Regulatory Recon: Merck Immunotherapy Superior to Chemo for NSCLC in New Study (16 June 2016)

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

In Focus: US

• Merck Extends Cancer Immunotherapy Reach to First-Line Lung Cancer (The Street) (Investor’s Business Daily) (FierceBiotech) (Reuters) (Press)
• Ultrasound Opens the Brain to Promising Drugs (MIT Technology Review)
• Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information (Focus) (SEC) (WSJ-$) (NY Times) (Bloomberg)
• FDA Issues Final Rule on Symbols for Device Labels (Focus) (FDA Law Blog)
• GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals (Focus) (Pink Sheet-$)
• State Initiatives to Control Medication Costs — Can Transparency Legislation Help? (NEJM) (Podcast)
• The Parasite Underground (NY Times Magazine)
• New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition (Focus) (Stat) (Reuters)
• CDER Asked To Shed More Light On Potential Monograph User Fees (Tan Sheet-$) (Focus)
• Merck’s Lantus Biosimilar Queued for an FDA Submission? (Big Molecule Watch Blog)

In Focus: International

• Roche’s Gazyvaro cleared in EU for follicular lymphoma (PharmaTimes) (Press)
• NICE rejects Roche’s Cotellic for melanoma (PharmaTimes) (Pharmafile)
• Boston Scientific wins UK NICE support for GreenLight laser therapy (Mass Device)
• EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations (Focus) (MedTechEurope)
• India’s e-pharmacy start-ups prove a bitter pill (Financial Times-$)
• Considerations for the development of Zika virus vaccines (ScienceDirect)
• International Council on Harmonisation Includes Generic Trade Organization (IGBA) for the First Time (FDA Life) (IGBA Statement)
• Austin Biotechnology hit with US FDA warning at Taipei facility (In-PharmaTechnologist)
• Polio Strain Found in Hyderabad, India, Prompts Vaccination Drive (NYTimes) (Reuters)
• China details outsourced manufacturing pilot program (BioCentury)
• Chinese pharma giant to build plant in Ethiopia (PharmaAfrica)
• Famar to buy Spain formulation plant from Roche (In-PharmaTechnologist)
• MSF asks India to reject higher IP bar at regional trade talks (Fierce)

US: Pharmaceuticals & Biotechnology

• CIRM Creates First of its Kind Center to Accelerate Stem Cell Development (CIRM)
• Janssen Hits GE Unit With Patent Suit Over Biosimilar (Law360-$)
• All five US-approved weight loss drugs help people lose 5% of weight (OnMedica)
• Value-Based Contracting Needs Federal Safe Harbors To Flourish, Lilly Says (Pink Sheet-$)
• Can Deep Learning Help Clinicians Predict Alzheimer's Disease? (IEEE Spectrum)
• Sanofi helps develop blinding label for clinical trials (Outsourcing-Pharma)
• What FDA's Drug Distributor Licensing Regs Should Address (Law360-$)
• Celgene stock edges higher amid $3 billion buyback announcement (CNBC)
• A convergence model driven by real world intelligence (BioPharmaDive)
• People can choose their colon cancer screening method: U.S. panel (Reuters) (MITA)
• Almac facility successfully passes FDA inspection (Outsourcing Pharma)
• Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data (Genomics Law Report)
• UniQure slides toward historic lows after its hemB gene therapy goes up against Spark (Fierce)

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

• Stem cell factory opens doors for trials of personalized diabetes treatment (Stat)
• Systematic Review of 58 Publications of Real-World Use of Gardasil Presented at EUROGIN Congress (Press)
• Data Show Sigma Spectrum Infusion System Users Achieved 97 Percent Drug Library Compliance Rate Within the First Month of Implementation (Press)

US: Medical Devices

• Medtronic moves into pre-diabetes programs with Canary Health deal (MedCityNews)
• Ex-CDRH Compliance Leaders And Regulatory Experts Offer Tips For Surviving Face-To-Face Meeting With FDA (Gray Sheet-$)
• ProteXsure Safety Capsule System Cleared by FDA (Medgadget)
• 4tech launches transcatheter tricuspid valve repair feasibility trial (MassDevice)
• Philips Respironics launches patient adherence system (MassDevice)
• Silk Road touts TCAR study data (MassDevice)
• As Walgreens dumps Theranos, Quest moves into more Safeway locations (MedCityNews)
• Frenova discloses F1RST Up clinical trial accelerator participants (MassDevice)
• A Formula for a New Device Idea (MDDI)
• Allergan touts FDA acceptance of 510(k) application for Xen IOP reducing gel shunt (MassDevice)
• Suit claims Intuitive’s da Vinci caused metallic microemboli in patient’s brains (MassDevice)
• W.D. Penn. Dismisses Most Claims in Hernia Mesh Case (Drug and Device Law)

US: Assorted & Government

• Yes, Obamacare Premiums Are Going Up (NYTimes)

Upcoming Meetings & Events

• RAPS' FDA Advisory Committee Meeting Tracker
• FDA: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting – 28-29 June 2016

Europe

• UK pharmacist elected next president of Pharmaceutical Group of the European Union (Pharmaceutical Journal-$)
• EFPIA’s Annual Meeting: From Innovation to Outcomes (EFPIA)
• EBE, the European Biopharmaceutical Trade Association, Unveils Its Leadership 2016-2018 (EFPIA)
• The strife of Pii: UK MHRA finds GMP deviations at two facilities (In-PharmaTechnologist)
• David Murphy elected new Chair of EMA Committee for Medicinal Products for Veterinary Use (EMA)
• EU Pharma Told To Appoint 'Regulatory Contact' In EudraVigilance to comply with QPPV Rules (SCRIP-$)
• EU Council Blamed For Regulations’ Delay As EP Claims ‘Balanced Compromise’ (Clinica-$)
• Chinese dev LifeTech wins CE Mark for LAA closure device (MassDevice)
• Biotronik wins CE Mark for Magmaris bioresorbable scaffold (MassDevice)

Asia

• Korea Needs ‘More Unified’ Bio-Health Care Policy: Experts (PharmAsiaNews-$)

India

• Cardiac stent prices dropped but patients charged high : IMS Study (Economic Times)
• Govt to charge fees for inspection of imported drugs, drawing of samples for test at customs (PharmaBiz)
• Maharashtra FDA suspends Sequent Scientific’s Mahad unit licence (Economic Times)

Australia

• Medtronic deep brain stimulation therapy DBS Extension models 7483 and 37086 (TGA)
• Australian Survey Reveals Biosimilar Awareness, Switching Concerns (Pink Sheet-$)

Zika

• Letter to CDC Director from Texas governor over Zika (Letter)
• No birth defects seen in babies exposed to Zika late in pregnancy: study (Reuters)
• Zika Appears to Pose Less of a Threat to Fetus if Contracted Late in a Pregnancy (WSJ-$)
• Zika infection can damage fetuses even if pregnant women show no symptoms (Stat)

Other International

• Zimbabwe doctors say insurers owe 220 mln dollars, will now take cash only (Reuters)
• GE opens new training and skills institute committed for healthcare professionals (PharmaAfrica)

General Health& Other Interesting Articles

• Snapshots of Life: Arabidopsis Art (NIH Director's Blog)
• US diabetes patients living longer, more active lives (Reuters)
• With diabetes, losing weight lowers heart risks, even if you regain it (Reuters)
• Sleep apnea tied to heart risk even after arteries are cleared (Reuters)
• Listen: before you pop that Tylenol (Stat)

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.