Tag:

Paclitaxel

Latest Headlines

Latest Headlines

Avastin re-submitted to FDA

Perhaps the second time is the charm for Genentech. The biotech has re-submitted a sBLA to the FDA for Avastin in combination with paclitaxel chemotherapy as a first-line treatment for metastatic

Press Release: Phase III Trial of Nexavar Does Not Meet Primary Endpoint

Press Release: Phase III Trial of Nexavar Does Not Meet Primary Endpoint

SPOTLIGHT: Synta gets fast track for cancer therapy

The FDA has granted Synta Pharmaceuticals fast-track status for its lead oncology drug candidate, STA-4783. In a recently completed, Phase IIb clinical trial in patients with Stage IV metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival. Synta was a 2004 …

Press Release: Synta Pharmaceuticals gets FDA Fast Track Designation for STA-4783

Synta Pharmaceuticals gets FDA Fast Track Designation for STA-4783

Editor's Corner

Several comments came in about yesterday's editor's note on the need for price caps on some of the new and more expensive therapies hitting the market. Seattle-based Gail …

SPOTLIGHT: Synta trial hits endpoint

Synta Pharmaceuticals says that a Phase IIb clinical trial of STA-4783 doubled the progression free survival time of volunteers with metastatic melanoma in the study, hitting the study's primary endpoint for statistical significance. Median PFS for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for those receiving paclitaxel alone. Report

ALSO NOTED: Barr raises bid on Pliva; Synta touts new data; regulators question Factive rashes;and much more...

> Barr Pharmaceuticals has raised its bid for Pliva to $2.5 billion. Report > Synta Pharmaceuticals has released positive Phase IIB data for STA-4783, a heat shock protein 70 inducer that activates natural killer cell-mediated tumor killing in metastatic melanoma. Median progression free survival for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for …

ALSO NOTED: FDA wants new NeoPharm trial; GSK may bid for Pfizer's OTC unit; and much more...

> NeoPharm says the FDA has requested that it undertake a new clinical trial to support its application for approval of a new formulation of the cancer drug liposomal paclitaxel. Report > The Garvan Institute of Medical Research in Australia has found a new antibody for inflammatory diseases and that Novo Nordisk had agreed to provide up to $100 million to take it …

ALSO NOTED: FDA requires electronic drug labeling; Niccotine vaccine on the horizon; Cancer drug could fight scleroderma; and m

> The FDA said Wednesday that drug makers must begin submitting electronic versions of their drug labels to build a database that doctors and patients can search for recent warnings or other changes. Release > Researchers presenting at the American Association for Cancer Research meeting in Baltimore on Wednesday reported strong safety and efficacy results for NicVAX, a vaccine that could help millions of …

ALSO NOTED: FDA wants more safety data on Pargluva; Genentech disappointed by Tarceva, Avastin combo; Schering takes stake in S

> The FDA issued an "approvable" letter for Bristol-Myers Squibb's Pargluva but wants more safety data before it allows the drug to be marketed. An expert panel had recommended approval despite staff concerns about cardiovascular problems. Report > Genentech has decided to abandon studies of a combined regimen of Tarceva and Avastin for kidney cancer after finding the …