Regulatory Focus™ > News Articles > Regulatory Recon: What you Need to Know About China's New Biosimilar Process (11 November 2014)

Regulatory Recon: What you Need to Know About China's New Biosimilar Process (11 November 2014)

Posted 11 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: What you Need to Know About China's New Biosimilar Process (11 November 2014)

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

In Focus: US

  • Justice Department Probes Generic Competition After Price Hike Reports (Pharmalot)
  • Plaintiffs Renew Bid to See Diabetes Drug Adverse Event Reports (Law)
  • Do Depression Drugs Still Need Suicide Warnings? (TIME)
  • Court approves $325 million settlement against Pfizer (Boston herald)
  • Medical Device Cybersecurity: Five Questions the Industry Needs to Ask Now (MDDI)
  • Medical Device Makers Challenged by FDA Mandates for UDI (EMDT)
  • Companion Diagnostics: Why Medical Device Manufacturers Should Care (MedDeviceOnline)
  • "Sunshine" Database Picks Up Most Vetted-of-Vetted Doctors: FDA Advisory Committee Members (RPM Report-$)
  • How the Republican wave resets expectations for revamping FDA (BioCentury-$)

In Focus: International

  • China launches its biosimilars process (BioCentury) (Translated Regulation)
  • Countdown to Japan’s new medtech law: what changes to look out for (Clinica-$) (Law 360-$)
  • Japan unveils sunshine data of its own, raising eyebrows after Diovan scandal (Fierce) (Pharmalot)
  • New tool for companies to facilitate maintenance of information on authorised medicines (EMA)
  • Five new drugs for NHS Scotland (PharmaTimes)
  • India gets minister for traditional medicine (Reuters)
  • Medical Experts Look For New Ways To Test Ebola Drugs (NPR)
  • Ebola Contracts Worth $2 Billion Could Benefit Drugmakers (Bloomberg)

US: Pharmaceuticals and Biotechnology

  • Justice Department Probes Generic Competition After Price Hike Reports (Pharmalot)
  • Plaintiffs Renew Bid to See Diabetes Drug Adverse Event Reports (Law)
  • Do Depression Drugs Still Need Suicide Warnings? (TIME)
  • How pharmacology may be driving FDA decision on Daiichi’s new anticoagulant (BioCentury-$)
  • US FDA Advisory Committee to Discuss Clinical Trial Development for Antibacterial Products (Tarius)
  • FDA Aspergillosis Biomarker Qualification Highlights New Drug Development Tool Process (RPM Report-$)
  • Team-Based Quality Assessment Approach Among Key Changes Underway as CDER’s Office of Pharmaceutical Quality Comes to Life (IPQ-$)
  • Vancomycin Shortage Listing Raises Question On FDA’s Prevention Strategy (Pink Sheet-$)
  • Court approves $325 million settlement against Pfizer (Boston herald)
  • NYT: Pfizer lobbied Missouri AG to win favorable off-label deal (Fierce)
  • Entyvio REMS Decision Explained (RPM Report-$)
  • Drug Cos. Seek Judgment In Nexium Pay-For-Delay Case (Law 360-$)
  • Del. Court Is 1st To Apply Daimler To Hatch-Waxman Case (Law 360-$)

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

  • Amgen takes another stride in frenzied race toward the PCSK9 finish line (Fierce) (SCRIP-$)
  • Sanofi/Regeneron's dupilumab shines in asthma trial (PharmaTimes) (SCRIP-$) (Reuters) (Fierce)
  • Navidea Receives $1.1Million PDUFA Filing Fee Refund for Award of Orphan Drug Status (Press)
  • Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment (Press)
  • Synageva BioPharma Presents New Data From Phase 3 Study Of Sebelipase Alfa In Children And Adults With LAL Deficiency At The AASLD Meeting (Press)
  • Threshold Pharmaceuticals Receives FDA Fast Track Designation for TH-302 for the Treatment of Previously Untreated Patients With Metastatic or Locally Advanced Unresectable Soft Tissue Sarcoma (Press)
  • Battered ArQule shares bump up on badly needed positive data for tivantinib (Fierce)
  • Pradaxa antidote enters Phase III (MM&M)
  • ACADIA Pharmaceuticals Updates Timing of NUPLAZID NDA Submission (Press)

