Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves New Drugs to Treat MS, Eczema (29 March 2017)

Regulatory Recon: FDA Approves New Drugs to Treat MS, Eczema (29 March 2017)

Posted 29 March 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves New Drugs to Treat MS, Eczema (29 March 2017)

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

In Focus: US

  • FDA Approves Roche's Ocrevus as First Drug to Treat Severe Multiple Sclerosis (NYTimes) (Reuters) (WSJ) (FDA) (Press)
  • Sanofi, Regeneron Eczema Drug Approved by FDA; Price Tag is $37,000 a Year (NYTimes) (Reuters) (WSJ) (Forbes) (FDA) (Press)
  • Vertex cystic fibrosis combination succeeds in late-stage trials (Reuters) (WSJ) (EP Vantage) (Financial Times) (Press)
  • FDA Nominee Scott Gottlieb Plans Recusals From Decisions on Many Drug Firms, Lists Millions in Payments From Industry in Disclosure Forms (WSJ) (NYTimes)
  • Trump's FDA Nominee Wants to Lower Drug Costs With More Generics (Bloomberg)
  • Former FDA commissioner Mark McClellan comments on Trump's appointee to lead the agency (The Chronicle)
  • US senator launches probe into five top opioid drugmakers (Reuters) (Washington Post)
  • NIH Director Collins Downplays Budget Worries (Bloomberg)
  • Trump tells lawmakers he expects deal 'very quickly' on healthcare (Reuters)
  • Repeal of Affordable Care Act Is Back on Agenda, Republicans Say (NYTimes) (Reuters)
  • Those Indecipherable Medical Bills? They're One Reason Health Care Costs So Much. (NYTimes)
  • PhRMA report pins consumers' pain from high drug prices on health plans (STAT)
  • As blockbuster drugs fizzle, biotech looks warily to the next big thing (STAT)
  • Hope for devastating child disease comes at a cost: $750,000 a year (Boston Globe)
  • FDA in India – Championing a Culture of Quality (FDAVoice)
  • How Trump plans to combat the opioid crisis, starting this week (Politico)
  • FDA, Mylan silence on generic Advair may be good news for GSK (Reuters) (Fierce)
  • Mylan Hires Former SEC Commissioner for Chief Legal Officer Position (The Street)
  • Senate HELP Committee to Hold Second Hearing on User Fee Agreements on 4 April (Senate HELP)

In Focus: International

  • WHO Launches Global Effort to Halve Medication-Related Errors in 5 Years (WHO)
  • Corruption Prosecutors Investigate Novartis (Balkan News Agency)
  • EMA Expanding Use Of Early Background Summaries To Support Initial Drug Evaluations (Pink Sheet-$)
  • EU rapid drug approval plan worries some national agencies (Reuters)
  • Astellas sells 16 products to LTL Pharma for $181 million (PharmaLetter-$) (SCRIP-$)
  • Cempra pulls EU antibiotic filing following EMA questioning (Fierce) (Press)
  • Brazil Works to Control Yellow Fever Outbreak, with PAHO/WHO support (PAHO)
  • UK biopharma industry looks to Switzerland ahead of impending Brexit (BioPharmaReporter)
  • Cuts to prescriptions aims to save UK £128 million annually (Pharmafile)
  • Canada To Have Patent Term Extensions Soon – And An Export Waiver (Pink Sheet-$)
  • New Korea Fund To Nurture Early Stage Biotech Start-Ups (Pink Sheet-$)
  • Meningitis outbreak in Nigeria kills 269 people (Reuters)

US: Pharmaceuticals & Biotechnology

  • Antibiotic Development: Limited Population Pathway In US Removes Barrier (Pink Sheet-$)
  • Antibiotic Incentives: Pfizer's Read Touts Exclusivity Voucher (Pink Sheet-$)
  • Regenerative Medicine: The Promise and Peril (NIH)
  • The Hidden Monopolies That Raise Drug Prices (Prospect)
  • A Tale as Old as Time: Examining Employer-PBM Rebate Relationships for Specialty Drugs (Drug Channels)
  • Specialty Pharmacies: Building Special Connections (American Health Leader)
  • New York spreads the news with $1.15 billion biotech plan (Nature)
  • Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (FDA)
  • Cannabis Drug Marinol To Get Reboot In Chewing Gum (Forbes)
  • Vantage Point – The new frontier in immuno-oncology: drug-device combos (EP Vantage)
  • Eleven Biotherapeutics: Taking on ADCs with targeted protein therapeutics (BioPharmaReporter)
  • Misery In Myelofibrosis: Pacritinib Setback A Boost For Jakafi (SCRIP-$)
  • Some Thoughts on the New Common Rule for Human Subjects Research (Genomics Law Report)
  • Egalet Announces U.S. Food and Drug Administration Does Not Object to Egalet's Distribution of Materials and Communications to Healthcare Professionals Regarding Abuse-Deterrent Properties of ARYMO™ ER via Intranasal Route (Press)
  • FDA Warns Northwestern University Clinical Investigator (FDA)

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

  • Merrimack initiates Phase 1 study of MM-310 in solid tumours (EPR)
  • Acorda Announces Long-Term Safety Data for CVT-301 (Press)
  • Ritter lactose intolerance phase 2b/3 hits endpoint—but only after it excludes 20% of patients from the analysis (Fierce)
  • Enrollment Commences In Phase III Clinical Study Of Eisai's BACE Inhibitor Elenbecestat In Early Alzheimer's Disease In Japan (Press)

US: Medical Devices

  • FDA approves 1st-in-human trial for neural-enabled prosthetic hand (MassDevice) (Press)
  • Brain implant lets paralyzed man feed himself using his thoughts (Reuters)
  • Trumpcare's demise augurs ill for medical device tax repeal (MassDevice)
  • FDA Approves Myriad Genetics' BRACAnalysis as Complementary Dx for New PARP Inhibitor (GenomeWeb)

US: Assorted & Government

  • BIO Submits Amicus Brief Backing Amgen in Sandoz  Biosimilar Dispute (Big Molecule Watch)
  • Is a Hatch-Waxman 30-Month Stay Terminated if the Dismissal of a Patent Infringement Action is Later Vacated? FDA Says "No" (FDA Law Blog)
  • Court Rules that Prisoner is Entitled to Off Label Drug Treatment (Drug & Device Law)
  • Justice Department Joins Second Lawsuit Against UnitedHealth (NPR)
  • Supreme Court remands medical device patent cases (MassDevice)
  • Novartis Gets Partial Win In Transplant-Drug Patent Dispute (Law360-$)

Upcoming Meetings & Events

Europe

  • Large and small drugmakers sign up for Russia's serialization pilot (Securing Industry)

Asia

  • The 2nd Japan - India Medical Products Regulation Symposium (PMDA)
  • CFDA releases 2016 Annual Report for Medical Device Registration (CFDA)

India

Canada

  • Notice: Tablet Scoring of Subsequent-entry Pharmaceutical Products (Health Canada)

General Health & Other Interesting Articles

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 news@raps.org.

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


Categories: Recon, Regulatory News

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