Regulatory Focus™ > News Articles > Regulatory Recon: EMA Recommends First Malaria Vaccine for Use Outside the EU (24 July 2015)

Regulatory Recon: EMA Recommends First Malaria Vaccine for Use Outside the EU (24 July 2015)

Posted 24 July 2015 | By Michael Mezher 

Regulatory Recon: EMA Recommends First Malaria Vaccine for Use Outside the EU (24 July 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 and @RAPSorg on Twitter.

In Focus: US

  • Industry Committed to Responsible Clinical Trial Data Sharing (The Catalyst)
  • FDA Limits Duration and Usage of Samsca (tolvaptan) (FDA)
  • FDA Discourages Sunesis From Submitting NDA (BioCentury) (Reuters) (SCRIP-$)
  • CDER Names Goldsmith Associate Director for Rare Diseases (BioSpectrum)
  • FDA Approves Diagnostic Test to Differentiate Between Types of HIV (FDA)
  • Bard Hit With FDA Warning Letter Affecting its Vena Cava Filters (FierceMedicalDevices)
  • Lawmakers add to FDA’s To-Do List in 2016 Appropriations Bills (FDA Law Blog)
  • Costly to Treat, Hepatitis C Gains Quietly in US (NYTimes)

In Focus: International                

  • EMA Recommends First Malaria Vaccine for Use Outside the EU (EMA) (Reuters) (BioSpectrum) (WSJ-$) (SCRIP-$)
  • EMA Recommends Ten New Medicines for Authorisation (EMA)
  • French Industry Kicked Off Key Government Committee (SCRIP-$)
  • Sanofi's Big New Cholesterol Drug Wins European Green Light (Reuters)
  • QR Codes in Labelling/Package Leaflet of Centrally Authorised Medicines (EMA)
  • Government Considering Compulsory Licence for Anti-Cancer Drug (Economic Times)
  • Trans-Pacific Partnership and Global Health Concerns (PharmaLetter-$)
  • South African Authorities Publish Additional Draft Regulations for Medical Devices (MassDevice)

US: Pharmaceuticals and Biotechnology

  • Industry Committed to Responsible Clinical Trial Data Sharing (The Catalyst)
  • FDA limits duration and usage of Samsca (tolvaptan) (FDA)
  • FDA discourages Sunesis from submitting NDA (BioCentury) (Reuters) (SCRIP-$)
  • PhRMA Countering PCSK9 Cost Concerns Ahead Of Launch (Pink Sheet-$)

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

  • Novartis: Tafinlar, Mekinist Achieve EU, US Regulatory Milestones (Press)
  • Janssen submits sNDA for Olysio (simeprevir) in combination with sofosbuvir (Press)
  • FDA grants "Fast Track" to Omeros' Complement Inhibitor OMS721 for aHUS (Press)
  • Genentech moves crenezumab into Phase III for AD (BioCentury)
  • Amgen Submits sNDA for Kyprolis in Relapsed Multiple Myeloma (Press)
  • Orphan Drug Designation Granted to XOMA 358 (Press)
  • Phase 3 Development Strategy for a Novel Glaucoma Treatment (Pharmaceutical Processing)
  • FDA Accepts Ready-to-Use Bivalirudin NDA for Filing (MPR)

US: Pharmaceuticals and Biotechnology: General

  • Group Calls For Classification Clarity Before Clinical-Decision Support Guidance (Gray Sheet-$)
  • CDER names Goldsmith associate director for rare diseases (BioSpectrum)
  • Coalition launches to protect access to OTC pain meds (DSN)
  • Assessing drug safety in human tissues — what are the barriers? (Nature-$)

US: Medical Devices

  • FDA approves diagnostic test to differentiate between types of HIV infection (FDA)
  • Bard hit with FDA warning letter affecting its vena cava filters (FierceMedicalDevices)
  • Alphatec reveals FDA warning letter (MassDevice)
  • Researchers develop first genetic test to predict tumor sensitivity to radiation therapy (MNT)
  • Miramar wins FDA nod for underarm hair reducer (MassDevice)
  • Medrobotics wins FDA 510(k) for transoral surgery device (MassDevice)
  • Medrobitics’ Flex Robotic Transoral Surgical System FDA Cleared (medGadget)
  • Diagnostic test developed for enterovirus D68 (MNT)
  • Sperm-counting iPad accessory for livestock to seek FDA approval for human use (FierceMedicalDevices)

