Regulatory Focus™ > News Articles > Regulatory Recon: Olympus Raised Scope Prices Following Superbug Outbreak, Gilead to Pay Merck $200m

Regulatory Recon: Olympus Raised Scope Prices Following Superbug Outbreak, Gilead to Pay Merck $200m in Damages Over Hep C Patents (25 March 2016)

Posted 25 March 2016 | By Michael Mezher 

Regulatory Recon: Olympus Raised Scope Prices Following Superbug Outbreak, Gilead to Pay Merck $200m in Damages Over Hep C Patents (25 March 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

  • Using Social Media to Assess Health from Afar (Scientific American)
  • Will Portola's Betrixaban Data Pass Muster With FDA? (Pink Sheet-$) (BioCentury)
  • FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions (Focus) (FDA Law Blog) (STAT)
  • New system in the works to better track faulty medical devices (Baltimore Sun)
  • Device Maker Olympus Hiked Prices For Scopes As Superbug Infections Spread (KHN)
  • Gilead has taken a lot of hits lately. Here's what it really has to fear (STAT)
  • Gilead to Pay Merck $200 Million in Damages Over Hepatitis C Drug Patents (WSJ-$) (Reuters)

In Focus: International

  • Health Canada and FDA Joint Public Consultation on ICH Guideliness (Health Canada)
  • EU Roundup: PRAC Recommends Antibiotics to Offset Zydelig Infection Risks, Update on Medical Literature Monitoring Service (Focus)
  • EU Discussion On Medtech Standards Future To Wait Until Regulations Are Adopted (SCRIP-$)
  • China's Vaccine Scandal Reveals System's Flaws, More than 130 Arrested (WSJ-$) (BBC) (Economic Times) (Time)
  • Summer 2016 Enforcement Date Set for Chinese Medical Device Clinical Trial Rules (Emergo)
  • Sanofi goes to High Court over Indian ban on fixed dose combo diabetes drug (In-PharmaTechnologist)
  • Canada will not appeal ruling allowing patients to grow own pot (Reuters)

US: Pharmaceuticals & Biotechnology

  • Bayer and Regeneron to develop new eye combination therapy (PharmaPhorum)
  • Race to Comply with FDA ESG Guidelines (Focus-Members Only)
  • Researchers Call for Transparency When Black Box Warnings Are Removed (Focus)
  • Consent and Consistency in the NPRM (Harvard Bill of Health)
  • Cancer research 'moonshot' wins enthusiastic support in STAT-Harvard poll (STAT)
  • Many patients with high stroke risk don't get needed blood thinners (Reuters)
  • DUNS vs NDC Number for OTC Drug Registration (FDA Atty)
  • Restructuring Looms for Forum as Neuro Drug Fails Key Clinical Test (Xconomy) (Press)
  • A New Arena For Reducing Antibiotic Misuse: Outpatient Care (Health Affairs Blog)
  • USP Reference Standards: 5 Tools You Should Know About (USP)
  • Thinking Outside The Box On Rx Pricing: From Vaccines To Part D Bundling (RPM Report-$)

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

  • Pivotal Phase III Trial of enzalutamide Initiated in Metastatic Hormone Sensitive Prostate Cancer (Press)

US: Medical Devices

  • Take the Cybersecurity Bullseye Off Your Back (Pharmaceutical Compliance Monitor)
  • An Introduction To Manufacturing Execution Systems For The Medical Device Industry (MedDeviceOnline)
  • Quality Management has Moved On! (GxP Lifeline)
  • Ackman: Pershing Square Gets Senate Inquiry on Drug Prices (Bloomberg)
  • Sanuwave trial misses efficacy endpoint but shows superiority at 24 weeks (MassDevice)
  • Xeltis Bioabsorbable Cardiac Pulmonary Valve for Congenital Outflow Tract Obstructions Green Lit by FDA (medGadget)
  • Fortimedix Surgical Announces 510(k) Submission for Innovative FMX314 Surgical Platform (Press)
  • TransEnterix, Inc. Provides Update on SurgiBot FDA 510(k) Submission Process (Press)
  • Carestream seeks FDA nod for OnSight 3D cone-beam extremities CT imager (MassDevice)

US: Assorted & Government

  • Genzyme Hits Sun With Suit Over Generic Leukemia Drug (Law360-$)
  • Indivior Says FDA Petition Didn't Delay Generic Suboxone (Law360-$)
  • Sequenom Throws Diagnostic Method Patents At Mercy Of Supreme Court (National Law Review)
  • Last of Five Defendants Pleads Guilty in Multimillion-Dollar Medicare Fraud Scheme involving Detroit-Area Home Health Companies (DoJ)
  • The Zubik v. Burwell Oral Argument (Harvard Bill of Health)
  • Do Payers Pay More If Drug Risks Are Not Disclosed? GSK Seeks Supreme Court Answer (Pink Sheet-$)
  • Fed. Circ. Upholds Validity Of Depomed Drug Patents (Law360-$)
  • U.S. regulators finalize new silica limits for construction, other industries (Reuters)

Upcoming Meetings & Events

  • RAPS' FDA Advisory Committee Meeting Tracker
  • Background Analysis: US FDA Advisory Committees to Review Teva's Proposed Extended-Release Opioid with Abuse-Deterrent Properties – JUN 7, 2016 (AADPAC-DSRM) (Tarius)
  • Background Analysis: US FDA Advisory Committee to Review Novo Nordisk's Insulin Degludec and Liraglutide (Xultophy) for Type 2 Diabetes – MAY 24, 2016 (EMDAC) (Tarius)

Europe

  • Harmonization Key To Future EU GCP Inspections, Says Industry (SCRIP-$)
  • With Andrew Witty's Departure, Will GlaxoSmithKline Say Goodbye to Fraud? (Forbes)
  • Poland to ban prescription-free emergency contraception (Reuters)
  • EC approves marketing authorization switch of Elocta from Biogen to SOBI (PharmaLetter-$)

Asia

  • China FDA vows to fix vaccine supply "gaps" in remarks at Boao Forum (Fierce)
  • Lilly Japan Looks To New Launches As Zyprexa Challenge Looms (PharmAsiaNews-$)

India

  • India Won't Cease Controversial Drug-Licensing Policy (Law360-$)
  • NPPA to settle disputes with drug makers for over-charging medicines (Economic Times)

Canada

  • LumiThera wins Health Canada nod for photobiomodulation trial (MassDevice)

Zika

  • One Traveler May Have Brought Zika to the Americas in 2013 (NYTimes) (Reuters)

General Health & Other Interesting Articles

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.


Categories: Recon, Regulatory News

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