Article Listing - Jazz' net loss deepens to $46.7M in 1st qtr
NICE rejects Avastin for ovarian cancer, but backs Lucentis for RVO
22 May 2013
The UK's drugs watchdog the National Institute for Health and Care Excellence (NICE) has this morning (May 22) advised the National Health Service against funding the drug Avastin (bevacizumab) from Swiss drug major Roche (ROG: SIX) for advanced ovarian cancer. In two separate pieces of final guidance published for the health service, NICE concludes that funding the treatment on the NHS does not represent the best use of taxpayers' money.
AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
22 May 2013
Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday (May 21) presented the results of two pivotal Phase III studies of naloxegol showing the 25mg dose of the investigational drug met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies for the treatment of opioid-induced constipation (OIC), at the Digestive Disease Week (DDW) meeting in Orlando, Florida, USA.
Biogen Idec files BLA for MS drug Plegridy in USA
21 May 2013
US biotech company Biogen Idec (Nasdaq: BIIB) has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for approval of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS).
New Zealand declines Alexion's funding application for Solaris
21 May 2013
New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to decline the application from USA-based drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) for funding its drug Solaris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, potentially life-threatening disease of the blood.
Vectura fiscal 2012/13 revenues beat own expectations, and loss narrows
21 May 2013
UK inhaled therapies developer Vectura Group (LSE: VEC) yesterday presented its preliminary results for the year ended March 31, 2013, posting revenues slightly ahead of expectations at £30.5 million ($46.3 million), but down compared with £33 million in 2011/12.
CML drug revenue in Japan to grow, despite global decline, says GlobalData
21 May 2013
Bucking a global trend of falling revenues, weak penetration of generic drugs and an increasing patient population will ensure steady growth of Japan's Chronic Myeloid Leukemia (CML) market over the next decade, forecasts a new report from research and consulting firm GlobalData.
Novo A/S acquires Norway's Xellia Pharmaceuticals in $700 million deal
21 May 2013
Denmark-based Novo A/S, the holding company of the Novo Group and the major shareholder in Novo Nordisk and Novozymes, has purchased all shares of the Norwegian firm Xellia Pharmaceutical for around $700 million from 3i and other current shareholders. As a consequence of the transaction, Xellia will revert to Danish ownership with headquarters in Copenhagen.
Ignyta acquires Actagene Oncology and entry into cancer personalized medicine
21 May 2013
Privately-held US biotechnology company, Ignyta, which engages in catalyzing personalized medicine in autoimmune diseases, says it has acquired Actagene Oncology, effective May 20. Actagene was a San Diego-based privately held biotechnology company founded in February 2013 that was developing personalized medicines for high unmet need cancer indications, based on cancer genome mining and sequencing. Financial terms of the transaction were not disclosed.
Is failure to adopt business process management putting the pharma industry at risk?
21 May 2013
The dynamic pharmaceutical, biotech and life-science sectors are constantly evolving. With frequent mergers, acquisitions, competitive pressures and the need to meet stringent regulation, companies operating in this arena need to be able to analyze and streamline core business processes - as well as deliver corporate and regulatory governance to the highest standards, say Jeff Fraleigh, US senior vice president and Eileen Cairo, senior consultant at Casewise, in a contributed article for The Pharma Letter.
Pace of drug approvals to moderate for global pharma companies, says Fitch Ratings
21 May 2013
Global pharmaceutical novel drug approvals will moderate in 2013 due to the exceptional research success in 2012, according to a Fitch Ratings report.
- 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
