Regulatory Recon: Colombia Cuts Price of Novartis' Gleevec by 44 Percent; FDA Extends Review of Roche MS Drug Ocrevus Over New Manufacturing Data (21 December 2016)

Posted 21 December 2016 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • FDA: No Fingerstick Needed with Dexcom G5 CGM (Medpage) (Press) (FDA)
  • FDA Extends Review of Roche MS Drug Ocrevus by Three Months (Pink Sheet-$) (Reuters)  (Fierce) (Press)
  • FDA Director's Corner Podcast – Addressing the Opioid Epidemic (FDA)
  • One-on-one with Trump's doctor (STAT)
  • Desperately Seeking A New FDA Commissioner, A Critical Presidential Appointment (Forbes)
  • Merrimack ends breast cancer drug study over likely futility (Reuters)
  • Inovio Zika vaccine evokes robust response in early human study (Reuters)
  • What Will Tom Price Do as HHS Secretary? (Medpage)
  • Senate Democrats to Trump: Work With us to Lower Drug Prices (Focus) (Politico) (ICER)
  • Senate Aims to Stop Firms From 'Buying Up Drugs and Jacking Up Prices' (NYTimes)
  • Trump Is Going After Health Care. Will Democrats Push Back? (NYTimes)
  • FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions (Focus)
  • FDA Officials Call for Including Adolescents in Adult Oncology Trials (Focus)
  • 2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning (Focus)
  • Biogen Approves Spin-out of Hemophilia Business (The Street) (PharmaLetter-$) (WSJ)
  • Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations (Pink Sheet-$)
  • Why the 21st Century Cures Act Is Great News For Healthcare (The Health Care Blog)
  • Why Do People Believe Drugs Are Too Expensive? (Policy and Medicine)
  • Hospitals And Surgery Centers Play Tug-Of-War Over America's Ailing Knees (KHN) (NYTimes)
  • Cancer-Free: One Recovery Inspires Another — and Could Help Thousands (NYTimes)
  • Are new anti-cancer drugs worth the cost? (Healthcare Economist)

In Focus: International

  • Colombia cuts price of Novartis cancer drug by 44 percent (Reuters)
  • GlaxoSmithKline's New Drug Challenges HIV Treatment Orthodoxy (WSJ)
  • World Health Organization rethinks its response to disease outbreaks (Nature)
  • Novartis seals two deals to bolster drug pipeline (Pharmafile) (EP Vantage)
  • CFDA proposes updates to clinical practices (BioCentury)
  • OxyContin goes global — "We're only just getting started" (LA Times)
  • Drug Makers Urged To Collect Own Excipient Metals Data To Comply With ICH Q3D (Pink Sheet-$)
  • Incyte in $200M-plus Merus research deal, shares jump (Fierce)
  • Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations (Focus)
  • Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (Focus)
  • News from Abroad: Antibodies in the European Patent Office (Patent Docs)
  • Revision of biosimilar guidelines by CDSCO in line with global norms to boost biosimilars access (PharmaBiz)
  • First Biosimilar MabThera One Step Away from EU Approval; Pegfilgrastim Filings Withdrawn (Pink Sheet-$)
  • Astellas Completes Acquisition of Ganymed Pharmaceuticals (Press)
  • IPEC Leaders Tout Benefits of Documented Risk Assessments Called for in EXCiPACT and NSF/IPEC/ANSI 363 GMP Standards (IPQ)
  • European Parliament demands Berlin compensate victims of killer drug (EurActiv)

US: Pharmaceuticals & Biotechnology

  • Impax CEO Wilkinson out as company searches for new leadership (Fierce)
  • Pharmaceutical Formulations: Ready For Patenting? (Law360-$)
  • After trial disaster, BioInvent bounces back with Pfizer deal (Fierce)
  • IL-7 Receptor Mutations and Steroid Resistance in Pediatric T cell Acute Lymphoblastic Leukemia: A Genome Sequencing Study (PLOS)
  • Overcoming Steroid Resistance in T Cell Acute Lymphoblastic Leukemia (PLOS)
  • Exploratory Analysis of TP53 Mutations in Circulating Tumour DNA as Biomarkers of Treatment Response for Patients with Relapsed High-Grade Serous Ovarian Carcinoma: A Retrospective Study (PLOS)
  • Fentanyl Contributes To Record Drug Overdoses In New York City (NPR)
  • Jubilant recalls 1.5k bottles of methylprednisolone tabs in US (Economic Times)
  • Aging And Addicted: The Opioid Epidemic Affects Older Adults, Too (KHN)
  • More Bad News In Our Nation's Fight Against Alzheimer's Disease (Forbes)
  • In Battle Against Ovarian Cancer, A New Focus on Fallopian Tubes (KHN)
  • Packaging design: how to ensure successful patient outcomes (OutsourcingPharma)
  • Shire's Ornskov: The Modest Pediatrician With Fierce Corporate Ambition (Scrip-$)
  • 'Site-less CRO' model looks to evolve clinical trials (OutsourcingPharma)
  • New research reverses HIV-related immune suppression (Pharmafile)

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

  • Tesaro bags priority review, June PDUFA for PARP inhibitor (Fierce)
  • AbbVie, Galapagos' Kalydeco challenger clears phase 2 (Fierce)
  • FDA Accepts Supplemental New Drug Application for Pfizer's IBRANCE® (palbociclib) in HR+, HER2- Metastatic Breast Cancer (Press)
  • Elusys Therapeutics Announces Publication Of Data Establishing The Adult Human Dose For Its Inhalational Anthrax Antitoxin, ANTHIM® (obiltoxaximab) Injection (Press)
  • Concert Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating CTP-656 for the Treatment of Cystic Fibrosis (Press)
  • Bristol-Myers Squibb and Calithera Biosciences Announce Clinical Collaboration to Evaluate Opdivo (nivolumab) in Combination with CB-839 in Clear Cell Renal Cell Carcinoma (Press)

US: Medical Devices

  • Top Medtech News Stories of 2016 (MDDI)
  • How the New FDA Guidance on Biocompatibility Affects Medical Device Manufacturers (MDDI)
  • Changing your medical device: What you need to know (MassDevice)

US: Assorted & Government

  • Teva Accuses Mylan, Others Of Infringing Copaxone Patent (Law360-$)
  • Good Things Come in Small Packages: M.D. Fla. Rejects Plaintiff's Discovery Gotcha Gamesmanship (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • European Medicines Agency closed 23 December 2016 to 2 January 2017 (EMA)
  • Extended EU treatment access for metformin products (PharmaLetter-$)
  • The Importance of Pharmacovigilance: Guest comment from Dr Colin Cable (ABPI)
  • Simpler website navigation for regulatory information on veterinary medicines (EMA)

India

  • CDSCO Adds Sub-Accounts to SUGAM Portal (CDSCO)
  • Price collusion charges of US DoJ may impact Indian pharma cos adversely: ICRA (PharmaBiz)
  • Sun Pharma completes acquisition of 85% stake in JSC Biosintez (Economic Times)

Australia

  • Medicines Safety Update Volume 7 Number 5, October-December 2016 (TGA)
  • TGA presentation: ARCS Webinar, 13 December 2016 (TGA)
  • ACSOV meeting statement, Meeting 13, 9 December 2016 (TGA)
  • Combined hormonal contraceptives: Safety advisory - updated information about risk of blood clots (TGA)

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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