Regulatory Recon: A Major Development for Orphan Drug Exclusivity Regulation (12 November 2014)

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

In Focus: US

• FDA Withdraws Appeal in the Depomed Case (FDA Law Blog) (What That Means)
• Indian Drugmakers see US sales hit by delay in new approvals (Reuters)
• Ipca clarifies 'gravity' of FDA inspection at Indore site (SCRIP-$)
• OIR Head Alberto Gutierrez Discusses Draft LDT Framework at Federal Laboratory Advisory Committee Meeting; Provides Additional Insights on Agency Plans to Regulate LDTs (FDA Law Blog)

In Focus: International

• Setting Standards for Biotech Therapeutics in India (Biopharm International)
• Indian Industry opposes PET ban, may challenge if govt refuses to withdraw same (PharmaBiz)
• Canada Passes a Drug Safety Law, but Criticism Persists (Pharmalot)
• EU/U.S. Trade Pact Talks May Stumble Over Drug Regulation, Affordability (Pink Sheet-$)
• NICE seeks more info on two med technologies (PharmaTimes)
• MHRA Opens One Stop Shop for Regenerative Medicine Information (Master Control)

US: Pharmaceuticals and Biotechnology

• FDA Withdraws Appeal in the Depomed Case (FDA Law Blog) (What That Means)
• Indian Drugmakers see US sales hit by delay in new approvals (Reuters)
• Ipca clarifies 'gravity' of FDA inspection at Indore site (SCRIP-$)
• FDA Funding Goes to Research Consortium Working to Improve Locally Acting Drugs (DD&D)
• DMD: Why a ‘miracle’ drug exists but you can’t have it yet (Mosaic Science)
• New USP Requirements on Plastic Packaging Systems (ECA)
• The History of FDA's Shirley Amendment (Pharma Letter-$)
• Par Pharmaceutical Announces First FDA Approval of Vasostrict (vasopressin injection, USP) (Press)
• FDA Mini Sentinel Evaluation of Buprenorphine Products (Mini-Sentinel)

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

• Amgen psoriasis drug tops J&J's Stelara in Phase III study (Reuters) (Press) (BioCentury)
• AbbVie Hepatitis C Drug Cures 97% in Transplant Patients Study (Bloomberg) (Fierce) (BioCentury) (PharmaPhorum)
• Merck's head-to-head Vytorin trial might be surprisingly flattering  (Fierce) (MM&M) (Pharmalot)
• Polyphor’s POL7080 receives QIDP designation from the FDA (PharmaLetter-$)
• Merck Looking To Phase III Trials As Pivotal Proving Ground For HCV Combo (Pink Sheet-$)
• No SAEs in dialysis study of Akebia's AKB-6548 (BioCentury)
• Acadia: Don't expect Nuplazid NDA until 1Q 2015 (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

• Strategies to reduce the use of antibiotics in animals (Pharm Journal)
• One In A Million: Aegerion Looks To Raise The Price Of Myalept (Pink Sheet-$)
• Major Medical Centers ask Congress to Probe Genentech Distribution Shift (Pharmalot)
• Study Shows T-Dap Vaccine Not Linked With Higher Risk of Pre-Term Birth (CBS)

US: Medical Devices

• OIR Head Alberto Gutierrez Discusses Draft LDT Framework at Federal Laboratory Advisory Committee Meeting; Provides Additional Insights on Agency Plans to Regulate LDTs (FDA Law Blog)
• PMAs Proposed For Dynamic Spine Stabilization Devices (Gray Sheet-$)
• French Drug Firm Bets on Tiny Diabetes Device (WSJ-$)

US: Dietary Supplements

• Post election committee shuffles emphasize need for industry engagement, observers say (Nutra Ingredients USA)

US: Assorted And Government

• Low Rates of HPV Vaccination Leads to States With High Rates of Cervical Cancer (LATimes)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker
• Super Important Biotech and Drug Stock Events for November (The Street)

Ebola Outbreak

• European responses to the Ebola crisis- Initiatives at the European Medicines Agency (Harvard BOH)

Europe

• EU/U.S. Trade Pact Talks May Stumble Over Drug Regulation, Affordability (Pink Sheet-$)
• NICE seeks more info on two med technologies (PharmaTimes)
• MHRA Opens One Stop Shop for Regenerative Medicine Information (Master Control)
• Stakeholder engagement in Value Based Pricing and Value Based Assessment (PharmaPhorum)
• Augmenix wins CE Mark for TraceIT marking agents (Mass Device)
• ViewRay Receives CE Mark for MRIdian MRI-Guided Radiation Therapy System (MedGadget)
• GlaxoSmithKline Announces EU Regulatory Submission for Severe Aplastic Anemia Indication for Revolade (eltrombopag) (Press)
• UK's world-leading genome project goes live (PharmaPhorum)

India

• Setting Standards for Biotech Therapeutics in India (Biopharm International)
• Industry opposes PET ban, may challenge if govt refuses to withdraw same (PharmaBiz)
• Apex committee on clinical trials gives approval to 33 proposals of clinical trials (PharmaBiz)
• Indian IPR think tank ticks all the wrong boxes? (SCRIP-$)
• Maha FDA cracks down inter state abortion drug racket, stocks worth Rs.3 lakh seized (PharmaBiz)

China

• China Agrees to Drop Trade Tariffs Against US Medical Devices (NYTimes) (Gray Sheet-$)

Canada

• Canada Passes a Drug Safety Law, but Criticism Persists (Pharmalot)

General Regulatory And Interesting Articles

• J&J's Super Weird Looking Light Therapy Mask (MedCityNews)
• Diagnosing glaucoma by watching your iPad? It could be here sooner than you think. (WaPo)
• Microbiome Studies Contaminated By Sequencing Supplies (Scientific American)

Regulatory Reconnaissance #439 – 12 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 [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.