Regulatory Focus™ > News Articles > Regulatory Recon: FDA OKs Allergan Glaucoma Stent, J&J's Darzalex for MM; Novo, Sanofi Face Off Afte

Regulatory Recon: FDA OKs Allergan Glaucoma Stent, J&J's Darzalex for MM Novo, Sanofi Face Off After Diabetes Approvals (22 November 2016)

Posted 22 November 2016 | By Michael Mezher 

Regulatory Recon: FDA OKs Allergan Glaucoma Stent, J&J's Darzalex for MM Novo, Sanofi Face Off After Diabetes Approvals (22 November 2016)

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

In Focus: US

  • Could the FDA be dismantled under Trump? (STAT)
  • Lawmakers close to finishing new Cures package (Politico)
  • The time to act is now: Bipartisan action will accelerate cures for Americans (The Hill)
  • Lawmakers must ask tough questions about the 21st Century Cures Act (The Hill)
  • Quick FDA approval for Darzalex in second-line MM (Press) (BioCentury) (FDA)
  • FDA clears Allergan's Xen gel stent for glaucoma (Drug Delivery) (Press)
  • Novo, Sanofi go head to head as FDA clears new diabetes drugs (Reuters) (Novo) (Sanofi)
  • Pharma Experts Cautiously Optimistic About Industry's Regulatory Challenges (Thomson Reuters)
  • Mylan refuses to testify at Senate hearing about EpiPen rebates to Medicaid (STAT)
  • Grassley Considers Subpoenaing Witnesses To Testify At EpiPen Hearing (IHP-$)
  • Mylan, Par, Others Rigged Divalproex Sodium ER Prices: Suit (Law360-$)
  • Final GDUFA Guidance Clarifies Penalties for Unpaid User Fees (FDANews-$) (FDA)
  • Another Worry for Compounding Pharmacies – The OIG Plans to Take a Look At Them! (Lachman Consultants)
  • FDA lifts hold on AstraZeneca head and neck cancer trials (Reuters) (PharmaTimes) (Fierce)
  • Drug combo may cause bleeding for patients with irregular heartbeat (Reuters)
  • Population Health Offers Three Critical Lessons For The Future Of Our Country, Part I (Forbes) (Washington Post)
  • Trump's Win Puts Medicaid Expansion On Hold In Red States (Forbes)
  • No sleep before San Diego: ASH late-breaking abstracts are released (BioWorld) (ASH)
  • FDA Begins Consultation On Update To ICH Pediatric Clinical Trials Guidance (Focus)
  • FDA Warns Boston Company For Selling Unapproved Biologic To Prevent Peanut Allergies (Focus)
  • Kickback Case Questions Whether Valeant Was Victim or Participant (NYTimes)
  • Transparency and Direct-to-Consumer Genetic Testing Companies (Harvard Bill of Health)
  • Divorcing Reimbursement From Real-World Prices: Medicare Still Uses 2003 AWPs For Some Drugs (Health Affairs)

In Focus: International

  • Fears raised over Google's DeepMind deal to use NHS medical data (Financial Times)
  • EMA Offers New Guidance On Type II Variations And MA Extensions Of Orphan Drugs (Focus)
  • GSK Strategy Chief: No Major M&A Likely In 2017 (SCRIP-$)
  • Amid Brexit Chaos, UK PM Promises More R&D Funding, Lower Taxes, And Other Pro-Innovation Measures (SCRIP-$) (PharmaLetter-$) (Pharmafile)
  • In the Battle Against Zika, Researchers Prepare for a Marathon (MIT Technology Review)
  • Currency drop hits Egypt's medicine supplies, angering public (Reuters)
  • Global standards for Zika testing needed, doctors say (Reuters)

