Regulatory Recon: FDA, EMA Look to New Frameworks to Combat Ebola (17-21 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is back from a long-weekend vacation and ready to bring you a special extended edition of Regulatory Recon capturing everything that happened while we were out of the office. Enjoy!

In Focus: US

• FDA studies show nearly half of LASIK patients report problems (Mass Device) (FDA)
• 510(k) Data Debated In Comments On FDA Draft Guidance (Gray Sheet-$)
• FDA approves abuse-deterrent labeling for Embeda (BioCentury) (FDA)
• FDA panel unanimously backs Novartis' psoriasis drug (Reuters) (Tarius) (Press)
• Michigan Signs 'Right-to-Try' Bill Into Law (CBS)
• FDA's Draft Guidance on Biologic Exclusivity Needs Revisions, Industry Groups Say (Bloomberg BNA)
• FDA Naming Delay Cut Short Exclusivity, Drugmaker Says (Law 360-$) (FDA Law Blog)
• Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts (Fierce) (BioCentury) (Tarius)
• FDA’s IT Network Found Vulnerable to Cyber-Attacks (FDA News-$)
• Drug and Device Companies Critical Of FDA's Guidance Development (Policy and Medicine)

In Focus: International

• FDA facing huge pressure as Ebola worsens (PharmaPhorum) (NationalJournal)
• EMA Working to Speed up Development of Treatments, Vaccines for Ebola (EMA)
• Ebola Treatments: FDA, NIH Developing New Clinical Trial Protocol (Pink Sheet-$)
• EU Biotechs Look To Standardize Biosimilar Labeling For Safety Reasons (Pink Sheet-$)
• EU Member States, Industry Not Ready Yet For New Clinical Trials Regime (Pink Sheet-$)
• EMA considers relaxing clinical trial rules for rare-cancer patients (BioPharmaDive)
• UK government backs unlicensed medicines for terminally ill (FT-$) (PharmaTimes) (Pharmafile) (PharmaPhorum)
• Departure of DG Sanco official adds to EU drug/device policy shift uncertainty (Clinica-$)
• India set to temper trial compensation rules (SCRIP-$)
• India Trying to "Clear Misconceptions" About Country's Regulatory Quality (PharmaBiz)
• Canada issues licenses for critical drugs hit by Apotex/IPCA import alert (In-Pharma)
• Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session (BioPharmaIntl)
• Just Seeing Charts And Graphs Makes Drug Claims More Credible (NPR)

US: Pharmaceuticals and Biotechnology

• FDA approves abuse-deterrent labeling for Embeda (BioCentury) (FDA)
• FDA panel unanimously backs Novartis' psoriasis drug (Reuters) (Tarius) (Press)
• Michigan Signs 'Right-to-Try' Bill Into Law (CBS)
• FDA's Draft Guidance on Biologic Exclusivity Needs Revisions, Industry Groups Say (Bloomberg BNA)
• Out-of-Hospital Medication Errors Among Young Children in the United States, 2002–2012 (Pediatrics) (Forbes) (Reuters)
• FDA Naming Delay Cut Short Exclusivity, Drugmaker Says (Law 360-$) (FDA Law Blog)
• FDA Issues Draft Guidance with Recommendations for Drug Sponsors Submitting Two-Phased Chemistry, Manufacturing, and Controls Technical Data (FDA) (Guidance)
• Patient-Focused Drug Development At 10: Where Does It Go From Here? (Pink Sheet-$)
• CDER’s Drug Quality Office Separates Oversight Of ‘New’ And ‘Lifecycle’ Products (Pink Sheet-$)
• The Patent Use Code Conundrum – or Why FDA Can’t Read (Patents) (PCM)
• FDA Suggests Reintroduction of Bovine-Derviced Heparin (Thomson Reuters)
• Pfizer Loses a Bet on Removing Serious Warnings From its Chantix Pill (Pharmalot) (Tarius)
• FDA’s Black Box Instant Replay: A Higher Standard To Remove (Pink Sheet-$)
• User Fees For Biomarker Qualification Might Improve Study Designs (Pink Sheet-$)
• Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts (Fierce) (BioCentury) (Tarius)
• Drugmakers Say Labeling Guidance Should Apply Only to New Drugs and Biologics (FDA News-$)
• FDA Implementation of the Expanded Access Program in the United States (AmJournal of Bioethics)
• Better Late Than Never? Congress, Courts May Address Limits On Disseminating 'Off Label' Medical Information (Forbes)
• BioSpecifics Technologies Corp. Announces FDA Approval of sBLA for XIAFLEX for the Concurrent Treatment of Two Dupuytren's Contracture Cords (Press)
• Building a Robust Patient Profile of Benefit-Risk in Your Community (FasterCures)
• Hospira says saline recall will not make shortage worse (Fierce)
• Is the FDA’s black box on estrogen too ‘alarming’? (OncologyPractice)
• Cadila Healthcare recalls blood pressure drug in the US (Business Standard)
• HART reveals death of artificial trachea patient (Mass Device)
• Natco Pharma's US partner gets FDA nod for wakefulness tablets (India Times)
• FDA Focus: The medical marijuana controversy (PharmaLetter-$)
• September 2014 Drug Safety Labeling Changes (FDA)

