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Bayer initiates Ph III Stivarga study in liver cancer; Sanofi enrolls sarilumab patients

15 May 2013

German drug major Bayer (BAYN: DE) says that patient enrollment is underway for RESORCE (Regorafenib after Sorafenib in Patients with Hepatocellular Carcinoma), an international Phase III trial to evaluate the efficacy and safety of Stivarga (regorafenib) for the treatment of patients with hepatocellular carcinoma (HCC) who have progressed on Nexavar (sorafenib) tablets, an anticancer drug for the treatment of patients with unresectable HCC.

Cempra out-licenses solithromycin to Toyama Chemical in Japan

15 May 2013

USA-based clinical-stage antibiotics developer Cempra (Nasdaq: CEMP) has signed an exclusive license and development agreement for solithromycin with Toyama Chemical, a subsidiary of FujiFilm Holdings in Japan.

Neurodegenerative diseases market to survive patent cliff, due to new therapeutics

15 May 2013

New market entrants are set to defend the neurodegenerative diseases market from the looming patent cliff, leading global market revenue to increase from $8.8 billion in 2012 to $11 billion in 2018, according to a new analysis by GBI Research.

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.

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.

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