US: Pharmaceuticals and Biotechnology: General

  • How NORD is putting patients in control of rare disease natural history studies (BioCentury-$)

US: Medical Devices

  • Medical Device Cybersecurity: Five Questions the Industry Needs to Ask Now (MDDI)
  • Medical Device Makers Challenged by FDA Mandates for UDI (EMDT)
  • Companion Diagnostics: Why Medical Device Manufacturers Should Care (MedDeviceOnline)
  • Qiagen set to benefit from increased test regulation by the FDA (EP Vantage)
  • Former FDA Official Quynh T. Hoang Joins King & Spalding in Washington, D.C. (Press)
  • Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems (FDA)
  • FDA Clears World’s First Patient-Specific Spinal Rod (Press)
  • West Receives 510(k) Clearance for NovaGuard SA Safety System (Press)
  • Titan Spine Receives FDA Approval for Next Generation nanoLOCK Surface Technology (Press)
  • Device for minimally invasive treatment of enlarged prostate gains CMS reimbursement (Fierce)

US: Dietary Supplements

  • Judge Orders Mediation in Bayer/FTC Litigation, Private Plaintiffs Want Documents (NPI)
  • Fabricant Defends Regulation of Dietary Supplements (NPI)

US: Assorted And Government

  • How the Republican wave resets expectations for revamping FDA (BioCentury-$)
  • "Sunshine" Database Picks Up Most Vetted-of-Vetted Doctors: FDA Advisory Committee Members (RPM Report-$)
  • FDA Posts a Weird, Weird Debarrment (FDA) (Lachman)
  • CMS Sunshine Data And Ultra-Orphan Relationships: Aegerion May Have More Payments Than Patients (RPM Report-$)
  • House Dems urge leaders to increase NIH funding (The Hill)

Upcoming Meetings

Ebola Outbreak

  • Medical Experts Look For New Ways To Test Ebola Drugs (NPR)
  • Ebola Contracts Worth $2 Billion Could Benefit Drugmakers (Bloomberg)
  • GSK ‘moves best people’ to keep Ebola vaccine manufacture in-house (Outsourcing Pharma)
  • Fujifilm says tests results on Avigan as Ebola drug by end-2014 (Reuters)

Europe

  • New tool for companies to facilitate maintenance of information on authorised medicines (EMA)
  • Five new drugs for NHS Scotland (PharmaTimes)
  • SMC Rejects Perjeta (Herald Scotland)
  • Orexigen Rises as Weight Loss Drug Review Proceeds (AP) (BioCentury)

India

  • India gets minister for traditional medicine (Reuters)

China

Japan

  • Countdown to Japan’s new medtech law: what changes to look out for (Clinica-$) (Law 360-$)
  • Japan unveils sunshine data of its own, raising eyebrows after Diovan scandal (Fierce) (Pharmalot)
  • Medtronic wins nod in Japan for Evera MRI-safe ICD (Mass Device)

Canada

  • Octapharma's Nuwiq gets Health Canada approval to treat hemophilia A (PBR)

Australia

  • Consultations on adoption of European Union guidelines in Australia: Outcome of previous consultation (TGA)
  • All EMA Standards Adopted by TGA (TGA)

Other International

  • 5 years on from the Brazilian Generics Drugs Act, is there still an opportunity for branded originator drugs? (EyeforPharma)

Clinical Trials

  • Check Up: Cardiac clinical trials short on diversity in age, race, gender (Inquirer)
  • Clinical trials insight: cardiovascular disease (PharmaPhorum)

General Regulatory And Interesting Articles

  • Here’s How You Milk Snakes to Make Antivenom (Wired)
  • Device Changes Your Mood with a Zap to the Head (MIT Tech Review)

Regulatory Reconnaissance #438 – 11 November 2014

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 @AlecGaffney 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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