Recon: EC Approves 4th Infliximab Biosimilar

• J&J Loses Second Talc-Asbestos Trial and Damages May Grow (Bloomberg) (Fierce) (Reuters)
• Recro Pharma shares plummet after FDA rejects non-opioid pain shot (Reuters) (BioPharma Dive) (Endpoints)
• Medtronic tops estimates with fiscal Q4, 2018 results (MassDevice) (Star Tribune) (Reuters)
• Solicitor General Urges High Court To Take Up Merck's Fosamax Appeal (Law360-$) (STAT-$) (Lexology-$)
• Pfizer under pressure to resolve shortage of life-saving EpiPen (Financial Times)
• It Costs $685 Billion a Year to Subsidize U.S. Health Insurance (Bloomberg) (The Hill) (Axios)

• Novartis receives EU approval for biosimilar Zessly (Reuters) (PharmaTimes) (The Center for Biosimilars) (The Pharma Letter-$)
• Astellas cuts 600 positions in Japan as new CEO makes his mark (Fierce) (Endpoints)
• Venture Capitalists Put $260 Million Into New Chinese Biotech (Forbes) (Fierce) (Endpoints)
• India below Sudan on healthcare access (The Telegraph) (FirstPost) (Business Standard)
• As Nipah virus spread is suspected, government to compensate victims (CNN) (Reuters)
• U.S. biotechs to speed work on Nipah vaccine as virus hits India (Reuters)
• WHO: DRC Ebola outbreak on a 'knife's edge' as urban cases rise (Al Jazeera) (The Telegraph)
• Congo says Ebola cases have reached 30, warns against rumors (AP News) (Reuters)
• World Health Assembly delegates agree new five-year strategic plan (WHO)
• Seventy-First World Health Assembly update, 23 May (WHO)
• Development of antibiotics for children - towards a global approach (EMA)
• NIH begins testing Ebola treatment in early-stage trial (NIH)
• 50 Years Of Global Health Progress – Interview With IFPMA Head Thomas Cueni (Health Policy Watch)
• USTR calls on Mexico to improve pharmaceutical and medical device innovation and market access (Lexology-$)

• We're getting new treatments for 'a disease that once was definitely a death sentence' — but it comes with a big price tag (Business Insider) (BioPharma Dive) (Fierce)
• Biotech IPOs Roll On as Kiniksa, Scholar Rock Get $227M Combined (Xconomy)
• DEA gives some of Pfizer's injected narcotics allotment to competitors as production issues intensify shortages (Fierce)
• Novo Nordisk licenses kidney disease drug from Epigen (Fierce)
• Look out, J&J. Sun Pharma's Yonsa nod in prostate cancer puts Zytiga on notice (Fierce)
• FDA head worries drug companies will abandon making cheaper drugs (Washington Examiner)
• A career in biotech brought success. Then the birds came calling (STAT)
• Why was Theranos so believable? Medicine needs to look in the mirror (STAT)
• Are small companies carrying the complete response letter can? (EP Vantage)
• Vantage view – Why competitive bidding will be a hard task in Medicare (EP Vantage)
• Supreme Court Denies Cert. Petition Accusing Fifth Circuit of “Sabotage of Off-Label Enforcement” (FDA Law Blog)
• Kickback Convictions Don’t Mean Valeant Is Off The Hook (Law360-$)
• Doughnuts and Discounts — Changes to Medicare Part D under the Bipartisan Budget Act of 2018 (NEJM)
• Consequences of the 340B Drug Pricing Program (NEJM)
• Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions (KHN)
• Celgene Corporation Announces Additional $3 Billion Share Repurchase Authorization and Plans to Execute a $2 Billion Accelerated Share Repurchase Program (Press)

• AstraZeneca expands development deal with Bicycle (BioPharma Dive)
• Bloom bags cash, UCLA tech to treat epilepsy via the microbiome (Fierce)
• Neoadjuvant PD-1 Blockade in Resectable Lung Cancer (NEJM)
• Clementia adds phase II failure to its patent woes (EP Vantage)
• Calgary Researchers Discover a Novel Approach to Treatment of Inflammatory Bowel Diseases (IBD) Using Hydrogen Sulfide Technology (Press)

• Merck, Pfizer power tumor profiling firm Strata to $26M round (Fierce)
• Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB (Drug Delivery Business News) (Press)
• DOD Bars Mobile Devices From Secure Areas At Pentagon (Law360-$)
• Avinger wins FDA nod for next-gen Pantheris (MassDevice) (Press)
• FDA Approves Newest Generation of XIENCE Stent for Blockage in CAD (MD Magazine)
• Abbott's Tendyne device for mitral valve replacement demonstrates positive outcomes at 30 days in global study (Pharmabiz)
• Christine Aylward launches new firm called Magnetic Ventures (Axios)
• Renal denervation goes from Symplicity to complexity (EP Vantage)
• LuViva scanner could provide alternative to smear test (pharmaphorum)
• Company Ignores FDA’s Request to Cease Commercial Distribution (MedTech Intelligence)
• Determining Significant Vs. Nonsignificant Risk In Medical Devices (Med Device Online)
• Congress Continues Push on Medical Device Cybersecurity Mandates (Lexology-$)
• New tech could make prosthetic hands easier to use (Verdict Medical Devices)
• On the Marketing and Use of Pharmacogenetic Tests for Psychiatric Treatment (JAMA)
• This digital pill wants to make following your prescription easier (PBS NewsHour)
• It takes an ecosystem for a vibrant personal genomics industry to grow (MedCity News)
• Inside Geisinger Health System’s plan to offer DNA sequencing to patients (KHN)
• UPS Launches New Technology To Optimize Field Inventory For Critical Medical Devices (Press)
• Independent Stent Imaging Study Shows Excellent Healing Profile with Resolute Onyx DES in Complex Patients with Coronary Artery Disease (Press)
• New Medtronic Data Show Significant Blood Pressure Lowering Effect of Renal Denervation in Patients Taking Anti-Hypertensive Medication (Press)
• Synedgen Receives FDA 510(k) Clearance for Catasyn Advanced Technology Wound Hydrogel (Press)
• Zimmer Biomet Announces 510(k) Clearance for Zyston Strut Open Titanium Interbody Spacer System (Press)

