Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Finds DMD Drug Data Not Persuasive (25 November 2015

Regulatory Recon: FDA Panel Finds DMD Drug Data Not Persuasive (25 November 2015

Posted 25 November 2015 | By Zachary Brennan 

Regulatory Recon: FDA Panel Finds DMD Drug Data Not Persuasive (25 November 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Hope you have a happy Thanksgiving tomorrow. Regulatory Focus will not be publishing Thursday or Friday. Enjoy the weekend.

In Focus: US

In Focus: International

  • Boy dies of Ebola in Liberia, first fatality in months (Reuters) (Washington Post)
  • Brazilian courts tussle over unproven cancer treatment (Nature News)
  • Government lobbying with unregulated markets to accept Indian drug standards (Economic Times)
  • France detects first bird flu outbreak in years (Reuters)
  • NHS could be offered incentives to switch to biosimilars (Pharmaphorum)
  • FDA Warns Sandoz, Dr. Reddy’s Indian Sites Over Data Integrity Violations (Focus)
  • Filgrastim biosimilar is first Latin copy biologic, says Brazil (BioPharma-Reporter)

US: Pharmaceuticals and Biotechnology

  • Why Many Cancer Drugs Don't Have To Cost So Much (Forbes)
  • Roundup of upcoming BPCIA Cases (Big Molecule Watch Blog)
  • Turing to Discount Daraprim Anti-Parasitic Drug as Much as 50% (WSJ-$)(Reuters)
  • Shire prepares to make new bid for Baxalta (Reuters) (FierceBiotech) (Bloomberg)
  • Philidor 2.0: Valeant and Stephen King play Chess with a lot of pharmacies (Bronte Capital)
  • Shire Blocks Par From Selling Adderall Generic (Law360-$)
  • Working Together: The Path Forward to Ensuring Patient Access to Innovative Therapies (Morning Consult)
  • McClellan Suggests Adding Drug Spending To Alternative Pay Models (InsideHealthPolicy-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Stakeholder-Driven Comparative Effectiveness Research (JAMA)
  • FDA Ruffles Feathers by Delaying DMD Tx Review (MedPage Today)
  • Two decades of new drug development for central nervous system disorders (Nature Reviews)
  • Pfizer Reports Top-Line Results from a Phase 3 Study of LYRICA (Press)
  • Indivior Receives Complete Response Letter from FDA Not Approving Naloxone Nasal Spray New Drug Application for Opioid Overdose (Press)
  • Stimulant medications may harm sleep for kids with ADHD (Reuters) (Cochrane)
  • Research raises questions over ADHD drug effects (Reuters)
  • Allergan and Rugen Therapeutics Announce Collaboration to Discover and Develop Ground-Breaking Medicines to Treat Autism Spectrum Disorders and Obsessive-Compulsive Disorders (Press)
  • Merck KGaA, Darmstadt, Germany, and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products (Press)
  • Teva and Heptares Enter Agreement to Discover and Develop Novel, Small-Molecule CGRP Antagonists for Treatment of Migraine (Press)

US: Medical Devices

  • Doctor on a quest to save medical devices from hackers (Wired)
  • Theranos: A Cautionary Tale (Mass Device)
  • FDA considers greater oversight of laboratory developed tests (Mass Device) (Fierce)
  • TU Delft: Developing Surgical Tools for Snaking Through The Body (MedGadget)
  • Dell gets into medical imaging, inks deal with Zebra (Mass Device)
  • Dilon inks distro deal with GE Healthcare for breast imaging system (Mass Device)
  • Fujifilm Unveils Next Generation Digital Radiography: FDR Visionary Suite at RSNA 2015 (Press)

US: Assorted and Government

  • Inside the Pentagon’s biotech strike force (STAT)
  • FDA releases four draft guidances on sunscreen (FDA Law Blog)
  • API sourcing leads US Gov to label Carlsbad's Acyclovir tablets as made in Asia (In-Pharma)

Upcoming Meetings and Events              


  • Europe's research chief wants scientists to speak up (Science)
  • INTERVIEW: Not All Over Once New EU Reg Texts Are Adopted, Says EDMA Chief (Clinica-$)
  • Pfizer Receives European Approval to Expand Use of XALKORI (Press)


  • Overpriced medical devices: Government asks companies to submit maximum retail price details (Economic Times)
  • India's first MRI machine to be out in market by 2018 (Economic Times)


  • Zai nabs China rights to T790-mutation NSCLC drug in Hanmi agreement (BioWorld-$)

Other International

  • Moroccan firms eye growing Ethiopian pharma market (PharmaAfrica)
  • Australian Public Assessment Reports for prescription medicines (TGA)
  • Revisions of PRECAUTIONS (FY2015) (Japan’s PMDA)

General Health and Other Interesting Articles

  • With This Genetic Engineering Technology, There’s No Turning Back (MIT Tech Review

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.

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