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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.

Merger between Intercell and Vivalis planned to complete soon

14 May 2013

French biotech firm Vivalis (Euronext: VLS) previously-announced acquisition of Intercell (ICEL.VI) in a deal valuing the Austrian vaccine maker at around 133 million euros ($174 million), and creating an enlarged entity in the European biotechnology sector under the name of Valneva, with stock market listings in Paris and Vienna (The Pharma Letter December 18, 2012) has reached the final step for closing the deal, which is described as a merger of equals, by filing of the relevant documents with the companies' register at the Commercial Court of Lyon, the French firm says.

Dr Reddy's 2012 revenues grew 20%, with earnings up 24%

14 May 2013

Dr Reddy's Laboratories (NYSE: RDY), India's second largest drugmaker, has announced its audited consolidated financial results for the fourth quarter and full year ended March 31, 2013, showing that consolidated revenues for the year were 116.3 billion rupees ($2.13 billion), recording year-on-year growth of 20%. Excluding the beneficial impact of olanzapine (Eli Lilly's antipsychotic drug Zyprexa) exclusivity in fiscal 2012, sales registered year-on-year growth of 26%.

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.

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