Article Listing - Working together for self-care: UK's lead in prescription to OTC switching
AstraZeneca plans to move three cancer drug candidates into Ph III
16 May 2013
Anglo-Swedish drug major AstraZeneca (LSE: AZN) this morning (May 16) announced that it will be moving three of its cancer compounds: moxetumomab pasudotox, olaparib and selumetinib into Phase III clinical development.
FDA approves Arbor Pharma's Nymalize for use in certain brain hemorrhage patients
15 May 2013
Privately-held US firm Arbor Pharmaceuticals says that the US Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution, marking the first NDA approval for the company.
Encouraging results with Sangamo's SB-728-T in HIV treatment
15 May 2013
USA-based Sangamo BioSciences (Nasdaq: SGMO) has presented new clinical data from its program to develop a ZFP Therapeutic for HIV/AIDS. The data, which demonstrate that SB-728-T treatment results in a reduction in the HIV reservoir in HIV-infected subjects, are being presented at the 16th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), in Salt Lake City from May 15-18.
Launching new drugs in the Outcome Era; report
15 May 2013
The pharmaceutical industry is facing the Outcome Era. Launching a novel drug today obliges companies to convince on its value. They have to prove the best possible health outcomes and additional benefit to achieve adequate price and reimbursement, according to a new report from Camelot Management Consultants.
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.
- 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
