Regulatory Focus™ > News Articles > Regulatory Recon: FDA Posts New Agent in Singapore, CDC Issues Travel Advisory for Zika Virus (18 Ja

Regulatory Recon: FDA Posts New Agent in Singapore, CDC Issues Travel Advisory for Zika Virus (18 January 2016)

Posted 18 January 2016 | By Michael Mezher 

Regulatory Recon: FDA Posts New Agent in Singapore, CDC Issues Travel Advisory for Zika Virus (18 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

  • CDC Issues Warning on Zika Virus ( WSJ-$) ( Reuters) ( NYTimes) ( CDC)
  • FDA Posts OCI Agent In Singapore, But Other Foreign Offices Close ( Pink Sheet-$)
  • House Demands More Info On FDA Overseas Operations ( Pink Sheet-$)
  • FDA Details Cybersecurity Steps For Approved Med. Devices ( Law360-$) ( Reuters) ( Focus)

In Focus: International

  • Tanzania bans Lincoln Pharma's bacteria-fighting injection ( Economic Times)
  • Man Dies in France After Painkiller Drug Trial ( NYTimes) ( Focus)
  • More than 100 people quarantined after Sierra Leone Ebola death ( Reuters)
  • Partnership to improve prevention of women's cancers and quality of cancer registries in LAC reaches 1 year milestone ( IFPMA)

Sponsored Content: Gartner Research: Modernizing Enterprise Content Management

US: Pharmaceuticals and Biotechnology

  • The Big Debate: The 21st Century Cures Act ( PharmaLetter-$)
  • If Probuphine Is Approved, How Widely Would It Be Used? ( Pink Sheet-$)
  • Opioid Addiction Treatment Trials Could Be Tougher After Probuphine Review ( Pink Sheet-$)
  • FDA Fixed Combination and Co-packaging Proposed Rule ( Policy and Medicine)
  • Patent Expirations Of Crestor And Zetia And The Impact On Other Cholesterol Drugs ( Forbes)
  • Deal-making will offset drug development costs in 2016, says analyst ( Outsourcing-Pharma)
  • Companies Aim to Make Drugs from Bacteria That Live in the Gut ( MIT Technology Review)
  • Drug shortages in U.S. emergency rooms on the rise ( Reuters)
  • NIH Resumes Indian Trials, Will Others Follow? ( SCRIP-$)
  • Abbott's Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance ( FDA)
  • 'Lightning drug' to advance personalized medicine ( In-Pharma Technologist)
  • User Fee Extensions Are Key To CDER's First Cycle Review Success ( Pink Sheet-$)

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

  • FDA Accepts Priority Review sNDA For Eisai's Anticancer Agent Lenvatinib Seeking Approval For Renal Cell Carcinoma ( Press)
  • FDA approves two new indications for Cosentyx ( PharmaLetter-$) ( Press)
  • Alkermes Readies Depression NDA For ALKS 5461 ( SCRIP-$)
  • Strategia Therapeutics Initiates a Phase 1 Clinical Trial of the Radioimmunotherapeutic "FF-21101" For FUJIFILM in Patients with Advanced Cancers ( Press)
  • Researchers to Present New Data at ENDO 2016 Advancing the Understanding of Strensiq (asfotase alfa) in Infants, Children and Adult Patients with Hypophosphatasia ( Press)
  • Eleven Biotherapeutics Reports Phase 3 Data on Isunakinra (EBI-005) in Allergic Conjunctivitis ( Press)
  • Mesoblast/Teva May Have Shorter Path To Market In Chronic Heart Failure ( Pink Sheet-$)

US: Medical Devices

  • US FDA Hits User-Fee-Era Record For 'Novel' Devices ( SCRIP-$)
  • Some Come To Bury The Stethoscope, Some To Praise It ( CardioBrief)
  • Company to recall, redesign medical scope linked to 'superbug' outbreaks ( Washington Post)
  • Could UDI Have Prevented Infectious Outbreak? ( MDDI)
  • Class 1 Recall: SPOTCHEM II Basic Panel Test Strips and Glucose Test Strips ( FDA 1, 2)
  • LifeWatch Receives FDA Clearance for its Mobile Cardiac Telemetry 1-Lead Patch ( Press)
  • Class 1 Recall: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy ( FDA)
  • NIST simulates fast, accurate DNA sequencing through graphene nanopore  ( Press)
  • NICO Announces Hemorrhagic Stroke Trial Lead By Emory University And Grady Memorial ( MDDI)

US: Assorted and Government

  • Oversight on Outbreak re: Government Accountability Office ( National Law Review)
  • Will Supreme Court Lift 'IPR Pressure' Off Biopharma?  ( SCRIP-$)
  • Investigation faults U.S. Army lab's leaders over mistaken anthrax shipments ( Reuters)
  • Amgen's Humira Patent Challenge May Move To Court After PTO Board Declines Review ( Pink Sheet-$)
  • Merck agrees to pay $830 million to settle Vioxx securities lawsuit ( Reuters)
  • FDA Releases Draft Guidance for Modified Release Veterinary Parenteral Dosage Forms ( FDA)
  • MSD sues German Merck for using name in US ( Pharmafile)
  • The New One-Two Is Back ( Drug and Device Law)

Upcoming Meetings and Events              

Europe

  • MHRA statement on clinical trial in France ( MHRA)
  • Germany's Merck prevails in UK court over who can be called Merck ( PharmaLetter-$)
  • Russian pharmaceutical market may grow by 8% in 2016 ( PharmaLetter-$)
  • Imricor Medical Systems Receives CE Mark For MR Compatible Advantage-MR EP Recorder And Stimulator System ( MedDeviceOnline)

India

  • Government looks to cap trading margin on drugs at 35% ( Economic Times)
  • CDSCO relaxes norms on NOC for pharma exports to developed countries ( PharmaBiz)
  • Desi generics firms pave way for cheaper hepatitis C drug ( Economic Times)
  • Aurobindo Pharma gets USFDA nod for two generic drugs ( Economic Times)
  • Recommendations Of Latest Pharma Dept Task Force Similar To Previous Task Forces ( 24 Insight)
  • India One Step Closer To Dengue Vaccine – Sanofi On Track To Receive Phase 3 Clinical Trial Waiver ( 24 Insight)
  • ISCR sees need to engage pharma cos in pharmacovigilance programme to promote patient safety ( PharmaBiz)
  • Mobile app launched to help access free authentic data on patents for pharma industry ( PharmaBiz)

China

  • Continued Quality Push Among China's 2016 Regulatory Trends To Watch ( Tan Sheet-$)
  • China outlines drug complaint process to facilitate 'social cohabitation' ( FiercePharmaAsia)

Australia

  • Medical Devices Safety Update, Volume 4, Number 1, January 2016 ( TGA)

Other International

  • Green Cross's HCC Immunotherapy Set For Phase II ( PharmAsiaNews-$)

General Health and Other Interesting Articles

  • The Problem With The New Breast Cancer Screening Recommendations ( Forbes)
  • Dengue Fever – Hawaii Island Outbreak ( Hawaii.gov)

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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