Recon: 11 Babies Die in Dutch Viagra Trial

• Eli Lilly plans listing of animal health unit (Financial Times) (Reuters) (WSJ) (Bloomberg)
• Roche halts price hikes for 2018—but only after it already raised them twice (Fierce)
• Following some clean sweeps in PhIII, AbbVie gets an FDA OK on its top-10 blockbuster prospect Orilissa (Endpoints) (Business Insider)
• Biogen beats estimates on Spinraza sales, raises forecast (Reuters) (Endpoints) (Fierce) (STAT)
• Bayer Can't Keep 16 Suits Over Essure Injuries In Fed. Court (Law360-$) (MassDevice)
• How the Trump Administration Is Browbeating Big Pharma on Drug Prices (NYT)

• Eisai-Biogen to advance Alzheimer's drug, provide fresh hope (Reuters) (Endpoints)
• GSK banks on promising data from its PhIII Gemini program to stare down Gilead on HIV — but there are plenty of skeptics (Endpoints) (Reuters) (Fierce)
• Eleven babies die after Dutch women given Viagra in drug trial (The Guardian) (Endpoints)
• Ebola outbreak in DRC ends: WHO calls for international efforts to stop other deadly outbreaks in the country (WHO) (AP News)
• R&D based Indian pharma players secure 125 final ANDA approvals from US FDA during first half of 2018 (Pharmabiz)
• India Pharma Q1 Preview: Home Gains But Subdued US Growth (Scrip-$)
• Millions to opt out of My Health Record as backlash builds (Sydney Morning Herald) (ABC News)
• Jiao Hong, Commissioner of CNDA, meets Trevor Mundel,the President of the Global Health Program, Bill and Melinda Gates Foundation (CFDA)
• Antibiotic-resistant infections appeared after surgery. Were they transmitted by leeches? (STAT)

• Preclinical biotech companies are having an IPO bonanza. What’s the draw for investors? (STAT-$)
• PhRMA lobby spend grows to $15.5M in the first half of 2018 (Fierce)
• Top 10 pipeline blowups, setbacks and snafus in H1 2018 (Endpoints)
• Approvals Look Sweet in July Already (Lachman Consultants)
• Will Patients Benefit From Pharma's Pause on Drug Price Increases? (The Center for Biosimilars)
• Glaxo’s New Research Chief Loves Big Pharma. Now He Has To Fix It (Forbes)
• Building a New Drug Wholesaler Compensation Model: What Happens as Brand Inflation Slows? (Drug Channels)
• Merck & Co. Partners with Sutro on Cytokine Derivatives for Cancer, Autoimmune Disorders (GEN)
• Chiesi Gains U.S. Rights to Protalix' Phase III Fabry Disease Candidate PRX-10 (GEN)
• Pharma and AI? Let's try augmented intelligence first (BioPharma Dive)
• How Often Do Urgent Care Clinics Offer Antibiotics When They Shouldn't? (Forbes)
• Medicare patients may lower drug costs by not using their insurance (Reuters)
• Walmart drug program cheaper for many Medicare patients (NBC News)
• Bulk Drug Substances Used in Compounding (FDA)
• Compounding Laws and Policies (FDA)
• Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (FDA)
• Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act (FDA)
• GSK and Adaptimmune Complete Transition of NY-ESO SPEAR T-cell Therapy Program to GSK (Press)

• Adherence to PrEP, the HIV prevention drug, is low. A new study suggests a pill with a tiny sensor might help (STAT)
• Market slacker Celgene does something good for a change, looking to turn the corner on past mishaps (Endpoints)
• Merck posts 96-week doravirine HIV data as PDUFA date nears (Fierce)
• Immune responses from Johnson & Johnson's 'mosaic' HIV shot last 1 year: study (Fierce)
• Could Viruses Attacking The Microbiome Be Responsible For Inflammatory Bowel Disease? (Forbes)
• FDA Issues Letter Decision on Generic SUBOXONE 180-Day Exclusivity; It’s a Doozy! (FDA LAw Blog)
• Aldeyra Therapeutics Announces First Patient Enrolled in Sjögren-Larsson Syndrome Pivotal Phase 3 Clinical Trial (Press)
• DPP8/9 Inhibition - The Primary Mechanism of BioXcel Therapeutics’ Lead Immuno-Oncology Asset, BXCL701, Highlighted in Peer-Reviewed Journal (Press)
• Celyad Announces FDA Acceptance of IND Application for CYAD-101, a First-in-Class Non-Gene Edited Allogeneic CAR-T Candidate (Press)
• Biohaven Receives FDA May Proceed Letter And Initiates Phase 2/3 Clinical Trial Of Trigriluzole (BHV-4157) In Alzheimer's Disease (Press)

