Regulatory Focus™ > News Articles > Regulatory Recon: FDA Rejects BioMarin DMD Drug, WHO Declares End of Ebola Epidemic (14 January 2016

Regulatory Recon: FDA Rejects BioMarin DMD Drug, WHO Declares End of Ebola Epidemic (14 January 2016)

Posted 14 January 2016 | By Michael Mezher 

Regulatory Recon: FDA Rejects BioMarin DMD Drug, WHO Declares End of Ebola Epidemic (14 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 rejects BioMarin's DMD drug (Reuters) (WSJ-$)
  • FDA Ruling On Gepirone Efficacy Data Delayed By One Month (Pink Sheet-$)
  • Progress and Collaboration on Clinical Trials (FDA Voice)
  • Senate Version of 21st Century Cures Act Delayed (Morning Consult)
  • User Facility MDR Inspections: Emerging Signal of an FDA Compliance Concern? (FDA Law Blog)
  • Authentic Drugs Tagged with Plant DNA Could Help Snare Fake Meds (Scientific American)

In Focus: International

  • Turkey Plans Incentives For Local Pharmaceutical Manufacture (PharmAsiaNews-$)
  • MHRA To Support UK Transitional QPs' Continuing Role Under EU Clinical Trials Regulation (SCRIP-$)
  • Ebola epidemic ended in West Africa but flare ups possible (Reuters) (WHO)
  • Scientist argues her case for UK license to "edit" human embryos (Reuters)
  • Preparing for pandemics could cost less than $1 each a year, review says (Reuters)

Sponsored Content: The Regulatory Affairs Landscape has Evolved. Will You?

US: Pharmaceuticals and Biotechnology

  • 'Moonshot' to Cure Cancer, to Be Led by Biden, Relies on Outmoded View of Disease (NYTimes)
  • Doctors Respond To Obama's Ambitious Moonshot To Cure Cancer (NPR)
  • CDC Opioid Guidelines Get More Than 4000 Comments to Docket (Regulations.gov)
  • EPIRUS Biopharmaceuticals: What Biosimilars Can Learn From The Generics Market (Bioprocess Online)
  • FDA Plans Pilot Project on Clinical Outcome Assessments (Focus)
  • Better data can encourage industry to trial generics for new indications (In-PharmaTechnologist)
  • Health and Human Services Regulatory Agenda for 2016 (Policy and Medicine)
  • Long-Term Opioid Use Linked To Increased Risk of Depression (Forbes)
  • Pfizer says its CAR T cancer therapy could outshine rivals (Reuters)
  • Hospital vaccine mishap affects hundreds of children (CBS)
  • Duchenne pioneer says FDA rejection of Sarepta's drug 'would be a travesty (Boston Business Journal)
  • Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry (FDA)
  • Morphine for back pain tied to rapid changes in brain (Reuters)
  • Paroxetine in early pregnancy once again linked to birth defects (Reuters)

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

  • FDA Approves Waiver of NDA Filing Fee for Elite Pharmaceuticals (Press)
  • Vyome Bio's acne drug VB 1953 NDA Accepted by FDA (Economic Times)
  • Astellas Pharma Europe: Lancet Oncology Publishes Results from the Phase 2 TERRAIN Trial of Enzalutamide Compared to Bicalutamide in Metastatic Castration-Resistant Prostate Cancer (Press)

US: Medical Devices

  • Report Says FDA, Device Makers Failed In Superbug Outbreak (Law360-$) (Washington Post) (WSJ-$) (Focus)
  • Q&A: FDA's Gutierrez, Mansfield Discuss Regulatory Efforts in 2015, Set 2016 Expectations (GenomeWeb-$)
  • FDA warns ARB Medical on polymeric surgical meshes (MassDevice)
  • FDA Continues Next-Gen Sequencing Push With Two More Meetings (Gray Sheet-$)
  • Medgadget @ CES 2016: Samsung Shows Off S-Patch Wearable Featuring Its Bio-Processor Chip (medGadget)
  • FDA Clears Siemens' New High-volume Coagulation Analyzer (Press)
  • Pulmonx Completes Enrollment of Randomized, Prospective, Multi-Center Study in New Patient Population (Press)
  • Neurometrix gets FDA clearance for smartphone-controlled Quell device (mobihealthnews)

