Regulatory Recon: Texas Sues FDA Over Death Penalty Drugs; Head of FDA's Criminal Office Departs (4 January 2017)

Posted 04 January 2017 By Michael Mezher

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

In Focus: US

  • Biotech Deals Will Bounce Back in 2017 (Bloomberg)
  • Chief of FDA's criminal office to depart as Trump takes office (Reuters)
  • Texas Sues FDA Over Death Penalty Drug Import Delay (Law360-$) (Pharmafile) (BuzzFeed)
  • Gilead poaches Novartis cancer specialist Riva (Reuters) (Fierce) (Endpoints)
  • Former Novartis Pharma-Unit Head Joins Venture-Capital Firm (WSJ)
  • ORI misconduct findings fell in 2016. Why? We ask the director (Retraction Watch)
  • Will California's New 'Right to Try' Law Empower or Exploit Patients? (KQED)
  • US Republican Senator Introduces Obamacare Repeal Resolution (Reuters)
  • A Bipartisan Reason to Save Obamacare (NYTimes)
  • The Parliamentary Tactic That Could Obliterate Obamacare (NYTimes)
  • On Jan. 3, The Republican Congress Readies Its Assault On Medicare And Medicaid (Forbes) (IHP-$)
  • US FDA Has Slim Advisory Committee Schedule – A Sign Of Things Not To Come? (Pink Sheet-$)
  • As opioid epidemic worsens, the cost of waking up from an overdose soars (CNBC)
  • Allergan took its pricing pledge last fall about as literally as it gets (MarketWatch) (The Street)
  • The Problems With 'Repeal And Delay' (Health Affairs Blog)
  • RNA-Drug Startup RaNA Enters A Race With A Unicorn (Forbes)
  • Judge halves $1 billion award in J&J hip implants case (Reuters) (MassDevice)
  • Sanofi, Regeneron lose bid to overturn Amgen win in patent case (Reuters) (Pharmafile)
  • FDA Finalizes Postmarket Cybersecurity Guidance (Focus)
  • Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance (Focus)
  • FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations  (Focus)
  • FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars (Focus)
  • CDRH Speeds Release of Device Recall Information (Focus)
  • What Is the Purpose of the Orphan Drug Act? (PLOS)
  • Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage (PLOS)

In Focus: International

  • China jails former drug regulatory official for taking bribes: state media (Reuters)
  • Cost of pharma M&A deals doubles since 2015 (Financial Times)
  • Greek authorities raid Novartis' offices after bribery allegations (Pharmafile) (Reuters)
  • Bayer's Zieler On The Power Of Real World Data, Asia Pacific Outlook (SCRIP-$)
  • NICE backs Amicus' Galafold for Fabry disease (PharmaTimes)
  • Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (Focus)
  • $100M cash boost for Ascletis as Chinese hep C race gathers pace (Fierce)
  • How Are Regulatory Changes Affecting Early-Stage R&D In China? (Pink Sheet-$)
  • Priority-Setting for Novel Drug Regimens to Treat Tuberculosis: An Epidemiologic Model (PLOS)
  • Japanese companies make cautious return to Indian pharma market (Economic Times)
  • EU Medical Devices Regulation Series: Interpreting the "Industrial Scale" Concept (National Law Review)
  • Fire at Sun Pharma API factory kills two (InPharmaTechnologist) (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Braeburn Pharmaceuticals files plans for $150m IPO (Drug Delivery)
  • Two-Thirds of Drugs Approved in 2016 Granted Priority Review (FDANews-$)
  • Ono Pharma's Wild 2016 Ride Cuts Stock Valuation by $16 Billion (Bloomberg)
  • Biosimilars Ineligible For Reduced Medicaid Rebates As Authorized Generics (Pink Sheet-$)
  • FDA Announces Implementation of GFI #213, Outlines Continuing Efforts to Address Antimicrobial Resistance (FDA)
  • FDA Conditionally Approves Tanovea-CA1, the first New Animal Drug for Treating Lymphoma in Dogs (FDA)
  • Versant closes $400M life sciences fund as it hits 2017 running (Fierce)
  • In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Draft Guidance for Industry; Availability (FDA)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion (FDA)

