Regulatory Recon: GPhA Urges Senate to Stop Generic Delays, Perspectives on Data Sharing (6 January 2016)

Posted 06 January 2016 | By Michael Mezher 

Regulatory Recon: GPhA Urges Senate to Stop Generic Delays, Perspectives on Data Sharing (6 January 2016)

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

  • Gilead's Hep B drug as Effective as Viread But Safer (Reuters)
  • Generic-Drug Cos. Urge Senate To Fight FDA Approval Delays (Law360-$) (GPhA Statement)
  • Washington has big hopes, but little power, to negotiate drug prices (STAT)
  • MannKind, Sanofi End Licensing Pact for Diabetes Medicine Afrezza (WSJ-$) (Reuters)
  • Actelion sees Uptravi price of $160,000-170,000/patient (Reuters)

In Focus: International

  • India Announces Exemptions, Relaxation of Track and Trace for Pharma Exports (24 Insight) (Economic Times)
  • How to Stop Crypto, a Deadly Disease So Neglected it's Missed on the 'Neglected' List (Newsweek)
  • Status Report: Health Canada, CMDCAS, US FDA and the MDSAP (Emergo)
  • Developing Global Norms for Sharing Data and Results during Public Health Emergencies (PLoS)
  • Data Sharing as Part of the Normal Scientific Process: A View from the Pharmaceutical Industry (PLoS)

US: Pharmaceuticals and Biotechnology

  • FDA's Ongoing User Fee System Upgrade Limits Payment Options (Pink Sheet-$)
  • New Weapons in the Fight Against Multiple Myeloma (WSJ-$)
  • IND Safety Analysis Requires Broader Unblinding Of Reports, FDA Advises (Pink Sheet-$)
  • Real world study demonstrates effectiveness of biosimilar infliximab (EPR)
  • Precision Medicine, Stuck In Second Grade, Flunks Test Of Clinical Utility (CardioBrief)
  • Biologic makers looking to delivery devices to gain competitive edge, Bespak (BioPharma-Reporter)
  • Improving access to clinical trials when biopsies are required (MNT)
  • Eli Lilly's diabetes pill takes market share from J&J, Astra (Reuters)
  • Researchers Warn Against Use of Oral Antifungal Medication During Pregnancy (ICT)
  • High-dose vitamin D supplementation has beneficial immune effects in MS (Pharmaceutical Journal-$)
  • Study identifies medical specialties receiving highest payments from manufacturers (MNT)
  • Hospira Issues a Voluntary Nationwide Recall of One Lot of Magnesium Sulfate in Water for Injection Due to Incorrect Barcode Labeling on the Primary Container (FDA)

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

  • FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis (Press)
  • ChemoCentryx rare-disease drug as effective as standard of care (Reuters)
  • Gilead Terminates Phase 2 Study of Simtuzumab in Patients With Idiopathic Pulmonary Fibrosis (Press)
  • Conatus liver drug shows promise in mid-stage trial (Reuters)
  • More PhIII Success For Acacia's Dopamine Antagonist In PONV (SCRIP-$)
  • Transgene Announces First Patient Randomized in Multinational Phase 3 Trial for Pexa-Vec Oncolytic Immunotherapy in Advanced Liver Cancer (Press)
  • Embera NeuroTherapeutics Announces Successful Completion of Phase 1 Clinical Trial Testing EMB-001, a Potential Novel Treatment for Addictions (Press)
  • Kamada Reports Further Positive Interim Data from Phase 1/2 Study of its Alpha-1 Antitrypsin to Treat Graft Versus Host Disease (Press)
  • Vtesse, Inc. Announces FDA's Granting of Breakthrough Therapy Designation for VTS-270 in Niemann-Pick Type C1 Disease (Press)
  • Vyome Biosciences Announces FDA Acceptance of Investigational New Drug Application in the US for its Lead product VB-1953 to Treat Moderate-to-Severe Acne (Press)

US: Medical Devices

  • Theranos director: Blood tester will be vindicated (CNBC)
  • Medtech approvals of the strange kind (EP Vantage)
  • FDA Plans February Panel Meeting On Surgical Mesh Instruments (Gray Sheet-$)
  • FDA Warns Against Use Of Customed Surgical Kits (Gray Sheet-$)
  • Torax wins FDA HDE clearance for Fenix incontinence system (Mass Device)
  • Valencell Sues Apple, Fitbit, Claims Wearable Sensor Tech Infringed (Xconomy)
  • FDA Reclassifies Intravaginal Culture System Into Class II (FDA)
  • Class I Recall: Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly (FDA)
  • Novocure Files Premarket Approval Supplement Application With FDA for Second Generation Optune System (Press)

US: Assorted and Government

  • HHS drafting prescription drug pricing report (BioCentury)
  • Apotex Decries Biosimilar Notice Ruling At Fed. Circ. (Law360-$)
  • Lawmaker Asks FDA To Launch Criminal Inquiry Into Power Morcellators (Gray Sheet-$)
  • DOJ forces Texas pharmacy to stop mixing drugs until inspection (CBS)
  • Cannabidiol Research and Mailing Marijuana Ads: Several Recent Developments (FDA Law Blog)
  • D.Mass. Invokes Public Disclosure Bar, Demands Specificity, and Refuses to Second-Guess FDA in Dismissing Axium/Onyx Qui Tam Case (Drug and Device Law)
  • HHS Opens Comment Period for Anti-Kickback "Safe Harbor" Provisions (Policy and Medicine)

Upcoming Meetings and Events              


  • Single-use perfusion tech will cut cost of vaccine production, says Univercells (BioPharma-Reporter)


  • Glenmark gets tentative FDA nod for Sanofi's generic Multaq (Economic Times)
  • US FDA points to loose quality controls, data deletions at Zydus Cadila's two facilities (Economic Times) (STAT)
  • IPC, IMA to expand their collaboration to strengthen PvPI (PharmaBiz)


  •  Australia Invites Sponsors To Test Faster, Easier Drug Registration Procedure (SCRIP-$)

Other International

  • Why Medtech Firms Need to Focus on Asia-Pacifc (MDDI)
  • Brazil cuts vaccine doses as health system under pressure (Reuters)
  • Randomized trial in Kenya demonstrates importance of cotrimoxazole prophylaxis for HIV/AIDS management in malaria-endemic regions (MNT) (PLoS)
  • Brazil Grapples With Spread of Zika Virus and Dengue Fever (WSJ-$)

General Health and Other Interesting Articles

  • Human-Animal Chimeras Are Gestating on U.S. Research Farms (MIT Technology Review)
  • Study Shows High Frequency of Spontaneous Mutation in Ebola Virus (ICT)
  • For working-age cancer survivors, debt and bankruptcy are common (Reuters)

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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