US: Assorted and Government

  • Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around? (Drug and Device Law)
  • The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part I, II)
  • STAT and WSJ Stumble On Drug Pricing Reporting (DrugWonks)
  • Economists on FDA Reciprocity (Marginal Revolution)
  • CA Drug Pricing Bill Can't Pass Committee (CaliforniaHealthline)
  • What You May Not Know (But Should) About Voluntarily Surrendering Your DEA Registration (National Law Review)
  • PhRMA Fears 'Potentially Limitless' State Suits After Risperdal Case (Pink Sheet-$)
  • Appeals court hands J&J's Ethicon a loss in stapler patent spat with Covidien (MassDevice)
  • How Much Does Congress Care About Drug Prices? Less Than It Should (HealthAffairsBlog)
  • "Frank" Talk On Drug Pricing: HHS Official Sees Value-Based Pricing As Area Of Common Interest (RPM Report-$)
  • Gilead Can't Touch Attorney's Work In Merck Patent Suit (Law360-$)
  • J&J Moves Suit Over Children's Motrin Back To Federal Court (Law360-$)
  • PTAB Says It Wrongly Denied AIA Review In Pacemaker Case (Law360-$)
  • Congress' Conflicting Approach Toward Medical Marijuana (Law360-$)

Upcoming Meetings and Events              

  • RAPS' FDA Advisory Committee Meeting Tracker
  • Workshop on the implementation of ISO standard for individual case safety reports – 4 March 2016 (EMA)
  • Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - January 21, 2016 (FDA)

Europe

  • NICE updates guideline to help eliminate TB from England (PharmaTimes)
  • Update to Guideline on good pharmacovigilance practices (GVP) (EMA)
  • Access to EudraVigilance Data: EMA Will Review Some Academic Uses (Focus)
  • List of centrally authorised products requiring a notification of a change for update of annexes (EMA)

India

  • FDA approves Aurobindo's Aygestin generic (DSN)
  • British drug maker AstraZeneca may launch innovative drugs in India (Economic Times)
  • Pfizer's Upcoming Indian Patent Hearing For PCSK9 Inhibitor (24 Insight)
  • Pharmacogenomics to address ADRs specific to vulnerable populations under PvPI (PharmaBiz)
  • Centre extends barcode implementation for export of drugs & maintaining parent-child relationship in packaging (PharmaBiz)
  • Pharma sector can touch Rs 4 lakh crore by 2020: Ananth Kumar (Economic Times)

Canada

  • Drug Licensees Subject To Federal Price Regulation In Canada (Law360-$)
  • GE teams with Canadian Gov to set up C$40m cell therapy tech centre (BioPharma-Reporter)

Other International

  • Interview: The Biosimilar Brain - Celltrion's Dr. Stanley Hong (PharmAsiaNews-$)
  • 2016 Preview: South Korea - License Deals, Biosimilar Approvals In Store (PharmAsiaNews-$)
  • Spike in dengue cases expected in Thailand in 2016, expert says (Reuters)
  • Ukrainian health official says 25 people killed by swine flu (Reuters)
  • Armenia says 10 people died from H1N1 swine flu (Reuters)
  • Hens culled after bird flu strain found on Scottish farm (Reuters)
  • Bird flu outbreak found outside French restriction zone (Reuters)

General Health and Other Interesting Articles

  • Stinging Report On Pandemics Makes Louis Pasteur Look Like A Prophet (NPR)
  • Hemophilia Patient or Drug Seller? Dual Role Creates Ethical Quandary (NYTimes)
  • CDC May Warn Pregnant Women Against Travel to Countries With Zika Virus (NYTimes)
  • Infants can get into unsecured medicines (Reuters)

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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