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European Medicines Agency accepts submission of GSK's Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer prnasia
February 29, 2020
GlaxoSmithKline plc announced that the European Medicines Agency (EMA) has validated the company's Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to
QBiotics receives first registration for tigilanol tiglate with European Medicines Agency approval of Stelfonta(R) prnasia
January 20, 2020
Australian life sciences company, QBiotics Group Limited (QBiotics) is today announcing the first registration for its small molecule, tigilanol tiglate, with the European Medicines Agency (EMA) approval of STELFONTA as an oncology veterinary pharmaceutic
Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma firstwordpharma
January 09, 2019
"The MAA submission for selinexor is an important milestone for Karyopharm and the CHMP's granting of accelerated assessment further underscores the urgent need to improve outcomes for patients with highly refractory multiple myeloma," said Sharon Shacham
Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma firstwordpharma
January 09, 2019
"The MAA submission for selinexor is an important milestone for Karyopharm and the CHMP's granting of accelerated assessment further underscores the urgent need to improve outcomes for patients with highly refractory multiple myeloma," said Sharon Shacham
French inspectors find issues at Indian plant cited earlier by Italy fiercepharma
January 03, 2019
French inspectors found a lot they didn’t like about an Indian manufacturer when they inspected its operation for consideration of approving its ambroxol hydrochloride API.
IONIS-HTT Rx Granted PRIME Designation by the European Medicines Agency americanpharmaceuticalreview
August 06, 2018
Ionis announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to IONIS-HTTRx (also known as RG6042) for the treatment of people with Huntington's disease (HD). IONIS-HTTRx is the first drug to demonstrate reduction
New study offers detailed insights on biosimilars, follow-on biologics market pharmaasia
August 25, 2017
Biosimilar market is expected to gain prominence due to leading biologic drugs expected to lose exclusivity over the next seven years.
European Medicines Agency prepares for Brexit expressbpd
August 03, 2017
Develops business continuity plan to handle workload implications and reallocate resources to maintain its priority activities
Ireland reiterates bid to host the European Medicines Agency post-Brexit europeanpharmaceuticalreview
May 10, 2017
Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past week.