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

• Top 10 Phase III disasters of 2014 (Fierce)
• FDA accepts app for Merck, Sanofi 6-in-1 combo vaccine (Fierce)
• Amgen studying what impact switching to 'biosimilar' Aranesp has on patients (BioPharmaReporter)
• Analysts see U.S. approval of Novo Nordisk's obesity drug by year-end (Reuters)
• Repros plummets as the FDA deals a blow to its low-T hopes (Fierce) (Press)
• Eisai's Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures (MPR)
• FDA accepts Eli Lilly's filing of new drug application for empagliflozin/metformin fixed-dose combination (Press)
• Nexvet starts pivotal trial of pain-relieving antibody for arthritic dogs (Fierce)
• Results from Two Phase III Studies Added to U.S. Label of Genzyme’s Aubagio (Press)
• Omeros suspends mid-stage trial of Huntington's drug, shares fall (Reuters)
• Anoro's COPD Drug Shows Improved Lung Function (Press)
• Study Boosts Use of Viagra in Heart Disease (CBS) (Forbes)
• Regeneron's Eylea Shows Greater Visual Acuity Gain in DME Trial (MPR) (IBD)
• Pharmacyclics files Imbruvica sNDA for Waldenstrom’s macroglobulinemia (Press)
• Investigational Radiotracer Designated Orphan Drug for Neuroendocrine Tumors (MPR)
• First Detailed Look at Celgene Crohn's Disease Pill Impresses (The Street)
• Taiho Receives FDA Fast Track Designation for Colorectal Cancer Drug (Press)
• OctreoPharm Sciences Gets FDA Orphan Drug Designation for Management of Neuroendocrine Tumors (Press)

US: Pharmaceuticals and Biotechnology: General

• Opioid Deaths Finally Post Decline—But Heroin Deaths Rise (USA Today)
• Mylan faces investor pressures over use of drugs in US executions (FT-$)
• Addiction-riddled Kentucky out for blood in $1B suit against OxyContin-maker Purdue (Fierce)
• Lawmakers Urge HHS To Combat Rising Generic-Drug Prices (Law 360-$) (Letter)
• Senate Lawmaker Eyes Hearing on the Cost of Hepatitis C Treatments (Pharmalot)
• Shire Corporate Integrity Agreement: New Payment Disclosure Requirements (Policy and Medicine)
• Many U.S. women use custom-compounded hormones for menopause (Reuters)
• Patent Cases Down by 40% in 2014 (BIO)
• Prescription drug database poised to become law in Pennsylvania (Fierce)
• San Diego college students get antibiotics after one dies of meningitis (Reuters)

