Regulatory Focus™ > News Articles > Regulatory Recon: FDA Revokes Ranbaxy's Tentative Approval for Generic Nexium (6 November 2014)

Regulatory Recon: FDA Revokes Ranbaxy's Tentative Approval for Generic Nexium (6 November 2014)

Posted 06 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Revokes Ranbaxy's Tentative Approval for Generic Nexium (6 November 2014)

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

In Focus: US

In Focus: International

  • EU scheme commits $350 million for research on Ebola vaccines, tests (Reuters) (EFPIA)
  • China Solicits Comments on Biosimilars Guideline (JDsupra)
  • MHRA vaginal mesh implants report: benefits of use outweigh risks (MHRA)
  • Fresh look at plasticizers in devices: new EU opinion out for comment (Clinica-$)
  • India: Developing Biosimilars In India: Prescriptions And Problems (Mondaq)

US: Pharmaceuticals and Biotechnology

  • FDA Rescinds Tentative Approval for Ranbaxy’s Generic Nexium (Bloomberg) (Reuters) (FDA Law Blog)
  • J&J Wins U.S. Approval for Hepatitis C Combo With Gilead (Bloomberg) (Press) (PharmaTimes) (SCRIP-$) (BioCentury)
  • Lilly wins expanded use of Cyramza in gastric cancer (SCRIP-$) (Press)
  • Aeterna shares halve after FDA rejects growth hormone test (Reuters)
  • IPCA Labs' USFDA woes raise huge concern (Business Standard) (DNAindia)
  • Courtroom Drama Over NEUPOGEN Biosimilar Spills Over to FDA With the First Petition Accompanied by a 505(q) Certification (FDA Law Blog)
  • MMRF, FDA, NCI to develop multiple myeloma master protocol (BioCentury) (Press)
  • FDA Issues Complete Response Letter for Aeterna Zentaris' Macrilen™ NDA in Adult Growth Hormone Deficiency (Press) (Fierce)
  • ICON Selected by the FDA to Develop New Patient-Reported Outcome Measure for Hospital-Acquired Bacterial Pneumonia Trials (Press)
  • On the Trail of Drug Risks: May problems with therapies show up post-FDA approval. Could mining electronic data and online chatter head off trouble? (ProtoMag)
  • ANDA Litigation: Patents Are Being Challenged Sooner, OxyContin Draws Most Fire (Pink Sheet-$) (Pharmalot) (FDA News-$) (Report) (Patent Docs)
  • FDA Asks Court To Stop Dietary Supplement Co. Sales (Law 360-$)
  • For the dying, state laws offer hope that critics call hollow (Modern Healthcare)
  • FDA AdComm to Review Cerexa's NDA for Ceftazidime-acibactam (FDA)
  • Merck takes steps to return Zilmax to U.S. cattle market (Reuters) (Fierce)
  • J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition (Pink Sheet-$)
  • FDA Helps Shut Down Steroid Distribution Network (WDTV)
  • Doctor Pleads Guilty to FD&C Act Misdemeanor Charges (DemingHeadlight)
  • Pfizer Nixes Pharmacists' Claims In Lipitor Pay-To-Delay Row (Law 360-$)
  • Takeda Litigation Against FDA Over Colcrys Moves Forward (Press)

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

  • Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV (Press)
  • GSK submits mepolizumab NDA, MAA in eosinophilic asthma (SCRIP-$) (Fierce)
  • Changes to late-stage breast cancer trial sends shares of Celldex plunging (BioFlash) (The Street)
  • Spark Therapeutics Receives FDA Breakthrough Therapy Designation for Its Lead Product Candidate, SPK-RPE65 (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Government watchdog promises to monitor device cybersecurity in FY 2015 (Fierce)
  • FDA Sued Over Detained Chinese Leg Braces (Law 360-$)
  • Dozens of lawsuits filed in growing counterfeit spinal screw implant scandal (Fierce)
  • How To Address The Top 3 Supplier Management Issues (MedDeviceOnline)
  • Recall for Hospira Power Supply That Doesn't Deliver Enough Electricity (FDA)
  • FDA Approves Dexcom Software with Artificial Pancreas Algorithm (Press)
  • Medtronic in high spirits over positive study results for drug-coated balloon (Fierce)
  • Covidien Announces Nine-Month Results of DURABILITY Iliac Study, Addition of Iliac Indication for EverFlex Stent System at VIVA 2014 (Press)

US: Dietary Supplements

  • FDA Touches Constitutional Nerve In Warning On Mixing Supplements, Drugs – NPA (Tan Sheet-$)

US: Assorted And Government

  • FDA Looks To Big Data To Protect Public Health (Information Management)
  • Rep. Upton Says 21st Century Cures Initiative to be Priority in Next Congress (E&C)
  • A Senate Flip Could Help 21st Century Cures Initiatives, Hinder Food Safety (IHP-$)
  • They Like Me! FDA's Success on Social Media (FDA)
  • Your Guide to Reporting Problems to FDA (FDA)
  • FDA Enforcement Report (FDA)

Upcoming Meetings

Ebola Outbreak

Europe

  • MHRA vaginal mesh implants report: benefits of use outweigh risks (MHRA)
  • Fresh look at plasticizers in devices: new EU opinion out for comment (Clinica-$)
  • EMA—a Pioneer Permanently At Bay (PharmExec)
  • What are the EU GMP Requirements for the Validation of Excel Spreadsheets? (ECA)

India

  • India: Developing Biosimilars In India: Prescriptions And Problems (Mondaq)

China

  • China Solicits Comments on Biosimilars Guideline (JDsupra)
  • Beijing Wants APEC to Push Chinese Trade Pact (AP)

Canada

  • Canadian firms fear release of "confidential" info under new law (SCRIP-$)

Clinical Trials

  • MMRF, FDA, NCI to develop multiple myeloma master protocol (BioCentury) (Press)
  • ICON Selected by the FDA to Develop New Patient-Reported Outcome Measure for Hospital-Acquired Bacterial Pneumonia Trials (Press)

General Regulatory And Interesting Articles

  • Can the Time a Drug is Administered Affect its Effectiveness? (PNAS)
  • App could crack fake antimalarial drugs market (Pharmafile)
  • The New Driver of Research: Venture Philanthropy (ProtoMag)
  • On the Challenges of Building Biobanks (ProtoMag)

Regulatory Reconnaissance #435 – 6 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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