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28 Sep 2017, 6:35 am
The survey indicates that for 65% of EMA staff, the new EMA location will be a determining factor in their decision-making whether to relocate or not. [read post]
2 Dec 2010, 9:50 pm
By James DeGiulio -- On November 23, the European Medicines Agency (EMA) published guidelines for biosimilar monoclonal antibodies (mAb). [read post]
30 Nov 2010, 8:51 pm
By James DeGiulio -- On November 23, the European Medicines Agency (EMA) finally published its guidelines for biosimilar monoclonal antibodies (mAb). [read post]
1 Mar 2012, 11:07 am
With the additional capacity of a second EMA approved facility, Shire will have the ability to significantly increase the global supply of VPRIV while also [...] [read post]
20 Nov 2017, 12:00 pm
Actually.So how did Amsterdam do in the EMA's relocation staff retention survey in September 2017? [read post]
27 Jan 2020, 2:00 pm
EMA’s safety committee [Pharmacovigilance Risk Assessment Committee (PRAC)] is currently reviewing data on skin cancer in patients using Picato. [read post]
22 Sep 2011, 12:00 pm
EMA Cites The Increased Risks Of Liver Injury, Lung Side Effects, And Cardiovascular Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) In late September 2011 the European Medicines Agency (EMA) recommended that the use of Sanofi's antiarrhythmic medication Multaq (dronedarone) be restricted to certain patients with paroxysmal or persistent atrial fibrillation. [read post]
22 Oct 2012, 12:40 pm
For some background on this decision by the European Medicines Agency (EMA), we look to this October 19, 2012 Fierce Pharma news report, "EMA committee shoots down Vivus diet pill": Vivus wasn't expecting a warm reception from European officials, and those expectations bore out. [read post]
7 Jun 2017, 7:17 am
The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017. [read post]
11 Sep 2020, 1:20 pm
In Lowe’s, the JCC excluded an EMA’s opinion on an issue over which the health care experts had not disagreed. [read post]
4 Nov 2019, 2:15 pm
Back in May 2019 there was an EMA press release about Xeljanz, "Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs", that previewed this EMA’s safety committee (PRAC) is recommending that doctors must not prescribe the 10 mg twice daily dose of Xeljanz (tofacitinib) in patients who are at high risk of blood clots in the lungs. [read post]
11 Feb 2022, 12:57 pm
” Now the issue of JAK inhibitors drug class safety is coming up in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, "EMA starts safety review of Janus kinase inhibitors for inflammatory disorders". [read post]
14 Nov 2016, 5:45 pm
EMA Policy 0070 provides for the proactive publication by the EMA of clinical data from clinical reports submitted to it. [read post]
European Drug Regulator EMA Suspends Use Of MRI Drugs Magnevist, Omniscan, And OptiMARK In July 2017
3 Aug 2017, 12:55 pm
To understand these divergent paths, we start with the timeline of events giving rise to the EMA's suspension of the MRI drugs Magnevist, Omniscan, and OptiMARK in July 2017. [read post]
26 Jul 2011, 9:48 pm
., and in March 2010, the European Medicines Agency (EMA) rejected Europe's first filed gene therapy application. [read post]
20 Nov 2022, 11:22 am
The EMA system is a roll of the dice for both sides. [read post]
28 Jun 2011, 9:56 am
EMA. [read post]
1 Jun 2017, 8:08 am
The EMA and FDA have also published a timeline to illustrate the various steps of the PSA Program. [read post]
22 Jun 2022, 1:40 pm
While reviewing a June 14, 2022, European Pharmaceutical Review (EPR) article about the most recent meeting of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), we learned about a new Xalkori drug safety issue arising out of some clinical trials involving pediatric patients treated with Xalkori. [read post]
24 Nov 2010, 12:41 pm
Judge Emas has been a Circuit Court Judge since 2001. [read post]
