Article Listing - Japan stock market week to Sept 8, 2008
US FDA advisory panel backs approval of Merck & Co's suvorexant, but only at lower doses
23 May 2013
The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee yesterday voted 13 to three to approve drug giant Merck & Co's (NYSE: MRK) investigational insomnia medicine suvorexant at doses of 15mg and 20mg, but voted eight to seven (with one abstention) against the 30mg and 40mg doses, saying that these were not safe.
Ranbaxy highlights its actions on improved business and quality assurance
23 May 2013
Indian drugmaker Ranbaxy Laboratories (BSE: 500359), whose US subsidiary was the subject of the biggest generics drugmaker settlement with the US Department of Justie over felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy's manufacturing facilities in India (The Pharma Letter May 14), has issued a statement highlighting some of the major specific actions the company has been taking in recent years to address certain conduct of the past and to ensure the safety and efficacy of all of its products currently available in the global market. These actions include:
Grifols gains global rights to Aradigm's Pulmaquin
23 May 2013
Spanish drugmaker Grifols (GRLS: MC) has signed an exclusive, worldwide license for USA-based Aradigm's (OTC BB: ARDM.OB) proprietary formulations of inhaled ciprofloxacin (brand names Pulmaquin and Lipoquin) for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). Aradigm has completed Phase IIb clinical trials in BE patients with Pulmaquin and Lipoquin.
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.
- Novo Nordisk's diabetes drug Victoza produced 8% weight loss in Ph III obesity trial
- Proposal to list Roche's Neulastim and Actemra in New Zealand
- Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux
- Positive new data on Novartis' Galvus in elderly type 2 diabetes patients
- Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth
