Article Listing - Expanded indication for Actelion's PAH drug
Europe adopting US strategies to diagnose and treat ADHD
16 May 2013
The impending publication of the fifth edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-V) later this month may affect diagnosis rates of conditions such as attention-deficit hyperactivity disorder (ADHD), both in the USA and worldwide, says new analysis by GBI Research.
US Senate confirms appointment of Marilyn Tavenner as CMS Administrator
16 May 2013
US Health and Human Services (HHS) Secretary Kathleen Sebelius announced that the US Senate has confirmed Marilyn Tavenner as Administrator of the Centers for Medicare & Medicaid Services (CMS).
Fast FDA approval for Bayer's new drug for advanced prostate cancer, Xofigo
16 May 2013
The US Food and Drug Administration yesterday (May 15) approved Xofigo (radium Ra 223 dichloride, initially called Alpharadin), from German drug major Bayer (BAYN: DE), to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer.
Merck Serono and Quintiles enter novel clinical development partnership
16 May 2013
Merck Serono, the biotech division of Germany's Merck KGaA (MRK: DE) and Quintiles (NYSE: Q) have announced a new, five-year clinical development agreement. This strategic collaboration is the first-of-its-kind between a biopharmaceutical company and a biopharmaceutical services provider, creating a comprehensive process that integrates the expertise and experience from both organizations into a single, well-aligned clinical development engine, the German firm says. Financial terms of the accord were not revealed.
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.
- Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines
- Elan makes "transformational" acquisitions and a divestment
- HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst
- CIS countries prepare for the introduction of drug reimbursement schemes
- Greek research-based drugmaker group AIFD challenges generics assumptions in Draft Patent Law
