Article Listing - Par Pharma starts shipping generic Miacalcin
Netherlands first to approve Astellas' Vesomni
23 May 2013
The European subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says that the Dutch Medicines Evaluation Board (MEB) has granted marketing authorization for Vesomni in the Netherlands, the first clearance for the drug, for treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy.
Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux
23 May 2013
Australian drug developer Alchemia (ASX: ACL) and Merck Serono, a subsidiary of Germany's Merck KGaA (MRK: DE) have agreed to collaborate by supporting the initiation of a new clinical trial of HA-Irinotecan which will be conducted by principal investigator associate Professor Peter Gibbs. Financial terms were not disclosed.
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.
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- Italy's pharma market slump set to continue, warns GlobalData
- Is failure to adopt business process management putting the pharma industry at risk?
- Sanofi and Regeneron's dupilumab shows 87% reduction in risk of asthma exacerbations
