Regulatory Focus™ > News Articles > Regulatory Recon: Obama Urges Development of Diagnostics, Vaccines for Zika (27 January 2016)

Regulatory Recon: Obama Urges Development of Diagnostics, Vaccines for Zika (27 January 2016)

Posted 27 January 2016 | By Michael Mezher 

Regulatory Recon: Obama Urges Development of Diagnostics, Vaccines for Zika (27 January 2016)

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

  • FDA Safety Reports: Firms Want Advance Notice Before Public Release (Pink Sheet-$)
  • Obama calls for rapid Zika research as virus seen spreading (Reuters) [Editor's Note: Scroll to the bottom of Recon for a full roundup of Zika virus news]
  • 2015 Medtech Approvals Highest in a Decade (MDDI)
  • Does Marketing Have Too Much Control In Big Pharma Clinical Trials? (Forbes)
  • Can Data Sharing Become the Path of Least Resistance? (PLoS)
  • AG calls on Gilead to lower price of hepatitis C medicines (BostonGlobe)

In Focus: International                    

  • Why 'big pharma' stopped searching for the next Prozac (The Guardian)
  • UK 'inadequate' at regulating off-label drugs (OnMedica) (MNT) (PLoS)
  • NICE backs five cancer drugs, spurns Cyramza (Pharmafile) (BioCentury)
  • Genetically Modified Mosquitoes Join The Fight To Stop Zika Virus (NPR)
  • ISO 9001 and ISO 13485: New Risk Management Requirements Present Challenges (MDDI)
  • GSK biopharmaceutical trade secrets defendant still "at large" (In-PharmaTechnologist)

US: Pharmaceuticals and Biotechnology

  • FDA's Warning Letters Show Quality Failures for Finished Drugmakers (FDANews-$)
  • Baxter Recalls Select Lots of IV Solutions for Potential Leaking and Particulate Matter (FDA)
  • US FDA Sets Goal For Biosimilar, Drug Promotion Guidances (SCRIP-$) (Focus)
  • Smoking cessation pill no better than nicotine patches or lozenges (Reuters)
  • How to Respond to FDA Inspection Observations, Including Those You Dispute (GxP Lifeline)
  • Here Are The Sticking Points For Biden, Big Data And Cancer Moonshots (Forbes)
  • Pharma Needs To 'Decide What It Wants To Be When It Grows Up' (SCRIP-$)
  • Opioids Do Not Improve Physical Function In Patients With Neuropathic Pain (Forbes)
  • Therapy focus – Merck and AbbVie still trail in Gilead's hep C wake (EP Vantage-$)
  • Pharma 'forced to innovate in patient recruitment and retention' (Pharmafile)
  • Is bioscience still getting lost in translation? (Pharmafile)
  • NGM Aims For Three Drugs In Clinical Trials, Padded By Cash From Merck (Pink Sheet-$)
  • New Mechanism of Antitumor Action Identified (DD&D)

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

  • Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence (Press)
  • Ophthotech Announces First Patient Dosed in Zimura Phase 2/3 Study to Evaluate Treatment in Patients with Geographic Atrophy, an Advanced Form of Dry Age-Related Macular Degeneration (Press)
  • BIND Therapeutics Provides Enrollment Update for Phase 2 iNSITE 1 and iNSITE 2 Trials with BIND-014 (Press)
  • Ipsen announces publication in Pediatrics of the results of the phase III randomized study showing the efficacy and safety of Dysport (abobotulinumtoxinA) in children with dynamic equinus foot deformity due to cerebral palsy (Press)
  • Boehringer Ingelheim's Giotrif/Gilotrif (afatinib) demonstrated superiority to Iressa (gefitinib) in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer (Press)

US: Medical Devices

  • FDA Extends Comment Period on Emerging Signals Guidance (FDA)
  • Class I Recall: St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads (FDA)
  • Judge boots Boston Scientific counterfeit mesh case to the FDA (MassDevice) (Law360-$)
  • FDA Counter-Offers On Industry CLIA Waiver Proposal (Gray Sheet-$)
  • FDA, Industry Agree On Working Groups To Support User-Fee Negotiations (Gray Sheet-$)
  • Is Machine Learning the Next Big Thing in Healthcare? (Part 1) (Geeks Talk Clinical)
  • Velano Vascular Receives Additional FDA Clearance for Innovative Blood Draw Device (Press)
  • ACT touts 1st-in-human trial for RF ablation tech (MassDevice)
  • Polyganics wins FDA 510(k) for Neurocap (MassDevice)
  • Contego touts post-market data for Paladin balloon (MassDevice)

