Regulatory Recon: Third Biosimilar Application Sent to FDA (18 December 2014)

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

As a notice to our readers, Regulatory Focus and Regulatory Reconnaissance will be on holiday break starting 22 December 2014. We will return—well rested, we hope—on 5 January 2015 with a roundup of all the news we missed during those two weeks.

In Focus: US

• FDA To Review Apotex Biosimilar Of Amgen Blockbuster Drug (Law 360-$) (Pink Sheet-$) (Press) (BioCentury) (Press) (SCRIP-$)
• FDA AdComm to Review the First Biosimilar Proposed Through 351(k) Pathway (Tarius)
• FDA Releases Final Guidances on Submitting Drug Applications Electronically (FDA) (FDA)
• FDA Announces Patient-Centered Breast Cancer Meeting (FDA)
• US FDA issues Form 483 to Hovione API facility in Portugal (In-Pharma) (Press)
• FDA Approves Swimmer's Ear Drug Xtoro (MedPageToday) (RTT) (FDA)
• Report: FDA Hampering Investigations into Internet Pharmacies (Politico) (Relevant Section)
•  ‘An Invisible Profession’: Scarcity Of Quality/Regulatory Experts A Call To Action For Educators (Silver Sheet-$)
• A Year of 510(k) Tumult (MDDI)
• Early Communications with FDA – When, Why, Who and How? (MedicalDeviceSummit)

In Focus: International

• AstraZeneca first-in-class ovarian cancer drug wins EU approval (Reuters) (Press)
• EU's top court opens door to some stem cell patents (Reuters)
• President Juncker appoints Special Adviser for Better Regulation (Press)
• Novartis sues India's Cipla over respiratory drug Onbrez (Reuters) (Fierce)
• China approves experimental Ebola vaccine for clinical trials (Reuters)

US: Pharmaceuticals and Biotechnology

• FDA AdComm to Review the First Biosimilar Proposed Through 351(k) Pathway (Tarius)
• FDA Releases Final Guidances on Submitting Drug Applications Electronically (FDA) (FDA)
• FDA Announces Patient-Centered Breast Cancer Meeting (FDA)
• US FDA issues Form 483 to Hovione API facility in Portugal (In-Pharma) (Press)
• Meetings: Serious Drug-Induced Liver Injury -- The Importance of Getting It Right -- How to Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses (FDA)
• Swimmer's Ear Gets New Drug: FDA approves Xtoro (MedPageToday) (RTT) (FDA)
• Sticking With The Program: PDUFA V Review Changes Appear To Be Working (Pharma Approvals Monthly-$)
• Protecting the Public from Unsafe Compounded Drug Products (FDA)
• Report: FDA Hampering Investigations into Internet Pharmacies (Politico) (Relevant Section)
• GPhA, Health Groups Argue Leaked TPP Draft Hinders Generic Competition (FDAnews-$)
• FDA Sends Draft Guidance on OOPD Meetings to OMB (FDA)
• FDA Sends Draft Guidance on Cooperative Manufacturing Arrangements to OMB (FDA)
• FDA Generics Office Hopes To Clear Unmeasured ANDAs (Pink Sheet-$)
• Impact of Interim Guidance on Business Method and Software Claims (PatentDocs) (BIO) (Law 360-$)
• Fed. Circ. Strikes Down More Myriad Cancer Test Patents (Law 360-$)
• FDA's $1.2M Grant Extends ARA, NCTR Research into Graphene (Arkansas Business)
• FDA Estimates 81 Requests for Fast-Track Designation Each Year (FDA)
• Justice Department Drops Drug Misbranding Case (Kaiser)
• Court Says Bayer Filed a Whilstleblower (SCOUT)
• FDA Wants to Learn More About API Manufacturing (FDA)
• Tristar Equine Issues Voluntary Recall of Gastrotec (FDA)
• Advent, Avista Drop $1.5B Drug Co. Buy Amid FDA Scrutiny (Law 360-$)
• Woman indicted for phony cancer cures (DOJ)

