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May 15, 2013
FDA approves Genentech drug for lung cancer with genetic mutation

The Food and Drug Administration has approved a drug for a type of lung cancer.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

 

August 15, 2012
FDA approves Wockhardt enlarged prostate drug

The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

Wockhardt, based in Mumbai, India, announced the approval of alfuzosin hydrochloride extended-release tablets in the 10-mg strength, which is designed to treat enlarged prostate, also known as benign prostatic hyperplasia.

The drug is a generic version of Sanofi's Uroxatral. Various versions of the drug have sales of about $81.5 million, according to IMS Health.

March 30, 2012
Genentech announces results of cancer drug trial

Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.

SOUTH SAN FRANCISCO, Calif. — Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.

March 16, 2012
Patients taking oral cancer drugs may risk drug interactions, study finds

Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

December 9, 2010
Trial data of investigational lung cancer treatment said to extend survival by more than four months

An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

RIDGEFIELD, Conn. — An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

BI said the phase 2b/3 “LUX-Lung 1” trial of BIBW 2992 (afatinib) showed a fourfold increase in survival among advanced non-small cell lung cancer patients taking the drug versus those taking placebo, whose survival was extended by one month.

September 22, 2010
FDA accepts approval application for AstraZeneca's vandetanib

The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug,...

LONDON The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug, the Anglo-Swedish drug maker said Thursday.

 

AstraZeneca announced the FDA’s acceptance of its application for vandetanib, a drug for treating patients with advanced medullary thyroid cancer. The agency gave the drug priority review status and expected to take action on it in January.

 

 

August 26, 2010
Pfizer reports mixed results in late-stage clinical trial

Pfizer reported mixed results this week in a late-stage clinical trial combining two drugs in...

NEW YORK Pfizer reported mixed results this week in a late-stage clinical trial combining two drugs in patients with advanced non-small cell lung cancer.

The drug maker said the combination of Pfizer’s Sutent (sunitinib) and Tarceva (erlotinib), made by Genentech and OSI Pharmaceuticals, kept the disease from progressing, but did not improve patients’ overall survival, which was the trial’s primary goal. The company expects to present results at the European Society for Medical Oncology Congress in Milan in October.

June 7, 2010
Astellas completes acquisition of OSI

Japanese drug maker Astellas Pharma has completed its acquisition of OSI Pharmaceuticals, Astellas said Tuesday....

March 11, 2010
Pfizer says clinical trials for Sutent did not meet expectations; halts additional cancer treatment study

Two clinical trials of a Pfizer drug for treating advanced breast cancer have failed, Pfizer...

March 4, 2010
OrbiMed Advisors: Astellas should raise bid for OSI

One of the biggest holders of OSI Pharmaceuticals’ stock has said Japanese drug maker Astellas...

January 18, 2010
FDA extends review of lung cancer treatment

The Food and Drug Administration has extended its review period for a lung cancer drug...