US: Assorted and Government

  • Drug Assistance Programs Show Tightening Government Safeguards (Pink Sheet-$)
  • DOJ Makes History: On a Single Day It Files a Criminal Prosecution, a Consent Decree and a Criminal Forfeiture of Foods Involved in the Same Incident (FDA Law Blog)
  • Twofer Tuesday (Sorta) (Drug and Device Law)
  • Health Affairs In 2015: Editor's Picks (HealthAffairsBlog)
  • Gilead Hit With Suit In HIV Drug Patent Manipulation Row (Law360-$)
  • Otsuka Sues Orchid Pharma to Halt Generic Abilify (Law360-$)
  • 3rd Circ. Stays Provigil Pay-For-Delay Trial During Cert. Appeal (Law360-$)

Upcoming Meetings and Events              

Europe

  • France for resumption of India-EU FTA talks (Financial Express)
  • When can a Chemical Substance be qualified as a "New Active Substance"? The New Reflection Paper of the EMA gives Information (ECA)
  • Investigation into use of counterfeit and non-compliant equipment (MHRA)
  • Robotic Orthosis Helps Empower People with Duchenne Muscular Dystrophy (medGadget)
  • BioFire FilmArray Meningitis/Encephalitis Panel Gets CE Mark (GenomeWeb)

India

  • Priorities for India's health policy (Brookings)
  • Govt to sell 439 key drugs at low prices (Economic Times)
  • Sun Pharma and Lupin get tentative USFDA nod for schizophrenia drug (India Infoline)
  • Another Herceptin (Trastuzumab) Biosimilar Getting in Line in India (24 Insight)
  • Aurobindo Pharma gets USFDA nod for fungal infections tablets (Economic Times)
  • Pharma distributors ask govt to withdraw tenfold increase in licence fee for drug sales (Pharmabiz)
  • IDMA and UK-based NSF collaborate to train pharma QA heads on audit readiness for compliance to GMP, QMS (Pharmabiz)
  • KDPMA expects spurt in innovation in drug research and manufacture with Start-up India Campaign (Pharmabiz)
  • National Conference on medical devices & plastics disposables to be held on Feb 12-13, 2016 in Ahmedabad (Pharmabiz)

Canada

  • Health Canada Approves PrORKAMBI (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation (Press)
  • Actelion receives Health Canada approval for Uptravi (selexipag) for the long-term treatment of pulmonary arterial hypertension (MNT)
  • Telephus Medical LLC Announces Issuance of Canada Patent for Anti-MRSA Antibodies (Press)

Zika Virus

  • The Latest: Zika Case Detected in Arkansas Traveler (DD&D)
  • U.S. issues treatment guidelines for infants exposed to Zika (Reuters)
  • Brazil Will Deploy Troops to Spread Awareness of Zika Virus (NYTimes)
  • PAHO Helps Countries in the Americas Prepare for Spread of Zika (ICT)
  • Experts Say Zika Virus is a 'Game-Changer' for Mosquito-Borne Diseases (ICT)
  • Puerto Rico Zika report to show 18 cases: health secretary (Reuters)
  • Mosquitos Capable of Carrying Zika Virus Found in Washington, DC (ICT)
  • Why the United States is so vulnerable to the alarming spread of Zika virus (Washington Post)
  • Danish man tests positive for Zika virus after Brazil trip (Reuters)
  • Tropical Singapore, battling dengue, now warns of Zika virus (Reuters)
  • Virginia resident who traveled abroad tests positive for Zika virus (Reuters)
  • Mexico says 'no justification' for delaying pregnancies over Zika (Reuters)

Other International

  • Turkey Pursues Local Manufacture Of Hepatitis A Vaccine (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • Panel Calls for Depression Screenings During and After Pregnancy (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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