Regulatory Recon: China Rejects Gilead Patent on Sovaldi Prodrug (19 June 2015)

Posted 19 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

  • What Happened at the GDUFA II Meeting and What is Happening at OGD? (Lachman)
  • Novartis, Momenta free to launch Copaxone generic (PharmaTimes) (NYTimes) (Court Case) (Reuters)
  • Vaccines for mothers: FDA talks stumbling blocks on new pathway (BioPharma Reporter)
  • FDA Advisory Committee Reviews Pharmacy Compounding Drug Lists (Tarius)
  • FDA cracks down on over 1,000 illegal online medicine sellers (Reuters) (FDA)
  • FDA allows marketing of new device to help the blind process visual signals via their tongues (FDA) (WaPo)
  • FDA Device Guidances in "Transparency" Spotlight (MDDI)

In Focus: International

  • China rejects patent linked to Gilead hepatitis C drug (Reuters)
  • China FDA exempts 'equivalent' devices from clinical trials (PharmPro)
  • NICE wants more answers from Gilead on Zydelig (Pharmafile) (PharmaTimes)
  • NICE turns down Celgene's Otezla for psoriatic arthritis (PharmaTimes)
  • Council on EU IVD reg: good news on 5-year grace and scrutiny, but industry wants "serious discussions" (Clinica-$)
  • Central drug controller unveils 'world's biggest' quality check (Indian Express)
  • Prescription for Arrest: Japan's Drug Laws Snare Foreigners (Bloomberg)
  • Clinical trials in early 2015 down compared to previous year (PharmPro)

US: Pharmaceuticals and Biotechnology

  • What Happened at the GDUFA II Meeting and What is Happening at OGD? (Lachman)
  • Novartis, Momenta free to launch Copaxone generic (PharmaTimes) (NYTimes) (Court Case) (Reuters)
  • Vaccines for mothers: FDA talks stumbling blocks on new pathway (BioPharma Reporter)
  • FDA Advisory Committee Reviews Pharmacy Compounding Drug Lists (Tarius)
  • FDA cracks down on over 1,000 illegal online medicine sellers (Reuters) (FDA)
  • FDA to study concerns regarding spray-on sunscreens (KVUE)
  • PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up (Pink Sheet-$)
  • Intra-Department Grudge Match – FDA vs. NIH? (FDA Law Blog)

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

  • Amgen's Vectibix boosts survival in colorectal cancer patients (PharmaTimes) (Reuters)
  • Tekmira's Ebola Treatment Falls Short in Trial (Press)
  • Upstart Aimmune bags a 'breakthrough' tag for its peanut allergy drug (Fierce) (Press) (BioCentury) (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA allows marketing of new device to help the blind process visual signals via their tongues (FDA) (WaPo)
  • FDA moves to decide on Cerapedic's bone graft PMA faster than anticipated (Fierce)
  • FDA issues safety warning to cardiologists based on troubling post-market data (Fierce)

US: Dietary Supplements

  • McCaskill Not Sold On Retailer Exemption From Supplement AER Filing (Tan Sheet-$)

US: Assorted And Government

  • FDA Device Guidances in "Transparency" Spotlight (MDDI)
  • 251 Patient Groups Come out in Support of 21st Century Cures Act (E&C)
  • House Votes to Repeal Medical Device Tax (MDDI)

Upcoming Meetings and Events

Europe

  • NICE wants more answers from Gilead on Zydelig (Pharmafile) (PharmaTimes)
  • NICE turns down Celgene's Otezla for psoriatic arthritis (PharmaTimes)
  • Council on EU IVD reg: good news on 5-year grace and scrutiny, but industry wants "serious discussions" (Clinica-$)
  • Concept paper on the testing strategy and risk assessment for plants in the Phase II of the environmental risk assessment for veterinary medicinal products (EMA)
  • ALung Receives CE Mark for New Hemolung XG4 Cartridge and Catheter Kits (Press)

India

  • Central drug controller unveils 'world's biggest' quality check (Indian Express)
  • DCGI appoints FICCI as nodal agency for consolidating guidelines on e-commerce (PharmaBiz)
  • IPC launches android mobile application for ADR reporting facilities (PharmaBiz)
  • Indian Pharma's Role in Global Drug Supply (USP)

China

  • China rejects patent linked to Gilead hepatitis C drug (Reuters)
  • China FDA exempts 'equivalent' devices from clinical trials (PharmPro)
  • Chinese officials used prostate problems to get 'confession', says ex-GSK sleuth (Guardian)

Japan

  • Prescription for Arrest: Japan's Drug Laws Snare Foreigners (Bloomberg)

Canada

  • Medical Device Licensing and Approval in Canada (MassDevice)

Australia

  • Biosimilar medicines: New class of generic biological drugs to be introduced as cheaper option (ABC)

Clinical Trials

  • Clinical trials in early 2015 down compared to previous year (PharmPro)
  • Head-to-head clinical trials "almost always" back industry sponsor (AllTrials)
  • Expect More Trials with mHealth Data (MDDI)

Other International

  • ANVISA extends deadline for technical requirement responses in Brazil (MassDevice)

General Regulatory And Interesting Articles

  • NIH Researchers design placenta-on-a-chip to study pregnancy (MassDevice) (MNT) (WaPo)

Regulatory Reconnaissance #579 – 19 June 2015

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.

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