US: Assorted and Government

  • DOD official: 'Massive institutional failure' led to anthrax mishap (SCRIP-$)
  • Lawmakers Add to FDA’s To-Do List in 2016 Appropriations Bills (FDA Law Blog)
  • Inside the Implied Conflict Preemption Box (Drug and Device Law)
  • Pharmacy owners cannot cite religion to deny medicine: US appeals court (Reuters)
  • Little Sisters of the Poor appeal birth control ruling to Supreme Court (Modern Healthcare)
  • GAO Report Finds Seven Federal Agencies Invested $2.89 Billion in Regenerative Medicine Research from 2012-2014 (SCOUT) (GAO)
  • US District Court rules in favor of Neuralstem in patent infringement case (PharmaLetter-$)

Upcoming Meetings and Events

Europe

  • Ten new medicines recommended for authorisation in the EU (EMA)
  • First malaria vaccine receives positive scientific opinion from EMA (EMA) (Reuters) (BioSpectrum) (WSJ-$) (SCRIP-$)
  • French industry kicked off key government committee (SCRIP-$)
  • Sanofi's big new cholesterol drug wins European green light (Reuters)
  • Calls for Expression of Interest: EMA Management Board, PRAC, CAT (EC)
  • Q&A: Positions on Specific Questions Addressed to the Pharmacokinetics Working Party (EMA)
  • Expert Review Concludes Alteplase is Safe and Effective Within Existing Treatment Guidelines (MHRA) (MHRA) (Press)
  • Spate of EMA Guidelines Released (EMA) (EMA) (EMA)
  • Iceland Adopts EFPIA Disclosure Code (Policy and Medicine)
  • Regulator asks people to check for faulty needles (MHRA)
  • QR codes in the labelling and package leaflet of centrally authorised medicinal products (EMA)
  • Merck: EMA Accepts Marketing Authorization Application for Investigational HCV Treatment (Press)
  • Novartis: Tafinlar, Mekinist Achieve EU, US Regulatory Milestones (Press)
  • NICE recommends secukinumab, Vargatef (nintedanib) and Eylea (MNT) (MNT) (MNT)
  • Mauna Kea wins CE Mark for Cellvizio 800 (MassDevice)

India

  • Government Considering Proposal for Compulsory Licence to Anti-Cancer Drug (Economic Times)
  • India's top court says NGO can petition government on essential drugs (Reuters)
  • India rejects Swiss drug maker Roche Patent claims on Valcyte again (Economic Times)
  • Major hurdles 'cleared' for clinical trials in India (Economic Times)
  • India's drug and CRO manufacturing travails gather pace as New Delhi calls on diplomats to help (FiercePharmaAsia)

China

  • True Diagnostics' thyroid kit receives CFDA nod (BioSpectrum)
  • CFDA Surprises Industry With Clinical Data Self-Audit Notice (PharmAsiaNews)

Japan

Canada

  • Cardiome submits sNDS for Aggrastat to Health Canada (PharmaBiz)

Other International

  • Trans-Pacific Partnership and Global Health Concerns (PharmaLetter-$)
  • South African authorities publish additional draft regulations for medical devices (MassDevice)
  • WHO calls for urgent action to curb hepatitis (WHO)

General Health and Interesting Articles

  • These Superhumans Are Real and Their DNA Could Be Worth Billions (Bloomberg)
  • Experts Urge Transplantation of Hepatitis C-Infected Kidneys in Some Non-Infected Patients (ICT)
  • Costly to Treat, Hepatitis C Gains Quietly in US (NYTimes)
  • Inverting the clinical trial/physician relationship: The future (and data) is in the practice (MassDevice)
  • Attacking cancer: are therapeutic vaccines on the verge of fulfilling their potential? (PJ Online-$)

Regulatory Reconnaissance #603– 24 July 2015

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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