Regulatory Recon: Merck Says June Cyber Attack Led to Lower Guidance; Roche Leukemia Drug Picks Up Breakthrough Designation (28 July 2017)

Posted 28 July 2017 By Michael Mezher

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

In Focus: US

  • US House panel spotlights use of FDA rules to slow generic drugs (Reuters) (Pink Sheet-$) (FDA News-$)
  • GOP's shocking fail: What happened and what's next (Politico) (NYTimes)
  • McCain's Vote Provides Dramatic Moment in 7-Year Battle Over Obamacare (NYTimes)
  • FDA Updates on Digital Health Plans, Software Pre-Certification Pilot (Focus)
  • Merck profit beats as Keytruda sales soar, expenses drop (Reuters)
  • Merck admits cyberattack is having an impact on research, manufacturing — we're just not sure how big (Endpoints) (Financial Times)
  • Amgen gets fast FDA review for adding heart benefits to cholesterol drug label (Reuters) (Press)
  • Roche leukaemia drug gets FDA breakthrough therapy designation (Reuters)
  • CheckMate-227: Bristol-Myers Squibb has a MYSTIC-sized problem on its hands (Endpoints)
  • AstraZeneca trial results are 'damaging' to management credibility (STAT 1, 2) (The Guardian)
  • AstraZeneca chief strikes defiant tone after drug disappointment (Financial Times)
  • J&J sews up an expanded vaccine pact with Bavarian Nordic, paying $43M for HIV, hep B projects (Endpoints) (Fierce)
  • United Therapeutics in Settlement Talks With Justice Department (WSJ)
  • AbbVie's profit beats on Humira, Imbruvica demand (Reuters)
  • Revlimid drives Celgene profit beat; raises EPS forecast (Reuters)
  • Revlimid boosts survival in myeloma patients post-transplant (PharmaTimes)
  • Alexion posts higher second-quarter earnings on strong Soliris sales (Reuters)
  • Obamacare's medical device tax — and how it became a repeal target — explained (Vox)

In Focus: International

  • Hepatitis drugs more affordable but disease still deadly: WHO (Reuters) (WHO)
  • The global rivalry for top scientific talent in biopharma R&D is about to get a lot hotter (Endpoints)
  • Astellas Reports First Quarter FY2017 Financial Results (Press)
  • South Korean Top Health Regulators Take Office (Pink Sheet-$)
  • Key role for French cluster in regenerative medicine project (PMLive)
  • Audit exposes gaps in pharma's promises on trial transparency (PMLive)
  • EU approves CV benefit claim for Novo's Victoza (PharmaTimes)
  • European Regulatory Roundup: EMA Adopts Revised First-in-Human Trial Guidance; UK Appoints Industry Veteran Ahead of Negotiations with Pharma (Focus)
  • NICE nod for Allergan's Truberzi for IBS-D (PharmaTimes)
  • Celltrion Healthcare jumps 10% on debut in Seoul (Financial Times)

Pharmaceuticals & Biotechnology

  • GSK's Moncef Slaoui joins the board at Moderna; Aduro promotes van Elsas to CSO (Endpoints)
  • Biotech billionaire Soon-Shiong picks up rights to CytRx's troubled cancer drug (Endpoints)
  • FDA grants priority review to Kaleo's auto-injector for infants, kids (Drug Delivery)
  • Vaccine lessens severity of whooping cough infections (Reuters)
  • US Drug Prices And R&D, Take 2: A Reply To Grabowski And Manning, And To Light (Health Affairs Blog)
  • OTC Monograph User Fee Goals Document Beats Authorization To Finish Line (Pink Sheet-$)
  • FDA's Oncology Center Of Excellence On Equal Terms With CDER In New Org Chart (Pink Sheet-$)
  • Shooting for the moon: The National Cancer Institute's Formulary (Pharmafile)
  • Orphan Drug Development May Be Well-Suited To Digital/Wearables (Pink Sheet-$)
  • What's powering pharma toward the next digital frontier? One expert has an idea (Fierce)
  • Servier licenses Galapagos' phase 1 osteoarthritis drug  (Fierce)
  • ICER plots drug review topics for 2018 (PharmaLetter-$)
  • FDA Taking Nominations for List of Difficult-to-Compound Drugs (FDANews-$)
  • Upcoming events – FDA approvals due for Maviret and Besponsa (EP Vantage)
  • Broad scientists show how 1 bad gene takes a toll on 5 vascular diseases (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Samumed Successfully Completed 52-Week Phase 2 Study for Treatment of Osteoarthritis of the Knee (Press)
  • ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder (Press)
  • Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR® NECTAR (barium sulfate) Oral Suspension (Press)
  • Advanced Accelerator Resubmits Nda For Neuroendocrine Tumor Candidate (BioCentury)

Medical Devices

  • Boston Scientific warns on fluke S-ICD death (MassDevice)
  • The Challenges of Developing Ultra-Sensitive Diagnostic Assays (MDDI)
  • Quantel Medical Receives FDA Approval for Easyret Photocoagulator Laser (Press)

US: Assorted & Government

  • U.S. Senator expands opioid probe to distributors, drugmakers (Reutes)
  • FDA announces plans to slash nicotine levels in cigarettes (STAT) (FDA)
  • Sanofi Asks To Go Solo With Its EpiPen Fight Against Mylan (Law360-$)
  • Causation Testimony Excluded as "Unhelpful" and "Unreliable" in Heart-Lung Machine Death Case (Drug & Device Law)
  • Regeneron Pharmaceuticals, Inc. v. Merus N.V. (Fed. Cir. 2017) (Patent Docs)
  • Deregulatory Agenda Notwithstanding, the Enforcement Side of the House is Open for Business (FDA Law Blog)

Upcoming Meetings & Events

Europe

India

  • India: Draft Essential Principles for Medical Device Safety and Performance Out for Comment (Emergo)
  • Panacea Biotec, US's Bionpharma join hands for 7 drugs (Economic Times)

Canada

  • Consultation on Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products (Health Canada)

Australia

  • New hepatitis C drug to be subsidized in Australia (PharmaLetter-$)
  • Labelling changes: information for health professionals (TGA)
  • Gadolinium-based contrast agents for MRI scans (TGA)
  • Consultation: Alignment with European medical device regulatory framework (TGA)
  • Consultation: Nomenclature of Biological Medicines (TGA            )

Other International

  • Swaziland Nears HIV Containment Goals (Medpage)

General Health & Other Interesting Articles

  • Hit or myth? Understanding the true costs and impact of cybersecurity programs (McKinsey)
  • Slug slime inspires new kind of surgical glue (Reuters)
  • Immune system may mount an attack in Parkinson's disease (NIH)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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