Regulatory Focus™ > News Articles > Regulatory Recon: ALS Patients Battle With FDA Over Access to Experimental Drug (6 April 2015)

Regulatory Recon: ALS Patients Battle With FDA Over Access to Experimental Drug (6 April 2015)

Posted 06 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: ALS Patients Battle With FDA Over Access to Experimental Drug (6 April 2015)

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

In Focus: US

  • ALS patients press FDA for quick access to controversial biotech drug (Washington Post)
  • Pfizer: 'No biosimilar interchangeability in near future' (BioPharmaReporter)
  • Federal Circuit Rules that a Statutory Patent Disclaimer is Sufficient to Trigger Hatch-Waxman DJ Jurisdiction; Will It Be Enough to Trigger a Forfeiture of 180-Day Exclusivity? (FDA Law Blog)
  • FDA Looks To Duck Firm’s Suit Over J&J Risperdal Docs (Law 360-$)
  • Curating Services Help Patients, Docs Evaluate Mobile Medical Apps (MDDI)
  • FDA Classifies Bladder Device Into Class II (FDA)
  • Supplement Industry Fights Back Against State AGs (NewHope) (NewHope) (NI-USA)

In Focus: International

  • Will U.K. Politicians Pledge to Ban ‘Most’ Animal Research? (Pharmalot)
  • CDSCO asks health ministry to release Rs. 1600 cr under 12th Plan for strengthening regulatory apparatus (PharmaBiz)
  • Data manipulation: India contests EU charges against GVK Bio (Business Line)
  • CFDA Deputy Commissioner Moves To Sichuan (PharmAsia-$)
  • Opinion: It’s time to ensure medications are safe for children in Canada (Globe and Mail)

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US: Pharmaceuticals and Biotechnology

  • ALS patients press FDA for quick access to controversial biotech drug (Washington Post)
  • Pfizer: 'No biosimilar interchangeability in near future' (BioPharmaReporter)
  • Federal Circuit Rules that a Statutory Patent Disclaimer is Sufficient to Trigger Hatch-Waxman DJ Jurisdiction; Will It Be Enough to Trigger a Forfeiture of 180-Day Exclusivity? (FDA Law Blog)
  • FDA Looks To Duck Firm’s Suit Over J&J Risperdal Docs (Law 360-$)
  • DSCSA Deadline Represents A Crossed Threshold Into The Supply Chain Master Data Era (RxTrace)
  • Patient-Reported Outcomes To Be Available For ‘One-Stop Shopping’ In FDA Compendium (Pink Sheet-$)
  • A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion (PubMed)
  • Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference (PubMed)
  • Teva files new FDA petition against generic Copaxone (Global Times)
  • Aurobindo gets USFDA final approval for Sildenafil injection (Business Standard)

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

  • FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa (dabigatran etexilate mesylate) for the Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism After Hip Replacement Surgery (Press)
  • Alkermes Announces Positive Topline Results from Complete Six-Month Phase 2 Clinical Trial of ALKS 3831 in Schizophrenia (Press)
  • Astellas' Enzalutamide Demonstrates Statistically Significant Improvement In Progression Free Survival Compared With Bicalutamide In Strive Trial (Press)
  • Curis Announces Orphan Drug Designation for CUDC-907 in Diffuse Large B-Cell Lymphoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Puberty Suppression Now A Choice For Teens On Medicaid In Oregon (NPR)
  • The Justice Department's questionable battle against FedEx (CNN)
  • PTO Revising Patent Challenge Proceedings; PhRMA, BIO Helped Spur Change (Pink Sheet-$)
  • Pharma Moves From ‘Denial’ To ‘Acceptance’ Of Post-Grant Patent Challenges (Pink Sheet-$)

US: Medical Devices

  • Curating Services Help Patients, Docs Evaluate Mobile Medical Apps (MDDI)
  • FDA Classifies Bladder Device Into Class II (FDA)
  • FDA expands indication for On-X Life's heart valve (Mass Device)
  • FDA Expands Indication for EVARREST Fibrin Sealant Patch (Press)

US: Dietary Supplements

  • Supplement Industry Fights Back Against State AGs (NewHope) (NewHope) (NI-USA)
  • Similar to Ephedra Ban, FDA Could Remove Powdered Caffeine from Market, Regulatory Experts Say (NPI)
  • Can fish oil supplement hinder cancer treatment? (CBS) (CancerTherapyAdvisor) (Reuters)

US: Assorted And Government

  • EPA Proposes New Nanotechnology Manufacturing Regulation (EPA)
  • FDA Hiring Information Security Professional (Indeed)

Upcoming Meetings and Events

Europe

  • Will U.K. Politicians Pledge to Ban ‘Most’ Animal Research? (Pharmalot)
  • European Commission Approves Amgen's Vectibix (panitumumab) As First-Line Treatment In Combination With FOLFIRI Chemotherapy For Metastatic Colorectal Cancer (Press)

India

  • CDSCO asks health ministry to release Rs. 1600 cr under 12th Plan for strengthening regulatory apparatus (PharmaBiz)
  • Data manipulation: India contests EU charges against GVK Bio (Business Line)
  • Central scheme of free drugs gets a quiet burial (India Times)
  • Presence of impurities a serious threat to pharma manufacture & marketing: Dr AR Ramesh (PharmaBiz)

China

  • CFDA Deputy Commissioner Moves To Sichuan (PharmAsia-$)

Canada

  • It’s time to ensure medications are safe for children in Canada (Globe and Mail)
  • ARIAD Announces Approval of Iclusig (as Ponatinib Hydrochloride) in Canada (Press)

Other International

Clinical Trials

  • Challenges and opportunities in designing clinical trials for neuromyelitis optica (PubMed)
  • SACHRP Warns Part 11 Could Doom Electronic Informed Consent (Thompson's-$)

General Regulatory And Interesting Articles

  • Ancestry.com is quietly transforming itself into a medical research juggernaut (Fusion)
  • Mango Health’s Drug Prescription, Health Apps Eye The Ideal Spot On The Apple Watch (TechCrunch)

Regulatory Reconnaissance #529 – 6 April 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.


Categories: Recon, Regulatory News

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