Regulatory Focus™ > News Articles > 7 > Recon: 11 Babies Die in Dutch Viagra Trial

Recon: 11 Babies Die in Dutch Viagra Trial

Posted 24 July 2018 | By Ana Mulero 

Recon: 11 Babies Die in Dutch Viagra Trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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-$) (MassDevice)
  • How the Trump Administration Is Browbeating Big Pharma on Drug Prices (NYT)
In Focus: International
  • Eisai-Biogen to advance Alzheimer's drug, provide fresh hope (Reuters) (Endpoints)
  • GSK banks on promising data from its PhIII Gemini program to stare down Gilead on HIV — but there are plenty of skeptics (Endpoints) (Reuters) (Fierce)
  • Eleven babies die after Dutch women given Viagra in drug trial (The Guardian) (Endpoints)
  • Ebola outbreak in DRC ends: WHO calls for international efforts to stop other deadly outbreaks in the country (WHO) (AP News)
  • R&D based Indian pharma players secure 125 final ANDA approvals from US FDA during first half of 2018 (Pharmabiz)
  • India Pharma Q1 Preview: Home Gains But Subdued US Growth (Scrip-$)
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • 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)
India
  • 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)
Australia
  • 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)
Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

Categories: Recon

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe