AcelRx Pharmaceuticals completes End-of-Phase 2 meeting with the FDA for its ARX-01drug/device

AcelRx Pharmaceuticals, Inc. today announced that it has successfully completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device combination product based on the company’s proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route.

Isotechnika Pharma develops portfolio of NICAMs with potent cyclophilin inhibition

Isotechnika Pharma Inc. today announced that it has developed a portfolio of non-immunosuppressive cyclosporine analogue molecules (NICAMs) with potent cyclophilin inhibition. Cyclophilin inhibition has garnered considerable attention as a novel therapy in the treatment of a wide range of diseases including hepatitis C, stroke, and chronic neurological disorders such as Parkinson’s, Lou Gehrig’s, and Alzheimer’s.

Studies demonstrate that investigational cancer vaccines show encouraging immune response rates

Results of two phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for phase 2 studies.

Dynavax Technologies announces first clinical data for HEPLISAV investigational hepatitis B vaccine

Dynavax Technologies Corporation today announced the first clinical data for HEPLISAVTM investigational hepatitis B vaccine in chronic kidney disease patients.

VIVUS presents additional data on Qnexa Phase 3 trials

VIVUS, Inc. today announced that additional data on Qnexa(TM), an investigational drug candidate for obesity, was presented at the 27th annual scientific meeting of The Obesity Society (TOS) in Washington D.C. Wesley W. Day, PhD, vice president of clinical development at VIVUS, presented the additional data from the company’s two year-long phase 3 obesity trials [...]

Pharmaceutical Companies Accept Ecuador’s Decision To Break Drug Patents

Foreign pharmaceutical companies on Wednesday accepted the decision of Ecuador’s President Rafael Correa to enable the country “to bypass patents on 2,000 drugs in order to produce them locally or buy cheaper versions elsewhere,” Agence France-Presse reports. “‘We accept the democratic decision …

Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo(R) New Drug Application

Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of [...]

Tamaulipas Comparative Wound Healing Test Treatment Successfully Concluded

The comparative study of chronic wound treatment at the Hospital Civil of Cd. Victoria, Tamaulipas, Mexico, was concluded successfully. Due to the significantly superior therapeutic success the Ministry of Health ordered the control to be abandoned and moved to Hemospray treatment for ethical reasons. 22 of the 24 patients within the Hemospray group were healed [...]

China Medicine announces acquisition of Guangzhou LifeTech Pharmaceuticals

China Medicine Corporation, a developer and leading distributor of prescription and over-the-counter pharmaceuticals, traditional Chinese medicines (”TCM”), nutritional and dietary supplements, and medical devices and medical formulations, today announced that through its wholly-owned subsidiary in China, Konzern Pharmaceuticals, it has signed an equity transfer agreement (the “Transfer Agreement”) to acquire 100% of equity interests in [...]

Impax Laboratories initiates patent challenge for TRICOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg.