Publication: European Pharmaceutical Review

First reported Apr 17 2014 - Updated Apr 18 2014 - 1 reports

Volasertib, Boehringer Ingelheim´s investigational treatment of acute myeloid leukaemia, is granted ‘orphan drug designation’ in the EU and the US

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) and the European Commission have granted volasertib* ‘orphan drug designation’ for the treatment of patients with acute myeloid leukaemia (AML).AML is an aggressive cancer ... [Publicerad European Pharmaceutical Review - Apr 17 2014]
First reported Apr 15 2014 - Updated Apr 16 2014 - 1 reports

Abbvie announces initiation of pivotal Phase III study of veliparib (abt-888) for patients with non-small cell lung cancer

AbbVie (NYSE: ABBV) announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), in patients with previously untreated locally advanced or metastatic squamous non-small ... [Publicerad European Pharmaceutical Review - Apr 15 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 1 reports

Gilson Europe interviewed at analytica 2014

Andrew Johnson, European Pharmaceutical Review speaks with Ronan Herry, Marketing Director, Gilson Europe at analytica 2 ... [Publicerad European Pharmaceutical Review - Apr 15 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

Announcement regarding merger between Sun Pharma and Daiichi Sankyo’s subsidiary Ranbaxy and resulting change in subsidiary

, pursuant to a merger transaction, whereby Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) has agreed with Sun Pharmaceutical Industries Ltd. (“Sun Pharma”) in favor of Sun Pharma’s acquisition of Ranbaxy Laboratories Limited (“Ranbaxy”), Daiichi ... [Publicerad European Pharmaceutical Review - Apr 11 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2014

The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review and started four new safety reviews at its April meeting.The PRAC has advised that the combined use of two medicines of different classes acting on the renin-angiotensin ... [Publicerad European Pharmaceutical Review - Apr 11 2014]
First reported Apr 09 2014 - Updated Apr 10 2014 - 1 reports

Supplemental New Drug Application for IMBRUVICA™ (ibrutinib) submitted to the U.S. FDA

, LLC (“Janssen”) today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE™ ... [Publicerad European Pharmaceutical Review - Apr 09 2014]
First reported Apr 08 2014 - Updated Apr 08 2014 - 1 reports

OncoEthix presents Phase I interim results for novel anticancer compound OTX015 at AACR 2014

OncoEthix, the Swiss-based specialist in oncology drug development, today announced that the interim results from its ongoing Phase I clinical trial of OTX015, in patients with hematologic malignancies, were presented at the annual American Association ... [Publicerad European Pharmaceutical Review - Apr 08 2014]
First reported Apr 07 2014 - Updated Apr 08 2014 - 1 reports

EMA and Australian regulator strengthen collaboration in the area of orphan medicines

the EMA’s Executive Director, Prof. Guido Rasi, and the National Manager of the Australian Therapeutic Goods AdministrationExternal link icon (TGA), Prof. John Skerritt, announced that the two regulators have agreed to share the full assessment reports ... [Publicerad European Pharmaceutical Review - Apr 07 2014]
First reported Apr 07 2014 - Updated Apr 07 2014 - 1 reports

Amgen provides update on Phase 3 study of talimogene laherparepvec in patients with metastatic melanoma

Amgen (NASDAQ: AMGN) today announced top-line results from the primary overall survival (OS) analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC ... [Publicerad European Pharmaceutical Review - Apr 07 2014]
First reported Apr 07 2014 - Updated Apr 07 2014 - 1 reports

Treatment with once-monthly Abilify Maintena® (aripiprazole) significantly reduces hospitalisation rates for patients with schizophrenia compared with daily oral antipsychotics

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Europe Ltd. (Otsuka) today announced results from the final analysis of a mirror-image study showing statistically significant reductions (p0.0001) in total psychiatric hospitalisation rates in patients ... [Publicerad European Pharmaceutical Review - Apr 07 2014]
First reported Apr 07 2014 - Updated Apr 07 2014 - 1 reports

Subpoena for Ranbaxy’s Toansa Plant

Attached is the statement of Ranbaxy Laboratories, a subsidiary of , Limited, which was issued on April 7th, 2014United States Attorney’s Office for the District of New Jersey has issued an administrative subpoena dated 13th March to Ranbaxy seeking information ... [Publicerad European Pharmaceutical Review - Apr 07 2014]
First reported Apr 04 2014 - Updated Apr 04 2014 - 1 reports

