Regulatory Recon: Valeant's Ties to Specialty Pharmacy Scrutinized, Alexion Wins Priority Review Voucher (26 October 2015)

Posted 26 October 2015 | By Michael Mezher 

Regulatory Recon: Valeant's Ties to Specialty Pharmacy Scrutinized, Alexion Wins Priority Review Voucher (26 October 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Valeant and Pharmacy More Intertwined Than Thought (WSJ-$)
  • Valeant sets up panel to look into specialty pharmacy association (Reuters)
  • The Pawn Isolated: Valeant, Philidor and the Annals of Fraud (SIRF)
  • Alexion Wins Priority Review Voucher for Strensiq Approval (FierceBiotech) (Reuters) (FDA) (SCRIP-$)
  • BioDelivery's opioid treatment wins FDA approval (Reuters) (Press)
  • Convenient timing, Shkreli: Turing’s epilepsy drug gets fast-tracked by FDA (MedCityNews)

In Focus: International

  • WHO experts signal victory over one of three polio strains (Reuters)
  • IMDRF To Strike Pre And Postmarket Balance In Plan That Mirrors EU And US Priorities (SCRIP-$)
  • World's first malaria vaccine delayed as WHO experts urge caution (Reuters) (NYTimes)
  • Putin's New Censorship Rules Will Weaken Russian Science (Forbes)

US: Pharmaceuticals and Biotechnology

  • Further Allegations of Misconduct Plague Valeant’s Pharmacies in California (ProPublica)
  • J&J's cancer drug finally wins FDA approval after 6 years of delay (FierceBiotech)
  • BioDelivery's opioid treatment wins FDA approval (Reuters)
  • FDA approves Janssen’s Yondelis for advanced soft tissue sarcomas (PharmaLetter-$)
  • Why "anti"-vaccination and why not "anti"-antibiotic overuse? (Forbes)
  • IUDs and Hormonal Implants Remain Underused Contraceptives (NYTimes)
  • Vertex and CRISPR Therapeutics Establish Collaboration to Use CRISPR-Cas9 Gene Editing Technology to Discover and Develop New Treatments for Genetic Diseases (Press)
  • FDA panel votes in favor of approving AstraZeneca's gout drug (Reuters) (MedpageToday) (Pink Sheet-$)
  • FDA clears J&J's chemotherapy for certain soft tissue sarcomas (Reuters)
  • Martin Shkreli Won't Suffer Because Of That $1-A-Pill Competitor. Here's Why (Forbes)
  • Bacteriophage Treatment Decontaminates Infant Formula (American Society for Microbiology)

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

  • Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL) (Pfizer)
  • Revive Therapeutics Announces US FDA Grants Orphan Drug Designation for Bucillamine for the Treatment of Cystinuria (Press)
  • Onxeo announces data demonstrating high patient compliance and acceptability of Validive for treatment of severe oral mucositis (MNT)

US: Medical Devices

  • Walgreens Scrutinizes Theranos Testing (WSJ-$)
  • FDA Outlines Discussion Topics for Upcoming Public Workshops on NGS Test Regulation (GenomeWeb)
  • Parallel Review Evolves: FDA Expands from Pilot to Considering Private Payers (MDDI)
  • Will Neuro FDA Approval for Medtronic's TYRX Envelope Lead to More Risk Sharing? (MDDI)

US: Assorted and Government

  • U.S. drug prices should reflect value to patients: expert panel (Reuters)
  • Paying For Precision Medicine: The Coverage Conundrum (SCRIP-$)
  • Rare Disease Advocates Eye Reinstatement Of Orphan Products Board (Pink Sheet-$)
  • Congress Continues Spree of Proposing Alternative Incentives for Product Development: the Qualified Infectious Disease Tax Credit (Part 2) (FDA Law Blog)
  • Viekira Pak Safety Alert Prompts Express Scripts Review Of Exclusive Coverage (Pink Sheet-$)
  • New Senate Bills To Streamline Device Modifications, Expand HDEs Align With House Provisions (Gray Sheet-$)

Upcoming Meetings and Events              


  • Amgen's T-Vec inches toward EU approval for melanoma (FierceBiotech)
  • Janssen Receives Positive CHMP Opinion Recommending EDURANT (Press)
  • CHMP Nod Little Consolation As Amgen's Imlygic Becomes Melanoma Also-Ran (Pink Sheet-$)
  • Animal testing in UK labs falls 6% (PharmaTimes)
  • Novartis’ Cosentyx gets European approval for two conditions (Pharmafile)
  • EFPIA Statement in Response to Criticism of the Adaptive Pathways Project (EFPIA)


  • Maharashtra government begins sale of Ayurvedic medicines, herbal products (Economic Times)
  • Drugmakers plan to get together to discuss how to get out of FDA warnings and bans (Economic Times)
  • India’s Pharma & Medical Devices Marketing Code: Six Questions For The Pharma Dept (24 Insight)
  • Aurobindo gets FDA approval for generic Namenda (DSN)
  • R&D spending of 25 India pharma cos soar by 28.8% in 2014-15 (PharmaBiz)



  • Nemus’ glaucoma drug secures patent in Japan (BioSpectrum)

General Health and Other Interesting Articles

  • MERS, Ebola, bird flu: Science's big missed opportunities (Reuters)
  • Hot dogs, bacon and other processed meats cause cancer, World Health Organization declares (Washington Post)
  • Hospitals Mess Up Medications in Surgery—a Lot (Bloomberg)

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

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

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