US: Medical Devices

• FDA studies show nearly half of LASIK patients report problems (Mass Device) (FDA)
• 510(k) Data Debated In Comments On FDA Draft Guidance (Gray Sheet-$)
• Hospital Glucose Meter Standard Not Recognized By FDA, Agency Clarifies (Gray Sheet-$)
• FDA Updates Website With Info on eCopy Program for Device Submissions (FDA)
• FDA approves Dexcom smartphone-enabled device for continuous glucose monitor (Fierce) (Press)
• FDA Greenlights Vesiflo’s Intraurethral Valve-Pump (Gray Sheet-$)
• FDA Approves TriVascular’s CustomSeal Technology (Gray Sheet-$)
• FDA clears AnthroTronix mobile app for PTSD, brain trauma assessment (Mass Device) (MobiHealthNews)
• Abbott granted 510(k) FDA clearance for two cataract surgery products (Press)
• FSC Laboratories, Inc. Announces FDA Clearance for Flexichamber, a Collapsible Anti-static Valved Holding Chamber (Press)
• West's Vial2Bag DC Device Receives U.S. FDA 510(k) Clearance and CE Mark (Press)
• Precision Spine Announces 510(k) Clearance Of The VAULT-C Anterior Cervical Interbody Fusion Device (Press)
• Experience With an Innovative New Food and Drug Administration Pathway for First-in-Human Studies : Carotid Baroreceptor Amplification for Resistant Hypertension (Elsevier)
• FDA Posts Materials From 3D Printing Meetings (FDA)
• New AdvaMed ‘Library Of Successful Quality Practices’ (Silver Sheet-$)

US: Dietary Supplements

• GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues (NutraIngredients)
• Dietary Supplements: Intended for Ingestion (Dietary Supplement Experts)
• CSPI Litigation Again Targets Bayer One A Day Claims (Tan Sheet-$)
• The research paper behind a favorite Dr. Oz product was just retracted (Vox) (CBS)
• Weight Loss Claims Land Firms On FTC Radar In First ‘Negative Option’ Case (Tan Sheet-$)
• AMS Health Sciences, LLC Issues Voluntary Recall of Saba Shark Cartilage Complex, 60 Capsule Bottles Due to Possible Salmonella Contamination (FDA)
• Adverse event reporting can provide valuable data to companies, expert says (NI-USA)

US: Assorted And Government

• FDA’s IT Network Found Vulnerable to Cyber-Attacks (FDA News-$)
• Drug and Device Companies Critical Of FDA's Guidance Development (Policy and Medicine)
• The Critical Path Initiative: 10 years later (BioPharmaDive) (Part 2)
• IRB Process Streamlining Expected In 21st Century Cures Bill (Pink Sheet-$)
• Fearing creation of deadlier viruses, US tells scientists to halt bird flu research (BioPharmaDive) (Forbes)
• Looking ahead at PTO (BioCentury)
• Could US handle biologic attack? (The Hill)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker

Ebola Outbreak

• FDA facing huge pressure as Ebola worsens (PharmaPhorum) (NationalJournal)
• EMA Working to Speed up Development of Treatments, Vaccines for Ebola (EMA)
• Roche may seek fast-track approval for Ebola virus test (Reuters)
• HHS puts third Ebola vaccine on the fast-track (BioPharmaDive) (AP)
• Ebola Threat Prompts EU To Focus On Adaptive Licensing (Pink Sheet-$)
• Chimerix Gets FDA OK to Test Drug for Ebola (Press) (Xconomy)
• Ebola Treatments: FDA, NIH Developing New Clinical Trial Protocol (Pink Sheet-$)
• US orders 3 state-of-the-art labs to ramp up Ebola drug ZMapp production (BioPharmaDive) (Reuters) (Guardian)
• Issues continue to dog the testing of Ebola drugs and vaccines (ScienceMag)
• Amgen working on alternative methods for Mapp's Ebola vaccine; Canada sends vaccine vials to WHO (PharmaLetter-$)
• Ebola Drug Race Ramps Up in Earnest (WSJ-$)
• GSK says Ebola vaccine too late for outbreak (PharmaTimes) (Reuters)
• Novartis responds to the Ebola outbreak (Press)
• Sarepta Therapeutics Climbs on Ebola Vaccine News (AP) (Press)
• EU Seeking to Create $1.27B Ebola Fund (Press)

