Tag: EMA

EMA Staff Reduced Following Departure from London

Following its Brexit-related departure from London, the European Medicines Agency’s (EMA) staff has been reduced from 897 staffers to 775, EMA said in an update from a board meeting in its new home in...

EMA Launched Pilot Programme on Cooperation in Sterile Medicines Production Inspections

sterile-manufacturing
EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative...

Intercept Pharma Submitted Application to EMA for Obeticholic Acid

Intercept Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that ...

ViiV Submitted Request to FDA and EMA for Dispersible Formulation of Dolutegravir

viiv healthcare
ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced it has made regulatory submissions to both the ...

EMA Recommended for Approval Five New Medicines

EMA
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting. The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) fo...

EMA Predicts Pharmacovigilance Contours in 2030

Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcar...

Results of EMA CVMP 3-5 December 2019 Meeting

EMA
CVMP adopts an updated advice on the categorisation of antibiotics in the European Union, and recommendations on the use of live attenuated PRRSV vaccines CVMP opinions on veterinary medicinal produ...

FDA and EMA Granted Orphan Drug Designation to Zotiraciclib

The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma. Zotiraciclib has been granted Orphan Drug...

EMA Agreed to Review Marketing Application for Amarin’s Vascepa

The European Medicines Agency (EMA) has agreed to review its marketing application for Amarin’s cardiovascular (CV) drug, Vascepa (icosapent ethyl). The regulatory organisation says that it is expe...

Bayer Submitted Application to EMA to Extend Xarelto Marketing Authorization

Bayer has submitted an application to the European Medicines Agency (EMA) to extend the Xarelto marketing authorization, making it available for children up to 17 years old with confirmed VTE, includi...

New Building Handed Over to EMA by Dutch Authorities

The Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s Executive Director, signed the lease agreement and thanke...

EMA Recommended Seven New Medicines for Approval

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its November 2019 meeting. The Committee recommended granting a marketing authorisation for Isturisa* (osilodrosta...

EMA Announced that Xeljanz Could Increase Risks of Blood Clots

EMA has concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. As a result, the Agency is recommending ...

EMA Issued Guideline on New Urate-Lowering Therapies

The European Medicines Agency (EMA) issued a guideline setting its expectations for the clinical development of new urate-lowering therapies (ULT) and anti-inflammatory drugs to treat gout. The 14-...

Access to Highly Innovative Therapies Can be Broadened by Regulators’ Advice

ema
Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable...

CVMP Recommended Two New Veterinary Medicines for MUMS/Limited Markets

ema
The Committee adopted by majority a positive opinion for an initial marketing authorisation application for Stelfonta (tigilanol tiglate), from QBiotics Netherlands B.V., a new product for the treatme...