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10 Apr 2019, 6:50 pm
In related news from elsewhere, Ema O’Connor of BuzzFeed News reports that “Ohio Has Once Again Passed A Bill To Ban Abortion After A Month And A Half; This Time The Governor Says He’ll Sign It. [read post]
23 Sep 2010, 1:38 pm
As DJN reports, the EMA says patients taking rosiglitazone shouldn’t stop on their own, but should make an appointment with a physician to discuss their options. [read post]
13 Jul 2011, 7:51 am
European Medicines Agency (EMA) - which is basically Europe's FDA - will decide this month whether the diabetes drug Actos should remain on the market or not due to a possible link to bladder cancer. [read post]
4 Oct 2010, 10:48 pm
By James DeGiulio -- As the Food and Drug Administration begins gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"), the European Medicines Agency (EMA) announced that it has finalized its requirements for biosimilar antibodies, and that these requirements will be made public in November. [read post]
6 Jun 2011, 11:03 am
EMA and Flores-Villar v. [read post]
7 Jul 2011, 12:55 pm
EMA, this was by no means an ordinary term. [read post]
4 Jun 2019, 12:41 pm
Prescribers should also consider other factors that may increase the risk for PE, including age, obesity, smoking, or immobilization, the EMA said in a news release. [read post]
8 Nov 2010, 4:32 am
As blog posters have repeatedly mentioned, your three finalists for the 3rd DCA are Judge Kevin Emas, Judge Ivan Fernandez and Ed Scales. [read post]
25 Sep 2013, 2:31 pm
From an August 1, 2013 Medscape news report, "FDA Sides With EMA on Incretin Diabetes Drugs": Lisa Kubaska, from the FDA's Center for Drug Evaluation and Research (CDER), told Medscape Medical Newstoday, the FDA "had conversations with EMA and was aware of their analyses regarding the potential pancreatic effects of GLP-1 based therapies. [read post]
31 Jan 2018, 8:05 am
The incident, which left Hawaii residents in a panic for 38 minutes thinking a ballistic missile was bound for their state, was initially blamed on bad software—HI-EMA said that an employee had accidentally selected the wrong choice in a menu of confusing choices. [read post]
18 Feb 2011, 4:11 am
associate Kevin Emas gets investitured (ed. note -- is that a word?) [read post]
16 Oct 2022, 10:02 pm
Devarsetty from Sandoz and Christine Berndt from STADA Arzneimittel AG will host, wherein ACI faculty will offer presentations on the following topics: • The Unitary Patent and Patent Court and strategies for biosimilars and originator biologics • The impact of anticipated EU regulatory change on Life Sciences companies • A comparison of global biosimilar regulation before the EMA and FDA • European Supplementary Protection Certificates and... [read post]
10 Jan 2017, 10:32 am
"Jeff Sessions Says Decision Allowing Abortion Deserves Respect And Will Be Followed; Despite calling the federal legalization of abortion 'one of the worst, colossally erroneous Supreme Court decision of all time,' Sessions said he would 'respect' it": Ema O'Connor of BuzzFeed News has this report. [read post]
11 Jul 2018, 4:38 am
Contents include:Cherie Blair, Ema Vidak-Gojkovic, & Marie-Anaïs Meudic-Role, The Medium Is the Message: Establishing a System of Business and Human Rights Through Contract Law and ArbitrationPaul Lefebvre & Dirk De Meulemeester, The New York Convention: An Autopsy of Its Structure and Modus OperandiTamás Szabados, EU Economic Sanctions in ArbitrationStepan Puchkov, Psycholawgy: What Dispute Resolution Practitioners Overlook? [read post]
18 Oct 2013, 9:05 pm
C5 faculty will offer presentations on the following topics: • Analysing the EMA's monoclonal antibody guidelines: How to get regulatory approval of your mAb; • Harmonising your biosimilar development programme to obtain regulatory approval in Europe and America; • Updating your chemistry, manufacturing & control (CMC) strategies in line with evolving global biosimilar regulations and current market trends; • Why prescribe? [read post]
5 Jun 2013, 12:52 pm
CHARLES THE GREAT WINS AT THE 3RD DCASpeaking of our favourite appellate court, Judge Emas wrote here for the court reversing the contempt conviction and six month sentence for the aptly named Emmanuel Charlemagne. [read post]
5 Jun 2012, 2:35 pm
In May 2012 we learned that the European Medicines Agency (EMA) wants the Pradaxa prescribing information, also called the package insert or label, revised to give clearer guidance to European doctors and patients about how they might reduce and manage the risk of serious bleeding events that have associated with this relatively new anticoagulant medicine from Boehringer. [read post]
5 Jun 2012, 2:35 pm
In May 2012 we learned that the European Medicines Agency (EMA) wants the Pradaxa prescribing information, also called the package insert or label, revised to give clearer guidance to European doctors and patients about how they might reduce and manage the risk of serious bleeding events that have associated with this relatively new anticoagulant medicine from Boehringer. [read post]
18 Sep 2010, 7:58 am
EMA. [read post]
24 Sep 2010, 11:06 am
The European Medicines Agency (EMA), recommended suspension of marketing authorizations for anti-diabetes medicines containing rosiglitazone. [read post]