• Amplifon picks up Spanish hearing aid retailer for $618M (Fierce) (Reuters)
• Trump administration supports repeal of Obamacare's tax on medical devices (Washington Examiner)
• Precision Medicine Success Hinges On Diagnostics' Clinical Utility (Forbes)
• 1st Circ. Wonders Why FDA Should Not Decide Eyedrop Suit (Law360-$)
• Enzyvant and PerkinElmer to develop gene test for ultrarare Farber disease (Fierce)
• Clinical Innovations hires BD’s Richard Ji as VP of operations (Fierce)
• FDA approves Wisconsin plant for NorthStar Medical’s RadioGenix imaging agent (MassDevice)

• Assessment of Pragmatism in Recently Published Randomized Clinical Trials (JAMA)
• Senate Confirms Robert Wilkie as Veterans Affairs Secretary (NYT)
• NIH renews NeuroNEXT for neurological clinical research (NIH)
• Congress Passed VA Bill but Now Debates How to Pay for It (WSJ)
• House Passes Four Bipartisan Bills to Advance Public Health (E&C Committee)
• Massachusetts to probe e-cigarette maker Juul over sales to minors (Reuters)
• NJ Justices Won't Review OptumRx Bid To Revive $6B Deal (Law360-$)
• Google is mulling a new market for Nest smart home products: seniors (CNBC)
• Former Cleveland Clinic CEO Toby Cosgrove goes to Google (Modern Healthcare)
• Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for Comments (FDA)

• FDA Advisory Committee Calendar

• Out with the old… AZ sells European rights to Atacand (pharmaphorum)
• Cannabis-derived medicinal products recommended to be available on prescription (Gov UK)
• HPV vaccine to be given to boys in England (Gov UK)
• Medicines and Healthcare products Regulatory Agency board member expenses from January to March 2018 (MHRA)
• Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2017 to 2018 (MHRA)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018: CVMP adopts revised guidance on assessment of the risk to public health from resistance due to use of antimicrobials in food-producing animals (EMA)
• VITROS XT 7600 Integrated System from Ortho Clinical Diagnostics Receives CE Mark, Bringing Innovative New Approach to Clinical Lab Management (Press)

• Chinese vaccine firm hit with probes as Beijing seeks to tamp down outrage (Reuters)
• Pfizer Korea stops recruitment procedure (Korea Biomedical Review)
• Bristol-Myers Squibb, Tsinghua University pen drug discovery pact (Fierce)
• Korea to invest W42b in next-gen medical devices powered by AI, robotic (The Korea Herald)
• China's New Medical Device Regulations Bring Big Changes (Law360-$)
• Oramed Granted Japanese Patent for GLP-1 Analog Capsule (Press)

• Pharma hiring may stay muted this year (Economic Times)
• Ceiling of drug prices helped save Rs 11,463 crore to public: Government (Economic Times)
• CDSCO releases artwork guidelines for compliance with label change norm (Pharmabiz)
• NPPA directs 15 cos manufacturing & importing primary, revision knee system to furnish price data by July 30, 2018 (Pharmabiz)
• Promotion of innovation & start up business in India in Pharmaceutical sector (CDSCO)

• Advisory Committee on Vaccines meeting statement, Meeting 8, 30 May 2018 (TGA)
• Opium contaminated with lead poisons two in Melbourne and leaves hospitals on alert (Australian Associated Press)
• 2018 a watershed year for Australian technology (The Australian)
• AVITA Medical Announces Results of Extraordinary General Meeting (Press)

• Canadians invited to share their views with the Advisory Council on the Implementation of National Pharmacare (Health Canada)
• Proposed class-action lawsuit filed after blood pressure medication recalled (CTV News)

• For Scientists Racing to Cure Alzheimer’s, the Math Is Getting Ugly (NYT)
• Record Investments, But Few Exits in Health-Care Services (WSJ)
• When Sharks Attack Lung Disease, And More Science You Won't Learn On 'Shark Week' (Forbes)
• Are embryos people? The answer will determine the future of reproductive medicine (STAT)
• Illumina’s founding scientist launches software startup to track fast-mutating hospital bugs (Endpoints)