Regulatory Recon: CHMP Recommends Six Medicines for Approval FDA Panel Backs Sentinel Cerebral Protection System (24 February 2017)

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

In Focus: US

• FDA Panel Says Yes to Sentinel Cerebral Protection System (Medpage)
• FDA Ain't Broke, Doesn't Need Fixin' (Morning Consult)
• Approving new drugs (Science)
• Death in trial of Roche's potential blockbuster hemophilia drug (Pharmafile) (EP Vantage) (Fierce)
• Merck drug prevents serious infection after marrow transplant: study (Reuters)
• On Tap: Novel Agents Awaiting US FDA Action In 2017 (Pink Sheet-$)
• Novel US FDA Approvals Could Rebound In 2017: 40+ Candidates Already Under Review (Pink Sheet-$)
• You're Overpaying for Drugs and Your Pharmacist Can't Tell You (Bloomberg)
• ICER Revising Drug Review Criteria, Will Use Net Prices, Broad Evidence Base (Pink Sheet-$)
• Ovarian Cancer Drugs Will Get ICER Review As Olaparib's Maintenance Indication Looms (Pink Sheet-$)
• FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information (Focus)
• One more time: We're not buying Valeant, Allergan CEO insists (Fierce)
• Sixth Circuit Affirms Branded Drug Preemption and Trial Win (Drug & Device Law)
• FDA won't do that: Cybersecurity edition (Medical Design & Outsourcing)
• FDA Expands Use of Procalcitonin Test to Help Guide ABX Use (MedScape) (FDA)
• FDA OKs Rapid Test for Bloodstream Infections, ABX Choice (MedScape) (FDA)
• After Dust Up Over Emflaza's Price, Ubl Says PhRMA-Member Review Should Be Done In Matter Of Weeks (IHP-$)
• This Company With Anti-Aging Drug Is Secretly Preparing For Trump's New FDA (Forbes)
• VP Pence: 'America's Obamacare nightmare is about to end' (Washington Post) (Politico)
• Cancer patients, survivors fear GOP efforts to dismantle the Affordable Care Act (Washington Post)
• AARP, AHIP, And Others File Amicus Briefs In Sandoz V. Amgen (Big Molecule Watch)

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In Focus: International

• CHMP Recommends Six medicines recommended for approval, including one orphan (EMA)
• Final Versions of EU MDR, IVD Released, Voting Begins Next Month (Focus)
• Managing intellectual property to develop medicines for the world's poorest (Nature)
• Novartis wins CHMP nod for drug combo against some lung cancers (Reuters)
• AstraZeneca's FDA delayed ZS-9 gains European thumbs-up (Fierce)
• India's Pharma Barons Are Reporting Delays in Digitizing Labs (Bloomberg)
• European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (Focus)
• Redacting Personal Data/CCI In EU Clinical Trial Inspection Reports On The Agenda (Pink Sheet-$)
• Manchester mulls paying for medicines based on their efficacy (Financial Times) (PharmaTimes) (ABPI)
• Busy In-Tray Awaits New EFPIA Boss Nathalie Moll (Pink Sheet-$) (EFPIA)
• Stada's first real bidder has put up a $3.7B offer. Will a bidding war follow? (Fierce) (Press)
• To Test Zika Vaccines, Scientists Need A New Outbreak (NPR)
• Innovative medicines for Europe – Dr Martina Schüssler-Lenz of the Paul-Ehrlich-Institut elected chair of the EMA Committee for Advanced Therapies (Paul-Ehrlich-Institut)
• First hormone replacement therapy for parathyroid disorder (EMA)
• Submissions received: Guidance on risk management plans for medicines and biologicals (TGA)

US: Pharmaceuticals & Biotechnology

• Spectrum Pharma Investors Sue Over Rejected FDA Advice (Law360-$)
• Making (good) deals is hard to do, Gilead CEO says, but he's working on it (Fierce)
• Ex-GSK SVP instated as CMO at PureTech (Pharmafile)
• 2017 Sees 7 First Generics in the First 45 Days of the Year (Lachman Consultants)
• PPA: 2016 in review (PhRMA)
• "Off-label" antidepressant use is common, but is it safe? (CBS)
• Aveo takes baby step forward for once-rejected tivozanib (Fierce)
• Ronald E. Blaylock Elected to Pfizer's Board of Directors (Press)
• Rise in mumps outbreaks prompts U.S. officials to weigh third vaccine dose (Washington Post)
• The Demise Of The Erectile Dysfunction TV Ads (Forbes)
• Celgene president, COO Jackie Fouse to make shock departure (Fierce)

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

• Cempra's bacterial skin infection drug succeeds in key study (Reuters)
• Phase 3 Trial Data Show Use of SpaceOAR® Hydrogel Helps Maintain Erectile Function Following Prostate Cancer Radiation Treatment (Press)
• Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant (MassDevice) (Press)
• GlaxoSmithKline, Innoviva tout data for Relvar Ellipta inhaled drug combo (Drug Delivery)

US: Medical Devices

• The Annual MQSA Inspection: What Facilities Can Do To Help (FDA)
• Teleflex wins FDA nod for Trapliner cath, sees shares rise on Street-topping Q4, FY2016 earnings (MassDevice)
• New Solitaire(TM) Stent Retriever Study Validates Outcomes and Real-World Application of Stroke Treatment Best Practices (Press)

US: Assorted & Government

• FDA: NECC Steroids Not Properly Sterilized (The Tennessean)
• Hemp Industries Association Seeks Contempt against DEA; Alleges Violation of 2004 Hemp Order (FDA Law Blog)
• Ex-Valeant, Philidor Execs Deny $40M Kickback Scheme (Law360-$)
• Merck Sued In Philly Over Shingles Vaccine Injuries (Law360-$)
• Fatal drug overdoses in US on the rise, CDC says (STAT) (CNBC)
• US House Committee Presses Drug Czar on Fentanyl (WSJ)
• VA Governor signs bills aimed at stemming opioid epidemic (Washington Post)

Upcoming Meetings & Events

• FDA Advisory Committee Calendar

Europe

• Medtronic lands CE Mark for quad MRI-safe pacers (MassDevice) (Press)
• Truxima fires the starting gun in biosimilar race to the bottom (EP Vantage)
• Developing talent and partnership to create new medicines (Pharmafile)
• LivaNova to exit London Stock Exchange (MassDevice)
• Advertising investigations: January 2017 (MHRA)

Asia

• Daiichi Sankyo announces structural changes (PharmaLetter-$)
• CFDA Minister Bi Jingquan meets German Ambassador to China (CFDA)

India

• India making major strides in vaccine development and safety (PharmaLetter-$)
• India's NPPA identifies 634 non-compliant drug pricings (Pharmafile)
• Gujarat FDCA seizes spurious products from two retailers (PharmaBiz)
• Zydus Cadila to launch seasonal flu vaccine in India (Economic Times)
• Karnataka drugs control dept all set for monitoring stent prices across hospitals in state (PharmaBiz)
• NPPA sends show cause notices to hospitals over stent overpricing allegations (Economic Times)

Canada

• New company, Fusion Pharmaceuticals, set up in Canada (PharmaLetter-$)

General Health & Other Interesting Articles

• First Magnetic Resonance Microscope Has Human Biochemistry in Its Sights (MIT Technology Review)

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 @Michael_Mezher or send him an email at [email protected].

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