US: Pharmaceuticals & Biotechnology

  • Purdue Hints At Large Acquisition In Coming Weeks (SCRIP-$)
  • The Convergence of Information Technology and the Life Sciences (Xconomy)
  • Five Important Themes to Watch in the Reform of FDA's Off-Label Communications Policy (National Law Review)
  • Precision medicine will increase drug prices and that's a good thing (MedCityNews)
  • Shire plots rare disease 'innovation hub' in Kendall Square (Fierce)
  • Basics of Biologics Price Competition and Innovation Act (National Law Review)
  • FDA's Sunscreen Guidance outlines safety and effectiveness data recommended for additional active ingredients (FDA) (Guidance)
  • Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance (FDA)
  • Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance (FDA)
  • Parents of children with cancer see income dips and loss of employment (Reuters)
  • US FDA Review Management Challenged After Spate Of Complete Response Letters (Pink Sheet-$)
  • Antibiotic Resistance Grows as Last-Line Drugs Fail (GEN)
  • Two vs Three Doses of Human Papillomavirus Vaccine (JAMA) (Study)
  • How to regulate precision medicines (Healthcare Economist)
  • Stockwatch: The Post-Truth Biopharma Rally (SCRIP-$)
  • Ash delivers early for Selexys (EP Vantage)
  • AbbVie drops Halozyme formulation of blockbuster Humira after disappointing trial (Fierce)
  • Merck hopes ominous new Zostavax ad can scare up adult vaccination rates (Fierce)
  • ANDA Withdrawals Increase Faster Than Approvals (Pink Sheet-$)
  • MIT's Langer sells off excipients biotech to break into Biosimilar market (BioPharmaReporter)
  • Biotech breakthroughs that broke down (Fierce)
  • Another ANDA Submission Surge Begins (Pink Sheet-$)

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

  • New KEYTRUDA® (pembrolizumab) Data in Blood Cancers to be Presented at 58th Annual Meeting of the American Society of Hematology (Press)
  • Viralytics' anticancer virus aces checkpoint inhibitor combo trials (Fierce)
  • Kite Pharma to Present Interim Results from the ZUMA-1 Pivotal Trial of KTE-C19 in a Late-Breaking Session at the 2016 American Society of Hematology Annual Meeting (Press)

US: Medical Devices

  • Use Error Takes a Hit in New MDR Guidance (MDDI)
  • FDA Will Not Finalize Draft LDT Guidances in 2016 – But That's Not the End of LDT Regulation (FDA Law Blog)
  • FDA clears Ascensia's Contour Next One blood glucose monitor (MassDevice)
  • Medtronic shares slip on missed Q2 sales mark, lowered outlook (MassDevice)
  • SuperSonic Imagine wins expanded FDA nod for Aixplorer platform (MassDevice)
  • Devicemakers help hospitals save money in the OR and avoid lowering product prices (Modern Healthcare)
  • Baxter Presented Exploratory Research on the Removal of Inflammation-Related Molecules During Extracorporeal Blood Purification Therapy (Press)
  • NeuroStar launches real-world registry for TMS therapy in depression (MassDevice)

US: Assorted & Government

  • Kimberly-Clark Seeks To Freeze Gown Trial For Cert. Appeal (Law360-$)
  • If Republicans Repeal Obamacare, Ryan Has Replacement Blueprint (NPR)
  • Antitrust Trial for Anthem-Cigna Begins (WSJ)
  • Excellent TwIqbal Decision — Plaintiffs Need to Look for Some Enlightenment (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • French Competent Authority Provides Roadmap for Manufacturers as European Notified Body Numbers Decrease (Emergo) (Focus)
  • Proposal to make Nasonex Allergy Control Nasal Spray available without prescription. (MHRA)
  • Introduction of safety features in the packaging of medicinal products by February 2019 (FIMEA)
  • New Report From DITTA Underlines Its Commitment To Cybersecurity (COCIR)
  • Funding for age-related macular degeneration research campaign (UK DoH)
  • EMA's Guido Rasi fears loss of expertise from Brexit but hopes for common framework with FDA (PharmaLetter-$)
  • Spectranetics wins CE Mark for smaller Stellarex DCB (MassDevice)
  • NICE recommends faecal immunochemical tests for colorectal cancer (EPR)
  • Marketing authorisations granted in October 2016 (MHRA)
  • Parallel import licences granted in October 2016 (MHRA)

India

  • Fixing drug prices helped consumers save Rs 5,060 crore: Government (Economic Times)

Asia

  • How Might Turkey Contain Its Rising Health Care Bill? (Pink Sheet-$)
  • Hervé Gisserot given newly-created Asia Pacific role at GSK (PharmaLetter-$)
  • Revisions of PRECAUTIONS (FY2016) (PMDA)

General Health & Other Interesting Articles

  • Telling Mosquitoes Apart With a Cellphone (NYTimes)

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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