• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported top-line results from the GEMINI I Phase III study of vedolizumab in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including tumor necrosis factor-alpha antagonists. Both phases of the year-long trial met their primary endpoints, providing statistically significant improvements in clinical response in the six-week induction phase and clinical remission in the subsequent maintenance phase. Read More
• S1 Pharmaceuticals Inc., of Jersey City, N.J., said it submitted an investigational new drug application for Phase Ib studies of SIP-104 (Lorexys), its lead candidate for hypoactive sexual desire disorder (HSDD) and female sexual dysfunction. Lorexys is a fixed-dose combination in an oral enteric formulation aimed at treating HSDD both as a standalone and as an adjunct to testosterone therapy. Read More
• Cellartis AB, of Gothenburg, Sweden, a division of Cellectis SA, said it will participate in the €2 billion (US$2.69 billion) Innovative Medicines Initiative (IMI), a public-private European initiative to speed the development of new therapeutics. The IMI is supporting collaborative research projects, including an initial effort to develop a preclinical liver test system that surpasses the predictive power of the drug-induced liver injury (DILI) test. Read More
• Marshall Edwards Inc., of San Diego, is seeking to raise up to $8 million through a rights offering to existing shareholders. Majority shareholder Novogen Ltd. plans to exercise rights for up to $4 million of common stock and distribute a portion of its rights to its shareholders, subject to shareholder approval. Read More
VANCOUVER, British Columbia – The scientist who discovered beta-secretase (BACE1) and has been highly influential in making it one of the most popular drug targets in Alzheimer's disease now has said inhibiting that enzyme "could impair memory." Read More
Shares in Amsterdam Molecular Therapeutics Holding NV (AMT) fell by almost 19 percent Friday on news that venture capital investor Forbion Capital Partners had tabled an offer that would secure the company's immediate financial future, while taking it private in a manner that could ultimately result in small shareholders being squeezed out. Read More
VANCOUVER, British Columbia – After the initial hype and some eye-watering investments, big pharma has abandoned the field of silent interfering RNA (siRNA) in the face of seemingly insuperable problems in getting those constructs to their targets. Read More
WASHINGTON – Flexing its regulatory discretion, the FDA curbed two critical cancer drug shortages by speeding approval of a new source for preservative-free methotrexate and allowing the temporary importation of Lipodox as an alternative to Doxil. Read More
Threshold Pharmaceuticals Inc. saw shares rocket as high as 88 percent Tuesday morning after the company reported its Phase IIb study evaluating TH-302 in advanced pancreatic cancer hit its primary endpoint. Read More