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

• FDA To Review Apotex Biosimilar Of Amgen Blockbuster Drug (Law 360-$) (Pink Sheet-$) (Press) (BioCentury) (Press) (SCRIP-$)
• AbbVie Expecting HepC Treatment Decision by FDA Soon (WSJ-$)
• GlaxoSmithKline shingles vaccine hits goal in major study (Reuters) (Fierce)
• Right pathway, wrong drug? Roche's pictilisib trips up (PharmaTimes)
• Tetraphase spikes on a Phase III success for lead antibiotic (Fierce) (Reuters) (Press)
• Pharnext drug shows promise in neurological disease with no treatment (Reuters)
• Pfizer Reports Top-Line Results From a Phase 3 Study Evaluating Pregabalin Controlled-Release Formulation as a Treatment for Patients With Postherpetic Neuralgia (Press)
• Lundbeck pulls the plug on its fast-tracked stroke drug (Fierce)

US: Pharmaceuticals and Biotechnology: General

• Amgen's new leukemia drug to carry $178,000 price tag (Reuters) (Pink Sheet-$)(BioCentury) (SCRIP-$) (Bloomberg)
• Actavis' Stance On Namenda Is Harming Pharma's Image (Forbes)
• Senators urge stronger action against drug overdoses (The Hill) (Senate)
• Paying For Placebo Is ‘Biggest Change’ In Medicare CED Policy, Official Says (Pink Sheet-$)

US: Medical Devices

• ‘An Invisible Profession’: Scarcity Of Quality/Regulatory Experts A Call To Action For Educators (Silver Sheet-$)
• A Year of 510(k) Tumult (MDDI)
• Early Communications with FDA – When, Why, Who and How? (MedicalDeviceSummit)
• 12 Things You Should Never Say To FDA During An Inspection (Silver Sheet-$)
• Quidel Receives Simultaneous FDA Clearance and CLIA Waiver for Its Sofia Strep A+ Fluorescent Immunoassay (FIA) via the FDA's New Dual Submission Program (Press)
• Ex-Abbott stent liaison alleges retaliation for compliance complaint (MassDevice)
• Cohera Medical, Inc. Receives Priority Review Status Designation from FDA for Sylys Surgical Sealant (Press) (BizJournal)
• ReFlow Medical Corporation Announces FDA 510(k) Clearance And Initial US Clinical Use Of The SpeX Shapeable Support Catheter (Press)

US: Dietary Supplements

• Infant Death Triggers FDA Health Provider Warning On Probiotic Risks (Forbes)
• Nutrition Foundation Sues FDA, Seeking Ruling on Soy Protein Health Claim Petition (FPD) (Press)

Upcoming Meetings

• RAPS' FDA Advisory Committee Meeting Tracker
• 5 Critical Biotech Drug Dates and Events for December (24/7 Wall Street)

Ebola Outbreak

• China approves experimental Ebola vaccine for clinical trials (Reuters)
• Over 50 FDA Approved Medications Can Help Battle Ebola Infection (Press) (Press)

Europe

• AstraZeneca first-in-class ovarian cancer drug wins EU approval (Reuters) (Press)
• EU's top court opens door to some stem cell patents (Reuters)
• EU abandons draft price transparency directive (SCRIP-$)
• Data transparency in Europe: Will 2015 usher in a new era? (PMLive)
• U.K. may allow embryos with DNA from 3 parents (AP)
• EU ministers agree to keep on sharing pricing information (SCRIP-$)
• PhUSE Registered as Member of EMA Stakeholder Database (Press)
• President Juncker appoints Dr Edmund Stoiber Special Adviser for Better Regulation (Press)
• U.K. wants to catapult precision medicine (BioCentury)
• MHRA Recalls "Faulty" Insulin Pens (MHRA)

India

• Novartis sues India's Cipla over respiratory drug Onbrez (Reuters) (Fierce)
• Clinical trial regulations to be developed through consultative approach (PharmaBiz)

China

• China approves experimental Ebola vaccine for clinical trials (Reuters)

Australia

• Declaration that certain IVDs are medical devices (TGA)
• TGA Launching New Payment System in 2015 (TGA)

Clinical Trials

• The Proposed NIH Framework for Clinical Trials Registration and Results Reporting: A Closer Look (FDA Law Blog)
• Reimbursement Consequences for Clinical Trials: Twice the Pressure on Getting it Right (Context Matters)
• 2014: The year of influence for AllTrials (AllTrials)

General Regulatory And Interesting Articles

• Ever Wondered Who’s Behind Those Viagra Emails? The dark and deadly world of pharma spam (Politico)

Regulatory Reconnaissance #462 – 18 December 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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