Europe

• EU Biotechs Look To Standardize Biosimilar Labeling For Safety Reasons (Pink Sheet-$)
• EU Member States, Industry Not Ready Yet For New Clinical Trials Regime (Pink Sheet-$)
• EMA considers relaxing clinical trial rules for rare-cancer patients (BioPharmaDive)
• UK government backs unlicensed medicines for terminally ill (FT-$) (PharmaTimes) (Pharmafile) (PharmaPhorum)
• Departure of DG Sanco official adds to EU drug/device policy shift uncertainty (Clinica-$)
• Janssen's blood cancer drug Imbruvica approved in Europe (PMLive) (PharmaTimes) (BioCentury)
• EFPIA Pans New EU Clinical Trial Regulation (EFPIA)
• NICE backs Novartis' Glivec for GIST (PharmaTimes) (PharmaPhorum)
• Boston Scientific wins CE mark for MRI-friendly pacemaker products (Fierce)
• IonMed Receives CE Mark Clearance for Bioweld1 Cold Plasma System (Press)
• Europe's transparency vs privacy law: Titanic headed for iceberg? (SCRIP-$)
• UK watchdog warns of flood of counterfeit dental equipment (OnMedica)
• Price cut of 25% proposed for medicines on statutory scheme in England (PharmJournal)
• There’s an EU will on UDI, but there’s no way – yet (Clinica-$)
• Dutch regulators tighten scrutiny of medical apps and software (Clinica-$)
• European Pharma Group Opposes Spain’s Order Grouping Biosimilars with Generics (FDA News-$)
• Clanotech Receives Orphan Drug Designation in the EU (Press)

India

• India set to temper trial compensation rules (SCRIP-$)
• Bristol-Myers catches a break as Indian agency delays Sprycel patent decision (Fierce) (India Times)
• India Trying to "Clear Misconceptions" About Country's Regulatory Quality (PharmaBiz)
• Indian Government Supports Country-Specific Device Labels (Gray Sheet-$)
• Separate regulations needed for medical devices: AdvaMed (India Times)
• The US coaxing India to relax patent laws: MSF (BioSpectrum) (India Times)
• Insight On India – Highlights From The Week Of Oct 12-18, 2014 (24 Insight)
• Indians feel the pain of toxic hip implants (Al Jazeera)

Canada

• Canada issues licenses for critical drugs hit by Apotex/IPCA import alert (In-Pharma)

Australia

• WikiLeaks' free trade documents reveal 'drastic' Australian concessions (Guardian)
• Australia to Potentially Alter Regulation of Dietary Supplements (Nutra Ingredients)
• TGA Half-Year Performance Report (TGA)

Other International

• Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session (BioPharmaIntl)
• New Documents Posted by IMDRF (IMDRF)
• Quality probs and rising wages will see new API hubs replace China and India says analyst (Outsourcing Pharma)
• Medicine prices at risk under Pacific trade draft: critics (Reuters)

General Regulatory And Interesting Articles

• Just Seeing Charts And Graphs Makes Drug Claims More Credible (NPR)
• Parkinson’s drugs linked to impulse control disorders (Reuters) (Vox) (NPR)
• How a Wiki Is Keeping Direct-to-Consumer Genetics Alive (MIT TR)
• Product Snapshot: RegCheck (MedScrum)
• A bitter pill to swallow: young people dislike tablets more than old (Outsourcing Pharma)
• Tasmania’s grip on opium poppy industry weakens as plant moves north (Guardian)
• Paralysed man walks after stem cell breakthrough (OnMedica) (Reuters)

Regulatory Reconnaissance #423 – 17-21 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 [email protected].

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