European Medicines Agency (EMA)
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482 articles with European Medicines Agency (EMA)
Massachusetts in general and Boston, specifically Cambridge, is one of the two largest centers in the U.S. for biotech startups and life science companies (the other being the San Francisco Bay Area). Here’s a look at 13 Massachusetts life science companies that are showing both gains and losses—...
Four months after acquiring GlaxoSmithKline’s rare disease gene therapy portfolio, U.K.-based Orchard Therapeutics secured $150 million in an oversubscribed Series C funding round. The funds will be used to advance three late-stage programs that it gained from the deal with GSK.
China is the largest supplier of active pharmaceutical ingredients (API) in the world, supplying 40 percent of APIs to global pharma companies. And a recent series of scandals and issues related to drug manufacturing in China has highlighted how many problems this could cause the global drug supp...
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
AstraZeneca and Merck announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).
A Minnesota woman, Denise Miley, is suing Bristol-Myers Squibb and Otsuka Pharmaeutical, alleging that their Abilify (aripiprazole) for depression and anxiety, caused a gambling impulse. Her suit isn’t the only one.
IONIS-HTT Rx (RG6042) Granted PRIME Designation by the European Medicines Agency for the Treatment of People with Huntington's Disease
IONIS-HTT Rx is the first and only drug to demonstrate reduction of mutant huntingtin protein, the underlying cause of Huntington's disease, in patients
As Britain’s “Brexit” from the European Union moves closer and closer, the European Medicines Agency (EMA), the equivalent to the U.S. Food and Drug Administration (FDA), temporary halted some of its activities in preparation.
Clovis Oncology Receives EMA Validation for its Application for a New Indication for Rubraca®▼ (rucaparib) as Maintenance Treatment for Women with Recurrent Ovarian Cancer
The filing is based on positive phase 3 ARIEL3 clinical trial data in which rucaparib significantly improved progression free survival (PFS) compared to placebo in all primary efficacy ovarian cancer patient populations
Ultragenyx Announces Positive CHMP Opinion for Mepsevii™ (vestronidase alfa) For the Treatment of Mucopolysaccharidosis VII
ltragenyx Pharmaceutical Inc.(NASDAQ:RARE) today announced that the Committee for Medicinal Products for Human Use(CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization under exceptional circumstances of Mepsevii™ (vestronidase alfa) for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
Vyxeos™ Receives Positive CHMP Opinion for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia
Jazz Pharmaceuticals plc today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation of Vyxeos™ 44 mg/100 mg powder for concentrate for solution for infusion for the treatment...
ViiV Healthcare, established in November 2009 by GlaxoSmithKline, Pfizer and Shiongi, reported positive results from its Phase III GEMINI-1 and -2 clinical trials.
Portola Pharmaceuticals’ chief executive officer, William Lis, plans to retire as both chief executive and board member.
Clovis Oncology Submits Application to EMA to Expand Use of Rubraca®▼ (rucaparib) to Include Maintenance Treatment for Women with Recurrent Ovarian Cancer
Clovis Oncology, Inc. announced the submission of a regulatory application to the European Medicines Agency (EMA), as part of a type II variation seeking to expand the marketing authorization for Rubraca (rucaparib).
European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer (NSCLC)
Bristol-Myers Squibb Company announced that the European Medicines Agency (EMA) validated a type II variation application for the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for treatment in adult patients with first-line metastatic non-small cell lung cancer (NSCLC).
European Medicines Agency (EMA) Accepts BioMarin's Marketing Application for Pegvaliase MAA for Treatment of Phenylketonuria (PKU)
BioMarin Pharmaceutical Inc. announced that the European Medicines Agency (EMA) has accepted BioMarin's submission of a Marketing Authorization Application (MAA) for pegvaliase,
Fexinidazole would be first all-oral treatment* under investigation for both first and second stages of sleeping sickness.
European Medicines Agency Issues Orphan Drug Designation Positive Opinion for Omeros’ OMS721 in the Treatment of IgA Nephropathy
Omeros Corporation announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion on Omeros’ application for orphan drug designation of OMS721 in the treatment of primary Immunoglobulin A nephropathy (IgAN).
Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017.
ChemoCentryx: Avacopan Conditional Marketing Authorization Application Accepted for Regulatory Review by European Medicines Agency
Under the terms of its kidney health alliance with VFMCRP, ChemoCentryx will receive a milestone payment triggered by this validation of the avacopan CMA application by the EMA.