Article Listing - Nabi Submit PLA For H-BIG
Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth
24 May 2013
At a meeting today with industry analysts, senior leaders from the Janssen pharmaceutical companies of US health care giant Johnson & Johnson (NYSE: JNJ) yesterday (May 23) announced they anticipate submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017.
Merck & Co drops development of PD candidate preladenant
24 May 2013
Following review of three separate Phase III studies of preladenant, US pharma giant Merck & Co (NYSE: MRK) said that these did not provide evidence of efficacy for this investigational adenosine A2A receptor antagonist in the treatment of Parkinson's disease (PD).
AAA enters supply deal with Eli Lilly for Amyvid in France, Italy and Spain
24 May 2013
France-based molecular nuclear medicine firm Advanced Accelerator Applications (AAA) says it has signed a non-exclusive manufacturing and service agreement to supply US pharma major Eli Lilly's (NYSE: LLY) Amyvid (florbetapir (18F)) solution for injection in France, Italy and Spain.
Positive new data on Novartis' Galvus in elderly type 2 diabetes patients
23 May 2013
Results of the INTERVAL study were published on line in The Lancet today (May 23) and for the first time demonstrated the feasibility of setting and achieving individualized treatment targets in elderly patients with type 2 diabetes.
Alexza deal with Teva sets stage for Adasuve, say analysts
23 May 2013
USA-based Alexza Pharmaceuticals' (Nasdaq: ALXA) US marketing deal with Israel-headquartered Teva Pharmaceutical Industries (NYSE: TEVA) for Adasuve (orally-inhaled Staccato loxapine; The Pharma Letter May 9) enhances the product's US sales prospects given Teva's expertise in the psychiatric and hospital markets, say analysts at Edison Investment Research.
Exec appointments at Biogen Idec and Halozyme; Succession plan for Forest Labs
23 May 2013
US biotech firm Biogen Idec (Nasdaq: BIIB) announced that Spyros Artavanis-Tsakonas, has been named chief scientific officer. Dr Artavanis-Tsakonas had served as interim CSO while on sabbatical from Harvard Medical School.
Positive clinical results for Zensun's Neucardin CHF patients
23 May 2013
USA and China-based Zensun Science & Technology has revealed positive results of four completed Phase II clinical trials including three double-blind, placebo-controlled studies conducted in China and Australia and interim results from the US Phase II trial for Zensun's innovative "first-in-class" anti-heart failure drug, Neucardin, which has just been licensed to the USA's SciClone Pharmaceuticals (Nasdaq: SCLN) for Greater China (The Pharma Letter May 20).
Health care reforms not keeping pace with needs of Canadians, says report
23 May 2013
The Health Council of Canada today (May 23) released Progress Report 2013: Health care renewal in Canada, highlighting the progress achieved by governments in five key areas: wait times, primary health care and electronic health records, pharmaceuticals management, disease prevention/health promotion and Aboriginal health. The report finds that, overall, efforts at reform are not keeping pace with the changing health care needs of Canadians. There is variability of access to services across the country.
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.
- 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
