Regulatory Focus™ > News Articles > Regulatory Recon: FDA Tentatively Approves Collegium Opioid, Cancer Centers to Pool Gene Data (9 Nov

Regulatory Recon: FDA Tentatively Approves Collegium Opioid, Cancer Centers to Pool Gene Data (9 November 2015)

Posted 09 November 2015 | By Michael Mezher 

Regulatory Recon: FDA Tentatively Approves Collegium Opioid, Cancer Centers to Pool Gene Data (9 November 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Collegium Gets Tentative FDA Approval for Opioid Painkiller (Reuters)
  • Robert Califf on Publishing Trial Data, FDA Standard-Setting, Patient Advocacy (Tan Sheet-$)
  • US Federal Agencies Investigate Merck, Lilly Drug Pricing (Reuters) (SCRIP-$) (PMLive) (Pink Sheet-$) (WSJ-$)
  • FDA panel votes unanimously in favor of Merck & Co's Sugammadex (Reuters) (Merck)
  • GDUFA II: Priority Reviews Considered For Some ANDAs (Pink Sheet-$)
  • Direct-to-consumer company tests FDA's resolve on gene testing (Reuters)
  • US Targets Pharmacies Over Soaring Claims to Military Health Program (WSJ)
  • Seven Major Cancer Centers to Pool Patients' Gene, Health Data (Xconomy)

In Focus: International

  • Joint NGO Statement on TRIPS Council Decision On Extension of the Transition Period Concerning Pharmaceutical Products (KEI)
  • UK Proposes New Pathway To 'Manage' Accelerated Access To Promising Drugs, Devices (SCRIP-$)
  • Sleepless Nights Over EU Labeling Rule For Investigational Drugs (Pink Sheet-$)
  • New Brazilian medical device regulations in effect (MassDevice)
  • Sierra Leone stops transmission of Ebola virus (WHO)

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US: Pharmaceuticals and Biotechnology

  • Dormant OTC Firm Warned On GMP Violations (Tan Sheet-$)
  • Rare Diseases: The Path To Precision Medicine (SCRIP-$)
  • Positive Phase III outcomes from Samsung Bioepis’ biosimilar candidates (Biosimilar News) (Press)
  • Duke Uni: Holy grail of HIV vaccine in sight using ‘paradoxical’ bnAbs (BioPharma-Reporter)
  • Lancet Sprints To The Front With A Blood Pressure Meta-Analysis (CardioBrief)
  • FDA's Biologics Naming Plan: Industry Wants 'Memorable' Suffixes (PinkSheet-$) (Focus)
  • Google, American Heart Association Announce Joint Research Effort (WSJ)
  • With Parity Pricing, Gilead Relies On Genvoya Safety To Convert From Stribild (Pink Sheet-$)
  • Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death (FDA)
  • Animal study shows benefit from gene therapy in late-stage eye disease (BioPharma-Reporter)
  • Tenofovir Linked with Acute Kidney Injury in HIV-Infected Patients (ICT)

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

  • Cytokinetics, Amgen drug shows promise in heart failure study (Reuters)
  • Novo Nordisk diabetes drug fails to help heart failure: study (Reuters)
  • FDA accepts Amgen's NDA for etelcalcetide, novel intravenous calcimimetic (PharmaLetter-$) (Press)
  • Onxeo Reports Initial Results of Phase 1 Trial Evaluating Belinostat in Combination with CHOP in Peripheral T-cell Lymphoma (Press)
  • Mirna Therapeutics Announces Presentation of Interim Data from Ongoing Phase I Clinical Trial of MRX34, First-in-Class microRNA-34 mimic, in Patients with Advanced Solid Tumors (Press)
  • Patients Show Significant Improvement in Signs and Symptoms of Psoriatic Arthritis, Less Progression of Structural Joint Damage When Treated with Ixekizumab for 24 Weeks (Press)
  • GSK's lupus drug Benlysta hits PhIII targets (PharmaTimes)
  • Sanofi And Regeneron Present Results From Pivotal Phase 3 Study Of Sarilumab At American College Of Rheumatology Annual Meeting (Press)
  • Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis (Press)

US: Medical Devices

  • FDA Investigators Now Assessing UDI Compliance When Inspecting Device Firms (Gray Sheet-$)
  • Theranos CEO Elizabeth Holmes needs to grow up, and fast (SF Chronicle)

US: Assorted and Government

  • CMS Wants To Facilitate Value-Based Discounts For HCV Drugs In Medicaid (Pink Sheet-$)
  • Op-Ed: I Am Paying for Your Expensive Medicine (NYTimes)
  • Sen. Hatch Says Drug IP Provisions May Doom TPP (Law360-$)
  • US senator's claims Australia is being greedy over trade deal rejected (The Guardian)
  • PhRMA Backs Merck In 3rd Circ. Over Nixed Fosamax Claims (Law360-$)
  • FDA Cracks Down On The Dietary Supplement Industry (Law360-$)

Upcoming Meetings and Events              

Europe

  • EMA Offers Road Map for Post-Approval Study Design (FDANews-$)
  • NICE consults on its first guideline on the safe use of controlled drugs (Pharmaceutical Journal-$)
  • FDA Official: Progress Seen in FDA-EMA Mutual Reliance Initiative (FDANews-$)
  • End of the road for Off-Patent Drugs Bill (PharmaTimes) (Pharmafile)
  • Governments and industry ‘combining to stall drug development’ (Pharmafile)
  • IQWiG backs limited use of Daiichi's Lixiana (BioCentury)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2015 (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5 November 2015 (EMA)

Canada

  • Updates to the Guidance Document: Fees for the Review of Drug Submissions and Applications (Health Canada)

India

  • India’s small-medium API units need suitable incentives to spur research & development (PharmaBiz)
  • UPFDA takes action against retailer for illegal sale of drugs online under Rule 65 of D&C Rules (PharmaBiz)
  • Three face FDA action for illegal sale of cough syrup (Economic Times)
  • SeQuent unit gets establishment inspection report from USFDA (Economic Times)
  • Glenmark gets FDA nod for generic fungal skin infections cream (Economic Times)

Other International

  • The Medicines Patent Pool Expands Mandate to Hepatitis C and Tuberculosis Treatment (PharmaAfrica)

General Health and Other Interesting Articles

  • Sleeping sickness breakthrough (OnMedica)

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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