Article Listing - Biotechnology

Is failure to adopt business process management putting the pharma industry at risk?

21 May 2013

The dynamic pharmaceutical, biotech and life-science sectors are constantly evolving. With frequent mergers, acquisitions, competitive pressures and the need to meet stringent regulation, companies operating in this arena need to be able to analyze and streamline core business processes - as well as deliver corporate and regulatory governance to the highest standards, say Jeff Fraleigh, US senior vice president and Eileen Cairo, senior consultant at Casewise, in a contributed article for The Pharma Letter.

Pace of drug approvals to moderate for global pharma companies, says Fitch Ratings

21 May 2013

Global pharmaceutical novel drug approvals will moderate in 2013 due to the exceptional research success in 2012, according to a Fitch Ratings report.

Germany's G-BA issues final assessment for Cell Thera's Pixuvri

21 May 2013

USA-based Cell Therapeutics (Nasdaq: CTIC) says that Germany's Federal Joint Committee (G-BA) has issued its final benefit assessment report for Pixuvri (pixantrone), which is indicated as a monotherapy for the treatment of adult patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who have failed two or three prior lines of therapy.

Stallergenes and DBV Technologies partner on developing novel respiratory allergies treatments

20 May 2013

French biotech firms DBV Technologies (Euronext: DBV), creator of Viaskin, a new standard in the treatment of allergies, and Stallergenes (Euronext Paris CAC small), worldwide leader in allergen immunotherapy, have entered into a strategic research partnership.

HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst

20 May 2013

While the risks involved in HIV vaccine development have turned Big Pharma away from pursuing a preventative vaccine, government-funded organizations and smaller biotech firms may provide the answer, a GlobalData analyst has said in a research note as World AIDS Vaccine Day approaches.

Neovacs moving forward in rheumatoid arthritis, say analysts

17 May 2013

French biotech firm Neovacs (Alternext Paris: ALNEV) intends to initiate a Phase IIb trial with its lead product TNFalpha-Kinoid in rheumatoid arthritis (RA). The strategy is designed to maintain momentum of the programme while it seeks a partner.

Merck KGaA ups commitment to MS Ventures to 100 million euros

16 May 2013

Germany's Merck KGaA says that it will increase its commitment to its strategic corporate venture capital fund MS Ventures to 100 million euros ($130 million). MS Ventures was originally established in March 2009 with a 40 million euros commitment to invest in emerging biotechnology companies.

Improved voluntary harmonization procedure delivers significant benefits for multinational clinical trials in Europe

16 May 2013

The new Voluntary Harmonization Procedure (VHP), a voluntary procedure agreed by the Clinical Trials Facilitation Group (CTFG), a working group of the EU Heads of Medicines Agencies, provides a major breakthrough in getting a harmonized regulatory decision on a clinical trial to be performed in more than one European Union member state.

Australia's revised code to benefit ASX-listed life science companies

16 May 2013

Australia's Minister for Technology, Gordon Rich-Phillips, this week joined forces with the Australian Securities Exchange (ASX) and Australia's biotechnology industry association, AusBiotech, to launch a revised edition of the industry code of best practice that will support capital formation by ASX-listed life science companies.

Merck Serono Ph III trial of L-BLP25 fails endpoint in NSCLC

16 May 2013

Merck Serono, a division of Germany's Merck KGaA (MRK: DE), announced detailed results from the randomized Phase III START trial of its investigational MUC1 antigen-specific cancer immunotherapy L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC), showing the drug failed to meet its primary endpoint.

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