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

  • FDA Grants Bayer Priority Review for Stivarga® (regorafenib) for the Second-Line Systemic Treatment of Liver Cancer (Press)
  • Protalix talks up CF prospects in interim phase 2 data drop (Fierce)
  • Sanofi Announces Soliqua™ 100/33 now Available in the U.S. (Press)
  • Ganaxolone Designated Orphan Drug for Fragile X Syndrome (MPR)
  • Newron announces encouraging preliminary results of its Phase IIa study with Evenamide in patients with schizophrenia (Press)
  • Cidara Therapeutics Completes Enrollment in Phase 2 RADIANT Trial Evaluating Novel Antifungal CD101 Topical in Vulvovaginal Candidiasis (Press)
  • Tarveda Therapeutics Announces Phase 1/2a Clinical Trial of PEN-221 Underway in Patients with Neuroendocrine Tumors and Small Cell Lung Cancer (Press)
  • Cellectis Submits IND Application for UCART123, an Allogeneic Gene Edited CAR T-Cell Product Candidate, in AML and BPDCN (Press)
  • FDA Grants Fast Track Designation to Enanta's FXR Agonist Candidate, EDP-305, for the treatment of NASH with Liver Fibrosis (Press)
  • FDA Accepts For Filing Supplemental New Drug Application (sNDA) For LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg (Press)
  • CytRx Granted Type B Pre-NDA Meeting with U.S. FDA for Registration Pathway with Aldoxorubicin as a Treatment for Patients with Relapsed Soft Tissue Sarcomas (Press)
  • Senhwa Biosciences CX-4945 Granted Orphan Drug Designation by the US FDA in Cholangiocarcinoma (Press)

US: Medical Devices

  • CES 2017: Medical technologies you should check out (MassDevice)
  • Analyst: There's a 'mismatch' between expectations and reality for Stryker's Mako platform (MassDevice)
  • Class 1 Device Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections (FDA)
  • Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, Renewal (FDA)

US: Assorted & Government

  • Where Equivalence Isn't Equivalent: Using 510(k)s in Patent Litigation (MDDI)
  • Senate Committee Closes Books On 2016 Pricing Investigation; PBMs In Hot Seat Next? (Pink Sheet-$)
  • Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop; Establishment of a Public Docket; Request for Comments (FDA)
  • Why Health Insurers Worry About Trump's HHS Pick, Tom Price (Forbes)
  • GSK Vaccine Sales Exempt From Antitrust Law, 9th Circ. Says (Law360-$)
  • SDNY Applies Preemption in Favor of Branded Drug (Drug and Device Law)
  • In Time for the Holidays, FDA Grants PCPC's Petition for Lead Levels in Lipstick and Externally Applied Cosmetics (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • #FakeMeds in 2017: New Year, Same Danger (MHRA)
  • Mundipharma bags rights to Vectura's novel respiratory therapy (PharmaTimes)
  • Millions of UK asthma patients not receiving basic care (PharmaTimes)
  • Record Fine For Pfizer Throws Spotlight On UK Generic Pricing (Pink Sheet-$)
  • France to suspend sales of Uvesterol D Vitamin D deficiency product (Reuters)
  • European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting (EMA)
  • VolitionRx Gets CE Mark for Colorectal Cancer Screening Test (GenomeWeb)

Asia

  • Lucky Rooster? A Stellar Year Ahead For Chinese Pharma Investment (SCRIP-$)

India

  • Battle for access to tuberculosis medicine reaches HC (Economic Times)
  • CDSCO Issues Notice on Import of Radiopharmaceuticals (CDSCO)
  • The cuts that complicate efforts to cap stent price (Economic Times)
  • Indian companies grab 34% of total US FDA approvals during 2016 (PharmaBiz)
  • Gujarat FDCA to cancel licenses of 2 stockists for running inter-state spurious drug racket (PharmaBiz)

Canada

  • Notice – Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format (Health Canada)

Australia

  • Implementation of updates to ISO 14644 Parts 1 & 2 (2015) (TGA)

Zika

  • Zika Virus Infection as a Cause of Congenital Brain Abnormalities and Guillain–Barré Syndrome: Systematic Review (PLOS)
  • Globally Zika Virus vaccines market expected to reach $18,697mn by 2022 (BioSpectrum)

Other International

  • BioTime and subsidiary establish cell manufacturing facility in Israel (Drug Delivery)

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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