Millennium, a unit of Takeda Pharmaceutical Co. Ltd., may soon be able to add peripheral T-cell lymphoma (PTCL) to its list of cancers that can be treated with its investigational Aurora A kinase inhibitor, MLN8237 (alisertib). Read More
Canadian biopharma Medicago Inc. clinched a strategic alliance with Japan's Mitsubishi Tanabe Pharma Corp. (MTPC) by executing a master research collaboration agreement to develop and commercialize at least three vaccines using its virus-like particle (VLP) technology. Read More
A team of researchers has shown that transgenic mice with increased levels of the tumor suppressor PTEN have a longer life span than their wild-type brethren. Read More
Hoping to unlock much-needed access to the public market for emerging growth companies, the House expects to pass a legislative package later this week that would remove some of the barriers that have all but shut the initial public offering (IPO) door to small biotechs. Read More
The month of May could prove to be an important milestone in the evolution of drug regulation in Europe. Around then, Amsterdam Molecular Therapeutics (AMT) Holding NV expects to hear a final decision from the European Medicines Agency (EMA) on its dossier for gene therapy treatment Glybera (alipogene tiparvovec), which has traced a highly circuitous route through various European Union institutions over the past couple of years. Read More
InDex Pharmaceuticals AB is moving its lead drug candidate Kappaproct into a European Phase III trial in patients with chronic active ulcerative colitis who are unresponsive to other therapies. Read More
Less than two months after disclosing plans to trim its staff and kickstarting its commercial operations by in-licensing an approved hypertension drug, XOMA Corp. priced a public offering to raise about $39.2 million. Read More
• Biovista Inc., of Charlottesville, Va., said it received a research grant from the CFIDS Association of America to identify nonobvious mechanisms of chronic fatigue syndrome and potential drug repositioning candidates that will advance objective diagnosis and treatment. Read More
• Derma Sciences Inc., of Princeton, N.J., said it met with the FDA to discuss Phase II results of investigational compound DSC127, a topical angiotensin analogue, in diabetic foot ulcers. The FDA supported the initiation of pivotal Phase III studies and offered guidance on trial design and other clinical activities, according to the company, which plans to initiate the Phase III trials in the second half of the year. Read More
• Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for review a resubmission of a new drug application for perampanel (E2007) for partial onset seizures of epilepsy. Perampanel is an oral alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid-type glutamate receptor antagonist. Read More
• Shire plc, of Dublin, Ireland, began two Phase IV trials comparing Vyvanse (lisdexamfetamine dimesylate) capsules to Concerta (methylphenidate HCL) extended-release tablets. Read More
