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news.Innocoll files IND application for CollaRx
Under the investigational new drug (IND) application, Innocoll initially plans to conduct a two-way, placebo-controlled, multi-centered Phase II clinical trial in patients with a painful chronic skin ulcer.
Under the investigational new drug (IND) application, Innocoll initially plans to conduct a two-way, placebo-controlled, multi-centered Phase II clinical trial in patients with a painful chronic skin ulcer.
Under the terms of the agreement, Dara BioSciences will develop and commercialize products, while Bayer will receive an upfront payment, milestone payments and royalties during the development and
Genta’s Phase III trial, known as Agenda, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone.
Tumor-activated prodrug (TAP) compound, SAR3419, is a potential new treatment for non-Hodgkin’s lymphoma and other B-cell malignancies comprises Immunogen’s CD19-targeting monoclonal antibody and DM4 cell-killing agent. The first
Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) was developed through a joint venture partnership between Bristol-Myers Squibb and Gilead Sciences. Atripla combines sustiva (efavirenz) manufactured by Bristol-Myers Squibb,
The designation is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency. Picoplatin is currently being studied in the pivotal Phase
Under the terms of the agreement, ImClone Systems, Bristol-Myers Squibb and Merck will develop Erbitux for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC),
Two of the dosage forms (2mg/mL 5mL and 2mg/mL 75mL) are unique codes and are not currently available in the market. The remaining two dosage forms (2mg/mL 25mL
The lyophilized version of fludarabine, which is the generic equivalent of Fludara (fludarabine phosphate) for injection distributed by Bayer HealthCare Pharmaceuticals, will be packaged in 50mg/2mL single-dose vials.
FDA believes that the PreGen-Plus assay is a medical device requiring pre-market approval or clearance. Jeffrey Luber, president of Exact Sciences, commented: “Having spoken with the FDA regarding