Having scored landmark phase III success against Duchenne muscular dystrophy (DMD) with idebenone, an oral drug that does not depend on patients' mutational status, Santhera Pharmaceuticals AG is heading to the FDA to talk about next steps. Read More
LONDON - Pfizer Inc. has increased the pressure on Astrazeneca plc, publishing a presentation to the UK company's shareholders in which it outlines the strategic rationale for the proposed £63 billion (US$107 billion) takeover, and hints it is prepared to increase the offer. Read More
Despite the prevailing uncertain financial markets, the lure of going public has not diminished for biotech companies, with New Haven, Conn.-based Marinus Pharmaceuticals Inc. joining a list of 18 other companies currently lining up on the initial public offering (IPO) runway. Read More
Mabvax Therapeutics Inc., a privately held cancer immunotherapy company, is taking the fast lane to Nasdaq through a merger with publicly traded Telik Inc., which will fade out in the deal's wake. Read More
Aganirsen, a topical antisense drug in development for treating inflammation-related corneal neovascularization (CNV), failed to reach the primary endpoint of visual acuity in a phase III trial, but its developer Gene Signal International SA plans to start a confirmatory trial later this year based on a different endpoint, having seen a significant reduction in the extent of neovascularization between the two treatment groups. Read More
SHANGHAI – Aslan Pharmaceuticals Pte Ltd. signed an agreement for global rights with CSL Ltd. to develop an anti-IL-13 receptor monoclonal antibody, CSL334, for severe to moderate asthma. Read More
HONG KONG – Chinese University of Hong Kong (CUHK) researchers reported being unable to replicate controversial research purporting to create stimulus-triggered acquisition of pluripotent (STAP) stem cells, which behave like induced pluripotent stem (iPS) cells, by simple acid-based treatment of somatic cells, suggesting that the method is not as simple or as straightforward as initially claimed. Read More
The FDA released the latest installment in its series of draft biosimilar guidances Tuesday, but it's not the one many drugmakers are anxiously awaiting. The newest guidance discusses the design and use of clinical pharmacology studies. Pharmacokinetic (PK) and pharmacodynamic (PD) data are required as part of the FDA's stepwise approach to demonstrating biosimilarity to the reference drug. Read More
Jubilant Biosys Ltd., of Bangalore, India, and Orion Corp., of Espoo, Finland, disclosed a drug discovery collaboration to discover small-molecule inhibitors in the neuroscience therapeutic area. Read More
Basilea Pharmaceutica Ltd., of Basel, Switzerland, reported that a phase III trial showed its antibiotic ceftobiprole to demonstrate more rapid clinical responses in hospital-acquired pneumonia and community-acquired pneumonia than a comparator regimen. Read More
Janssen Pharmaceuticals Inc., of Titusville, N.J., a unit of Johnson & Johnson, said it submitted a supplemental new drug application for once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to the FDA for approval to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Read More
Arena Pharmaceuticals Inc., of San Diego, reported that for the first quarter ending March 31, approximately 77,000 prescriptions for Belviq (lorcaserin HCl) were filled, according to IMS Health, representing growth of approximately 31 percent in total prescriptions as compared to the previous quarter. Read More
Astrazeneca plc, of London, reported phase III data showing that the combination of saxagliptin/dapagliflozin, as a dual add-on therapy in adults with type 2 diabetes who were inadequately controlled on metformin, resulted in statistically significant reductions in HbA1c with the combination vs. either agent alone. Read More
