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European Pharmaceutical Review

Children in the world’s poorest countries could receive vaccination against rotavirus diarrhoeal disease

GSK has announced that it has made a new offer to supply its rotavirus vaccine, Rotarix™, to the GAVI Alliance at $2.50 per dose, a small fraction of developed world prices. This announcement is part of the company’s efforts to increase access to its medicines and vaccines in the world’s poorest countries. It is estimated that more than half a million children die of rotavirus gastroenteritis each year – the equivalent of a child a minute worldwide – and it is responsible for the hospitalisation of millions more....

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More pharmaceutical & life science news:

Merck commends GAVI Alliance on continued efforts to improve access
Merck commends the GAVI Alliance and donor organisations, governments and partners for their commitment to protecting the lives of children from vaccine preventable diseases and for the continued commitments announced today...

Biogen Idec receives approval in the European Union for AVONEX(R) PEN(TM)
Biogen Idec has announced that the European Commission has granted approval to AVONEX PEN for patients with relapsing multiple sclerosis (MS) and patients who have had a single demyelinating event...

New data in breast and ovarian cancer presented at ASCO support continued development of Iniparib
Sanofi has announced new data for iniparib (BSI-201), an investigational agent, in metastatic triple-negative breast cancer (mTNBC), platinum-sensitive and platinum-resistant recurrent ovarian cancer...

Merck and ARIAD announce presentation of results of Phase III SUCCEED trial
Merck and ARIAD Pharmaceuticals, Inc. have announced the presentation of detailed results from the Phase III SUCCEED clinical trial...

Novartis gains European Commission approval for Lucentis®
The European Commission has granted Novartis a new indication for Lucentis® (ranibizumab) to treat patients with visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO and central RVO)...

ZALTRAP™ (aflibercept) significantly improved survival in previously treated metastatic colorectal cancer patients
Data showing that the investigational agent ZALTRAP™ (aflibercept), also known as VEGF Trap, significantly improved survival in previously treated metastatic colorectal cancer patients will be presented at the ESMO World Congress on Gastrointestinal Cancer on June 25, 2011...

Patients with deadly form of lung cancer lived longer without disease worsening
Eli Lilly and Company has announced that PARAMOUNT, its Phase III study evaluating ALIMTA® (pemetrexed for injection) in the continuation maintenance setting, met its primary endpoint of progression-free survival, or the time a patient is alive without their disease worsening, for patients with a specific type of lung cancer called advanced nonsquamous non-small cell lung cancer (NSCLC)...

Second Phase 3 Study of YERVOY™ (ipilimumab) in Metastatic Melanoma Meets Primary Endpoint of Overall Survival
Bristol-Myers Squibb Company has announced results from a second Phase 3 randomized, double blind study demonstrating that YERVOY™ (ipilimumab) prolonged the lives of patients with metastatic melanoma...

Roche announces vemurafenib improved survival in people with metastatic melanoma who have BRAF V600 mutations
Roche has announced that a Phase III study (BRIM3) showed vemurafenib (RG7204, PLX4032) significantly improved overall survival in people with previously untreated BRAF V600 mutation...

Roche announces data to show Avastin based regimen halved the risk of disease getting worse in women with recurrent ovarian cancer
Roche has announced results from OCEANS, a phase III study evaluating Avastin (bevacizumab) in combination with chemotherapy (gemcitabine and carboplatin) followed by the continued use of Avastin alone in women with previously treated (recurrent) platinum-sensitive ovarian cancer...

Late-breaking ASCO data demonstrate circulating tumor cells as potential biomarker for metastatic prostate cancer clinical trials
Data presented at the 47th American Society of Clinical Oncology (ASCO) annual meeting demonstrate the potential of circulating tumor cells (CTC) as a biomarker for metastatic prostate cancer clinical trials...

12th Annual Drug Discovery Leaders Summit 2011
8 - 9 June 2011, Le Montreux Palace, Montreux, Switzerland

TATAA Biocenter qPCR symposium
13 - 17 June 2011, Prague, Czech Republic

ISSCR 9th Annual Meeting
15 - 18 June 2011, Toronto, Canada

DIA 2011
19 - 23 June 2011, Chicago, Illinois


Global Pharma Manufacturing Summit 2011

20 - 21 June 2011, New Jersey, USA


Genotoxic Impurities
28 - 29 June 2011, Berlin, Germany

Next-Gen Sequencing Europe
30 June - 1 July 2011, Hamburg, Germany

European Lab Automation Congress 2011
30 June - 1 July 2011, Hamburg, Germany

FREE WEBINAR

Looking beyond implementation to drive business value from the FDA Process Validation Guidance
Sponsored by CAMO Software

Date: Wednesday 22nd June
Time: 15:00 GMT (16:00 CET / 10:00 EDT)
Length: 1 Hour

Realize significant cost savings and build lasting competitive advantage through process improvement and knowledge transfer.
Manufacturers approaching the FDA's new industry guidance for Process Validation from a strategic perspective have the opportunity to build competitive advantage throughout their entire value chain. Combining strategic insights with practical advice, this webinar will highlight opportunities to generate significant returns.

Learnings:

  • Reasons for issuing this guidance and how it differs from previous guidance
  • Practical implications for manufacturers
  • Creating value and building a strategic advantage
  • Worked example calculation for a ‘typical’ manufacturer

Speakers:

  • Bruce Davis: Director of Global Consulting, formerly with AstraZeneca and past Chair of the ISPE Board of Directors
  • Brad Swarbrick: Vice President, CAMO Software and formerly with the Pfizer Global PAT Group.
     


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