Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Two Drugs for Rare, Fatal Lung Disease (16 October 2014)

Regulatory Recon: FDA Approves Two Drugs for Rare, Fatal Lung Disease (16 October 2014)

Posted 16 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Approves Two Drugs for Rare, Fatal Lung Disease (16 October 2014)

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

In Focus: US

In Focus: International

  • Dendreon's Provenge too expensive for NHS use, says NICE (PharmaTimes) (SCRIP-$) (PharmaPhorum) (Pharmafile)
  • Global regulators demanding needless drug quality levels, says Indian Gov (In-Pharma)
  • WHO’s Biologic Naming Plan Draws Questions Of Retroactive Naming, Use (IHP-$)
  • Trade Talk Documents Suggest Access to Medicines May Become Harder (Pharmalot) (KEI)
  • J&J offers Olysio cost-sharing in Scotland (BioCentury) (SCRIP-$) (MM&M)
  • Canada supplies small amounts of Ebola treatment to Spain, Norway (Reuters)
  • China sends thousands of doses of anti-Ebola drug to Africa (FT-$)

US: Pharmaceuticals and Biotechnology

  • InterMune and Boehringer win tandem FDA nods for 'breakthrough' lung drugs (Fierce) (The Street) (NYTimes) (Press) (Reuters) (Press) (PharmaPhorum) (Pharmafile)(BioCentury) (SCRIP-$) (FDA) (FDA) (FDA Voice)
  • ISPE Plan for Addressing Drug Shortages Focuses on Beefing Up Quality Systems (FDAnews-$) (ISPE)
  • Benefits of Novartis psoriasis drug outweighs risk: FDA staff (Reuters)
  • Design Defect Claim Against Branded Drug Preempted (D&D Law)
  • Generic Drug Cos. Seek Federal Preemption Of Reglan Claims (Law 360-$)
  • Citizen Petition Seeks Labeling Changes on Levaquin to Reflect New Safety Signals (FDA)
  • USP Debate on Proposed Guidelines for Handling Hazardous Drugs to Re-Open (USP)
  • FDA cracks down on Little City Dogs' compounded copies of popular pet meds (Fierce)
  • Supreme Court Struggles Over What Constitutes A ‘Fact’ In Copaxone Case (Pink Sheet-$) (AP) (SCRIP-$)
  • 9 Things You Need To Know From Frontline Investigation Of Antibiotics & Animals (Consumerist)
  • Former OGD Official Bob Pollack Moves to Melbourne Labs (Press)
  • Zydus Files Suitability Petition for Voriconazole Injection ANDA (FDA)
  • Is a Statutory Patent Disclaimer Sufficient Enough to Trigger Hatch-Waxman Declaratory Judgment Jurisdiction? Two District Courts Reach Opposite Conclusions (FDA Law Blog)
  • LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage (FDA)

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

  • Penn-Novartis team 'amazed' at remissions, durable responses in leukemia CAR-T study (Fierce) (Press) (NEJM) (BioCentury)
  • FDA Rejects Insys Therapeutics’ Dronabinol Oral Solution Application (WSJ-$)
  • FDA Denies Acura Pharmaceutials' Appeal Over Hydrocodone Bitartrate/Acetaminophen Tablets (Press)
  • Noven Announces Menopause Drug's Effects on Weight, Sexual Function (Press)
  • Insys Receives DEA Approval to Produce Pharmaceutical Cannabidiol -- Updates Status of Its Cannabinoid Program (Press)
  • Upcoming events: Edoxaban faces panel and elagolix endometriosis data (EP Vantage)

US: Pharmaceuticals and Biotechnology: General

  • Gilead’s Sovaldi: Shooting Star Instead of Blockbuster (RPM Report-$)
  • India's Ranbaxy to pay $40 million to settle Texas Medicaid pricing litigation (Reuters)

US: Medical Devices

  • New CDRH Initiatives for Product Development and Reimbursement Considerations (FDA Life) (FDA Life)
  • Assessing FDA Powers After A Failed 510(k) Rescinding (Law 360-$)
  • Medical Device Firm iTraumaCare Receives Expanded Indication from FDA For iTClamp® Hemorrhage Control System (Press)

US: Dietary Supplements

  • DSHEA Sheds Little Light On Distinguishing Old From New Ingredients (Tan Sheet-$)

Upcoming Meetings

Ebola Outbreak

  • Canada supplies small amounts of Ebola treatment to Spain, Norway (Reuters)
  • China sends thousands of doses of anti-Ebola drug to Africa (FT-$)
  • Chimerix Seeks FDA Approval for Phase II Clinical Trial on Ebola Patients (BioCentury)
  • U.S. health official allowed new Ebola patient on plane with slight fever (Reuters)
  • Obama promises ‘much more aggressive’ response to Ebola (The Hill)
  • Liberia thinks it needs 84,000 more body bags for the Ebola outbreak (Vox)

Europe

  • Dendreon's Provenge too expensive for NHS use, says NICE (PharmaTimes) (SCRIP-$) (PharmaPhorum) (Pharmafile)
  • J&J offers Olysio cost-sharing in Scotland (BioCentury) (SCRIP-$) (MM&M)
  • Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (EMA)
  • 50th Anniversary of the EDQM: Key outcomes from the international conference (EDQM)
  • The Gate Keeper: Dr. David Haslam, Chair of the UK's NICE (PharmExec)
  • EGA proposes to maintain the current INN system for biosimilars (Biosimilar News)
  • Food supplements are Europe's real counterfeit drug problem says AIFA expert (Outsourcing Pharma)

India

  • Global regulators demanding needless drug quality levels, says Indian Gov (In-Pharma)
  • Fixed Prices for 108 Drugs to Remain in Effect in India, High Court Rules (India Times)
  • India Close to Finalizing New Patent Application Examination Rules (PharmaBiz)
  • Commerce Ministry to meet DCGI, Pharmexcil to discuss exporters issue soon (PharmaBiz)

Other International

  • WHO’s Biologic Naming Plan Draws Questions Of Retroactive Naming, Use (IHP-$)
  • Trade Talk Documents Suggest Access to Medicines May Become Harder (Pharmalot) (KEI)

Clinical Trials

  • Reminder emails get researchers to report results (AllTrials)
  • AllTrials Wants WHO to Require Reporting of Clinical Trial Results (AllTrials)

General Regulatory And Interesting Articles

  • Blind man sees for first time with "bionic eye" (CBS)

Regulatory Reconnaissance #422 – 16 October 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.


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