Article Listing - Expanded indication for Actelion's PAH drug
Pfizer to split-off remaining 80% interest in Zoetis
22 May 2013
Zoetis Inc (Nasdaq: ZTS), the animal health business of which US pharma behemoth Pfizer (NYSE: PFE) spun out 20% in an initial public offering raising $2.2 billion (The Pharma Letter January 20), intends to file a Registration Statement on Form S-4 with the Securities and Exchange Commission (SEC) in connection with the proposed exchange offer announced by Pfizer.
GlaxoSmithKline gets $200 million BARDA award to develop new antibiotics
22 May 2013
UK pharma giant GlaxoSmithKline (LSE: GSK) and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), have agreed to a first of its kind collaboration that will support the development of several antibiotics to fight antibiotic resistance and bioterrorism.
Italy's pharma market slump set to continue, warns GlobalData
22 May 2013
The value of Italy's pharmaceutical market will continue to fall in the foreseeable future, due to government support of generics and a stringent drug pricing policy, states the latest report from research and consulting firm GlobalData.
Swedish registry questions superiority of bivalirudin over heparin in patients undergoing PCI for NSTE-ACS
22 May 2013
Results from a large observational study reported at EuroPCR 2013 (the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions; EAPCI) this week question whether bivalirudin - The Medicines Company's (Nasdaq: MDCO) Angiomax - is superior to heparin in the absence of GPIIb/IIIa blockade, showing similar 30-day mortality in patients with non-ST segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
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.
- 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
