Article Listing - Roche's Tasmar Approvable In USA
Boehringer Ingelheim gets FDA warning letter on cGMP failures
22 May 2013
German family-owned drug major Boehringer Ingelheim today (May 22) revealed that the US Food and Drug Administration issued a warning letter concerning its manufacturing practices following an agency inspection in Ingelheim, Germany, in November 2012. The matter also concerned foreign particles detected in batches of active pharmaceutical ingredients.
Baxter and Halozyme's HyQvia approved in European Union
22 May 2013
USA-based Baxter International (NYSE: BAX) and Halozyme Therapeutics (Nasdaq: HALO) say that the European Commission has granted Baxter marketing authorization in all European Union member states for the use of HyQvia, a product consisting of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, as replacement therapy for adult patients with primary and secondary immunodeficiencies.
Positive trial results for Otsuka and Lundbeck's Abilify Maintena in schizophrenia
22 May 2013
Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578)) and Denmark's Lundbeck (LUND: DC) today (May 22) announced results from a preliminary analysis that showed statistically significant reductions (p<0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly Abilify Maintena - an extended-release injectable suspension formulation of aripiprazole - compared to previous treatment with daily standard-of-care (SOC) oral antipsychotics. These data were presented in a poster at the 166th American Psychiatric Association Annual Meeting in San Francisco.
Generic medicines pricing reforms deliver significant savings to Australian government, says CSES report
22 May 2013
Australia's 2010 Pharmaceutical Benefits Scheme (PBS) reforms have delivered the government significant savings. A report by Centre for Strategic Economic Studies, released this week, estimates that savings to government and general patients (non-health-card holding patients) will be up to A$18 billion ($17.53 billion) over eight years.
Sanofi and Regeneron's dupilumab shows 87% reduction in risk of asthma exacerbations
22 May 2013
French drug major Sanofi (Euronext: SAN) and US biotech partner Regeneron Pharmaceuticals (Nasdaq: REGN) announced that the New England Journal of Medicine published on-line the positive Phase IIa study results of dupilumab (SAR231893/REGN668) in patients with moderate-to-severe allergic asthma.
R-Pharm to invest 100 million euros in building a Turkish production plant
22 May 2013
R-Pharm, one of Russia's leading pharmaceutical producers, has officially announced the initiation of production of its drugs in Turkey and the possibility of establishment of its own manufacturing facility in the country.
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.
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- New Zealand declines Alexion's funding application for Solaris
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- Sanofi and Regeneron's dupilumab shows 87% reduction in risk of asthma exacerbations