Merck receives 2014 ENERGY STAR Sustained Excellence Award from U.S. Environmental Protection Agency

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that it has received an ENERGY STAR 2014 Partner of the Year – Sustained Excellence Award from the U.S. Environmental Protection Agency (EPA) for its continued improvement ... [Publicerad European Pharmaceutical Review - Apr 04 2014]

More Content

All (36) | News (36) | Reports (0) | Blogs (0) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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Volasertib, Boehringer Ingelheim´s investigatio... [Publicerad European Pharmaceutical Review - Apr 17 2014]
Abbvie announces initiation of pivotal Phase II... [Publicerad European Pharmaceutical Review - Apr 15 2014]
Gilson Europe interviewed at analytica 2014 [Publicerad European Pharmaceutical Review - Apr 15 2014]
Meeting highlights from the Pharmacovigilance R... [Publicerad European Pharmaceutical Review - Apr 11 2014]
Announcement regarding merger between Sun Pharm... [Publicerad European Pharmaceutical Review - Apr 11 2014]
Supplemental New Drug Application for IMBRUVICA... [Publicerad European Pharmaceutical Review - Apr 09 2014]
OncoEthix presents Phase I interim results for ... [Publicerad European Pharmaceutical Review - Apr 08 2014]
EMA and Australian regulator strengthen collabo... [Publicerad European Pharmaceutical Review - Apr 07 2014]
Treatment with once-monthly Abilify Maintena® (... [Publicerad European Pharmaceutical Review - Apr 07 2014]
Subpoena for Ranbaxy’s Toansa Plant [Publicerad European Pharmaceutical Review - Apr 07 2014]
Amgen provides update on Phase 3 study of talim... [Publicerad European Pharmaceutical Review - Apr 07 2014]
Merck receives 2014 ENERGY STAR Sustained Excel... [Publicerad European Pharmaceutical Review - Apr 04 2014]
Daiichi Sankyo and UC San Francisco announce co... [Publicerad European Pharmaceutical Review - Apr 03 2014]
Shire submits INTUNIV® (guanfacine extended rel... [Publicerad European Pharmaceutical Review - Apr 01 2014]
Sanofi appoints Dr. Anne C. Beal to the newly c... [Publicerad European Pharmaceutical Review - Mar 31 2014]
Novartis to work with FDA on path forward for R... [Publicerad European Pharmaceutical Review - Mar 28 2014]
European Pharmaceutical Review interviews Freem... [Publicerad European Pharmaceutical Review - Mar 28 2014]
GSK receives European authorisation for once-we... [Publicerad European Pharmaceutical Review - Mar 26 2014]
European Pharmaceutical Review interviews Tecan... [Publicerad European Pharmaceutical Review - Mar 26 2014]
Daiichi Sankyo to facilitate new Drug Discovery... [Publicerad European Pharmaceutical Review - Mar 25 2014]
Daiichi Sankyo receives approval in Japan for m... [Publicerad European Pharmaceutical Review - Mar 24 2014]
Meeting highlights from the Committee for Medic... [Publicerad European Pharmaceutical Review - Mar 24 2014]
CMDh endorses recommendations to restrict the u... [Publicerad European Pharmaceutical Review - Mar 24 2014]
European Medicines Agency recommends authorisat... [Publicerad European Pharmaceutical Review - Mar 24 2014]
EMA recommends approval of a locally targeted t... [Publicerad European Pharmaceutical Review - Mar 21 2014]
Get the green light for weighing with new analy... [Publicerad European Pharmaceutical Review - Mar 21 2014]
Janssen investigational treatment for schizophr... [Publicerad European Pharmaceutical Review - Mar 20 2014]
Abbvie initiates new clinical trial to evaluate... [Publicerad European Pharmaceutical Review - Mar 20 2014]
Sanofi Pasteur allies with SK Chemical Co. of S... [Publicerad European Pharmaceutical Review - Mar 19 2014]
EMA publishes its work programme for 2014 [Publicerad European Pharmaceutical Review - Mar 19 2014]
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