Regulatory Recon: Roche and Mylan Settle Dispute Over Herceptin Biosimilar EMA Suspends Marketing of Four Contrast Agents for MRI Images (13 March 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                          

• Scott Gottlieb Nominated by Trump to Lead FDA (Focus) (NY Times-$) (Nature News) (Forbes) (Endpoints) (Health Care Blog) (Sen. Alexander statement) (Sen. Murray) (Rep. DeLauro) (Public Citizen)
• Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution (FDA Law Blog)
• At Senate Dems Urging, FTC Investigating Mylan’s Role in EpiPen Price Hikes (HELP Committee) (Letter)
• Roche and Mylan settle a scrap over Herceptin, clearing path for the biosimilar (Endpoints) (Press)
• Possible Cures. Mystery Deaths. Daunting Costs. Can CAR-T Be Tamed? (Xconomy)
• FDA generic approvals in February: ‘not the jump we have hoped for’ (Lachman Consultants)
• Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’ (Health Affairs Blog)
• Amgen Warns Of ‘Chaos’ In High Court Biosimilar Clash (Law360-$)
• Price Transparency and all its warts (Health Care Blog)
• US immunization programs would be gutted under Republican health bill, experts say (BMJ)
• How Will People Who Are Already Sick Be Treated Under A New Health Law? (Kaiser Health News)
• GOP Health Plan Would Hit Rural Areas Hard (WSJ-$)
• CBO analysis of Republican health bill may sharpen resistance to measure (Reuters)
• Five Big Numbers to Look for in the CBO Report (NY Times-$)
• 'Repeal And Replace' Going Relatively Well For Pharma So Far (Pink Sheet-$)
• White House: Drug Pricing In Phase Three Of Health Reform Will Be FDA Reform (IHP-$)
• From “Hibernation” to Avoidance of Confusion on FDA’s Budget (Alliance for a Stronger FDA)

In Focus: International

• EMA experts meet with African regulators to discuss opportunities for collaboration (EMA)
• EMA’s PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions (EMA) (PRAC)
• UK Life Science Industry Presses Government On Need For Continued Regulatory Alignment Post-Brexit (Pink Sheet-$)
• China bird flu death toll rises to 161 in worst outbreak since 2009 (Reuters)
• Who for the WHO? (Financial Times)
• Lethal Opiates Delivered By Mail From China, Killing Addicts In The U.S. (NPR)
• The National Health Service (NHS) in England is standing on a burning platform? (Harvard Bill of Health blog)
• Report advocates for international reference pricing to lower drug costs in Australia (BioWorld-$)
• HPRA detains 673,906 dosage units of illegal medicines in 2016 (HPRA)
• The Russia Serialization Pilot Guideline (RxTrace)
• India’s CDSCO Drug Surveys Report (CDSCO)

US: Pharmaceuticals and Biotechnology

• Eczema drug from Regeneron tipped for blockbuster status (Financial Times-$)
• Of Abundance And Scarcity In Venture Capital (Life Sci VC)
• Merck and Pfizer prep for battle with SGLT2, combo diabetes filings (FiercePharma)
• Pfizer vet Germano makes quick exit from Intrexon as hands-on billionaire Kirk reorganizes biotech (Endpoints)
• Intrexon Creates Precigen, Inc. and Accelerates Strategic Review of Structural Options Related to Health Assets (Press)
• US Denials Of HCV Treatment Coverage Rising, Regardless Of Payer Type (Pink Sheet-$)
• Section 337 actions at the ITC: Another forum for pharma and biosimilars litigation? (Big Molecule Watch)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

• Amgen's Repatha lowers need for cholesterol-lowering procedure (Reuters)
• FDA orders Karyopharm to halt enrollment for all selinexor trials, citing incomplete safety warning (Endpoints) (FierceBiotech)
• Keeping Track: US FDA Accepts Ertugliflozin, Extends Reviews Of Abaloparatide, New Keytruda Claim (Pink Sheet-$)
• Radius faces delay on FDA review of abaloparatide (PharmaLetter-$) (BioWorld)
• Tocagen files to raise up to $86.3M for glioma and cancer candidates
• NIH extends PPD HIV research support contract until 2024 (Outsourcing-Pharma)
• Characterization of Non-Infectious Virus-Like Particle Surrogates for Viral Clearance Applications (Study)
• Mixed findings from ICER on targeted immune modulators for RA (PharmaLetter-$)

Medical Devices

• FDA: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display (Federal Register)
• FDA: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use (Federal Register)
• FDA: Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device (Federal Register)
• Medtronic Receives FDA Clearance for Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) with TruRhythm Detection (Press) (Mass Device)
• BioTime expands OpRegen dry-AMD trial with U.S. sites (Mass Device)

US: Assorted and Government

• Bernie Sanders: Trump Should Avoid a Bad Zika Deal (NY Times-$)

Upcoming Meetings and Events               

• FDA Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Federal Register)
• Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Workshop; Request for Comments (Federal Register)
• FDA and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (Federal Register)
• RAPS' FDA Advisory Committee Meeting Tracker

Asia

• Nepal reports severe H5N8 bird flu on farm: OIE (Reuters)

General Health and Other Interesting Articles

• Old-Style Chemo Is Still A Mainstay In The Age Of Targeted Cancer Therapy (NPR)
• When a Common Sedative Becomes an Execution Drug (NY Times-$)
• Amid Opioid Epidemic, Senator Warren Launches Survey of Massachusetts Treatment Facilities (Press)

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.

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