• US FDA: No Additional Regulations for Medical Device OEMs and Third-party Service Providers (Emergo Group)
• Senate sends major VA reform bill to Trump's desk (The Hill) (Modern Healthcare) (AP News)
• The head of the National Cancer Institute on hopes for AI, the future of precision medicine, and big data (STAT-$)
• The Title X cuts are here (Axios)
• Democrats running for Maryland governor pledging to support a state individual mandate for health care (The Baltimore Sun)
• Subscribing to Your Patients — Reimagining the Future of Electronic Health Records (NEJM)
• Higher Lung Cancer Incidence in Young Women Than Young Men in the United States (NEJM)
• The Comprehensive Primary Care Initiative: Effects On Spending, Quality, Patients, And Physicians (Health Affairs)
• Good News For Patients: Trump Won't Dramatically Lower Drug Prices (Forbes)
• All of Us Research Program Issues Funding Announcement for Genome Centers (NIH)
• Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (FDA)
• The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices (US HELP Committee)

• FDA Advisory Committee Calendar

• NICE rejects Chiesi’s Lamzede (PharmaTimes)
• Tax rises needed to boost health and social care funding (PharmaTimes)
• Helsinn invests to safeguard the quality and authenticity of its products (The Pharma Letter)
• France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States (Lexology-$)
• Ireland Is Holding a Once-In-a-Generation Abortion Referendum Tomorrow. Here's What's at Stake (Fortune)
• BioGX Launches Six CE-Mark Tests for Meningitis and Antibiotic Resistance (Press)

• The First AHWP Technical Committee Meeting in 2018 held in Beijing (CFDA)
• Jiao Hong,CNDA Commissioner,meets Rafael Perez Christian,the Director General of the Center for State Monitoring of Medicines,Medical Equipment and Devices of Cuba(CECMED) (CFDA)
• Jiao Hong,CNDA Commissioner,meets Mr.Alain Merieux,President of Foundation Merieux and Institute Merieux,France (CFDA)
• China says finds no clues to explain U.S. sonic incident (Reuters) (NYT) (WSJ)
• Initiative for the Compilation of Database-stored Data and Provision of Information concerning Pediatric Drugs (PMDA)

• Soon a text message will be enough to spot fake medicines (Economic Times)
• Whether It's Health or Crops, India Isn't Doing Social Insurance Right (The Wire)
• Delhi govt to set up licensing authority to monitor & streamline functioning of de-addiction centres (Pharmabiz)
• Meeting of DTAB Sub Committee for examining the 344 FDCs + 05 FDCs and to provide hearing to the petitioners/appellants including AIDAN-regarding (CDSCO)
• Special operations to prevent and detect illegal manufacturing of (API, formulations) and import of Oxycotin in India - regarding. (CDSCO)
• Pfizer Inc recalls 1.8 million vials of antibiotics (Economic Times) (Hindustan Times)

• Public patients waiting twice as long for elective surgery, hospitals data reveals (The Guardian)
• Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices (TGA)
• Black Triangle Scheme: Information for sponsors (TGA)
• Consultation: miconazole and fluconazole: proposed advisory statements for medicines (TGA)
• Consultation: Sedating antihistamines: proposed additional advisory statements for medicines (TGA)
• TGA presentation: Update on the therapeutic goods advertising reforms (TGA)
• Inaugural Industry Forum on Good Manufacturing Practice (GMP) (TGA)
• Submissions received: Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response (TGA)

• Federal panel urging Canada to ramp up efforts to collect blood plasma (The Canadian Press)
• Statement from Health Canada - Final Report of the Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada (Health Canada)
• Lynparza - Notice of Compliance with Conditions - Qualifying Notice (Health Canada)

• OIE declares Brazil free of foot-and-mouth with vaccination (Reuters)
• Anvisa presents system to monitor prosthetics (ANVISA)

• A Pioneering Heart Surgeon’s Secret History of Research Violations, Conflicts of Interest and Poor Outcomes (ProPublica-Houston Chronicle)
• New Cancer Treatments Lie Hidden Under Mountains of Paperwork (NYT)
• Why the U.S. never got universal health care (Axios)
• Sleep-tracking wearables and apps no substitute for sleep tests (Reuters)
• A focus on cost instead of value threatens the future of personalized medicine (STAT)
• He went to an in-network emergency room. He still ended up with a $7,924 bill. (Vox)
• Can VR training churn out better surgeons? (MedCity News)