Article Listing - Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin
Is the diabetes market facing a blockbuster-free future?
23 May 2013
Japanese drug major Takeda's (TYO: 4502) recently announced positive late-stage results for new type 2 diabetes drug, fasiglifam, has prompted excitement within the industry and raised hopes of reviving Takeda's diabetes treatment business, following last year's patent expiration of hit product Actos (pioglitazone). But as drugs continue to improve without the addressing the biggest unmet needs of the current therapy landscape, an analyst with research and consulting firm GlobalData asks, are we entering an era without blockbuster diabetes drugs?
EMA makes key recommendations to tackle the issue of medication errors
23 May 2013
The European Medicines Agency yesterday issued six key recommendations to tackle the issue of medication errors causing harm in the European Union. These recommendations are described in the medication-errors workshop report, which is available on the Agency's web site.
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.
- Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- US FDA advisory panel backs approval of Merck & Co's suvorexant, but only at lower doses
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- Positive new data on Novartis' Galvus in elderly type 2 diabetes patients
