Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced on Monday the FDA has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE New Drug Application (NDA) will be discussed. In August 2011, Alexza received notification that the FDA had accepted the resubmission of the ADASUVE NDA and assigned a PDUFA goal date of February 4, 2012.
Affymax, Inc. (Nasdaq:AFFY) announced on Monday the FDA Oncologic Drugs Advisory Committee (ODAC) will review the NDA for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session. The FDA has established a PDUFA action date of March 27, 2012.
Cell Therapeutics, Inc. (NASDAQ: CTIC) announced on Tuesday that it has resubmitted the pixantrone New Drug Application for accelerated approval to treat relapsed or refractory aggressive non-Hodgkins lymphoma (NHL) in patients who failed two or more lines of prior therapy.
Adolor Corporation (NASDAQ: ADLR), entered into an Agreement and Plan of Merger with Cubist Pharmaceuticals, Inc on Monday. Cubist has agreed to purchase all of the issued and outstanding shares of Common Stock for $4.25 per share. Each Adolor stockholder will also receive one Contingent Payment Right (CPR), entitling the holder to receive additional payments of up to $4.50 for each share they own if certain regulatory approvals or commercialization milestones for ADL5945 are achieved.
Exelixis, Inc. (NASDAQ:EXEL) reported top-line results on Monday from the ongoing phase 3 clinical trial of cabozantinib in patients with advanced medullary thyroid cancer (MTC), known as the EXAM trial. The trial met its primary endpoint of improving progression-free survival (PFS) compared with placebo and substantially exceeded the threshold of a 75 percent increase in PFS originally assumed when the trial was designed. Cabozantinib significantly improved median PFS by 7.2 months compared with placebo. The median PFS on the cabozantinib arm was 11.2 months versus 4.0 months on the placebo arm with a hazard ratio (HR) 0.28.
Seattle Genetics, Inc. (Nasdaq: SGEN) announced on Tuesday that it has initiated a Phase 2 clinical trial of ADCETRIS(TM) (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors. The trial is designed to assess the antitumor activity and safety profile of ADCETRIS in these patients.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), announced on Tuesday that the it concluded a pre-New Drug Application (NDA) meeting with the FDA related to its investigational drug candidate, RP103 (delayed-release formulation of cysteamine bitartrate), for the treatment of nephropathic cystinosis. The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for its NDA submission, which the it intends to file in 1Q 2012, as previously announced.
Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) yesterday announced it has completed enrollment in the Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibodypositive systemic lupus erythematosus (SLE). The proposed interim efficacy analysis would be completed in Q1 2012 with the possibility of stopping the study early for efficacy using a pre-defined stopping rule.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it met with the FDA to discuss a single clinical study to support approval of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation of Taxotere (docetaxel). ADVENTRX proposed a non-inferiority study (Study 514-02) with a primary objective of comparing fluid retention following treatment with ANX-514, administered without corticosteroid premedication, and Taxotere, administered with corticosteroid premedication, which would enroll approximately 400 patients. The FDA agreed that the proposed study would generate sufficient clinical data to support approval of ANX-514 without requiring corticosteroid premedication, resulting in a possible NDA filing during 2014.