Article Listing - Pharmaceutical
US and European hema-oncologists views therapies for relapsed/refractory multiple myeloma
15 May 2013
US and European hematological oncologists surveyed by health care advisory firm Decision Resources indicate that overall survival is the factor that most influences their prescribing decisions for relapsed/refractory multiple myeloma, and that increased overall survival is associated with the highest level of unmet need.
US FDA approves companion diagnostic for Tarceva, and new indication for the Roche drug
15 May 2013
The US Food and Drug Administration late yesterday (May 14) approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech's cobas EGFR Mutation Test, a companion diagnostic for their cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non-small cell lung cancers (NSCLC), the regulatory agency noted.
Astellas reorganizes research framework, including closing OSI Pharma and Perseid
15 May 2013
Japanese drug major Astellas Pharma (TYO: 4503) has announced plans to reshape its research framework by introducing new initiatives to further enhance the ability to generate innovative drugs.
AbbVie and Alvine link up on investigational oral therapy for celiac disease
15 May 2013
US drugmaker AbbVie (NYSE: ABBV) and privately-held Alvine Pharmaceuticals, a leader in celiac disease therapeutics development, have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase II development.
Australia's 2013-14 Budget includes investment in health services and PBS
14 May 2013
The Australian government today (May 14) presented its Budget for 2013-2014, saying that it delivers A$43 billion ($43 billion) in savings to return the budget to surplus and fund key nation-building reforms.
CMC Biologics and RuiYi link on MAb; Deal for Cynviloq rights in EU
14 May 2013
Denmark and USA-based contract manufacturers CMC Biologics has entered into an agreement with China's RuiYi to develop a cell line for RYI-008, a novel anti-inteleukin-6 monoclonal antibody. CMC Biologics' proprietary CHEF1 high-productivity expression plasmid will be utilized for the cell line development to optimize cell growth, and consistent, high-level protein expression in a rapid time frame. Specific terms of the agreement were not disclosed.
Rx drugs bulk buying may save governments money but poses a risk for some patients, says Canadian think-tank
14 May 2013
Governments that opt for prescription drug bulk-purchasing agreements can save taxpayers money but at the risk of reducing patient health by limiting access to optimal medicines, concludes a new report from the Fraser Institute, an independent, non-partisan Canadian public policy think-tank.
Countries must fix critical access to medicines flaws in Trans-Pacific Trade Pact, says MSF
14 May 2013
As negotiations for the Trans-Pacific Partnership (TPP) restart in Lima, Peru, tomorrow (May 15), countries must prioritize fixing critical flaws in the agreement that could leave millions of people in developing countries with limited access to affordable generic medicines, international medical humanitarian organization Medecins Sans Frontieres (MSF) said today.
BioAlliance updates on Livatag development
14 May 2013
French orphan cancer drug developer BioAlliance Pharma (Euronext Paris: BIO) says that the International Independent Board of Experts' Data and Safety Monitoring Board (DSMB) again recommended continuing the ReLive Phase III trial without modification.
India-developed rotavirus vaccine demonstrates strong efficacy
14 May 2013
In a public-private partnership, the Indian government's Department of Biotechnology (DBT) and Bharat Biotech announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India. Data from the trial, presented at the International Symposium on Rotavirus Vaccines for India - The Evidence and the Promise, showed ROTAVAC to have an excellent safety and efficacy profile, is reported by EurekAlert.
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- Is failure to adopt business process management putting the pharma industry at risk?
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- Sanofi and Regeneron's dupilumab shows 87% reduction in risk of asthma exacerbations
- Ignyta acquires Actagene Oncology and entry into cancer personalized medicine
