Approval to Commence CAN017 Ib/III Trial in Esophageal Squamous Cell Cancer (ESCC) In China (Press)

• Mohali: Two pharma firm owners booked for misleading FDA (Indian Express)
• India's Sun Pharma quarterly profit beats estimates (Reuters)
• Indian players must look to deals to grab major share of global biosimilar market, says analyst (The Pharma Letter-$)
• Experts allay fears of Indian patients as valsartan drug recall widens over carcinogenic chemical (Pharmabiz)
• NPPA has fixed/revised ceiling prices/retail prices of 92 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 13.08.2018. (NPPA)

• Major Australian EHR rollout approaches halfway mark (Healthcare IT News)

• Canadian pharmacist fined for routinely accessing health records of acquaintances (Healthcare IT News)
• Product Monograph Brand Safety Updates (Health Canada)
• Summary of Cancellation for AVASTIN (Health Canada)
• Summary Basis of Decision - Guardian Connect Continuous Glucose Monitoring System (Health Canada)

• Surprise hospitals bills are everywhere (Axios)
• It’s Early Days for the Use of AI in Medicine (WSJ)
• Study Finds Childhood Diabetes Lowers Lifespan by 18 years (GEN)
• To Keep You Healthy, Health Insurers May Soon Pay Your Rent (Forbes)
• 'Back-and-forth' conversations with young kids may aid brain development (Reuters)