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August 19, 2013

Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

LAKE SUCCESS, N.Y. — Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

CareMed said it had been selected to supply the drug, Tarceva (erlotinib). The two drug makers stopped distributing the drug, a once-daily treatment for advanced lung cancer, through retail pharmacies at the beginning of July.

July 24, 2013

Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said.

PITTSBURGH — Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said Wednesday.

Mylan said it had entered an agreement with Pfizer, Genentech and OSI that would allow their suit against Mylan over the drug Tarceva (erlotinib) to be dismissed. All other terms and conditions of the settlement are confidential, and the agreement is subject to Department of Justice and Federal Trade Commission review, Mylan said.

July 12, 2013

The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said Friday.

The FDA announced the approval of Gilotrif (afatinib) for patients with non-small cell lung cancer that has spread to other parts of the body and whose tumors include certain epidermal growth factor receptor gene mutations. The drug works by blocking proteins that promote the development of cancer cells.

July 2, 2013

A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

NEW YORK — A cancer drug made by Genentech and Astellas is no longer available through ordinary retail channels and is now available only through a limited-distribution network.

Cancer-focused specialty pharmacy Onco360 said that effective Monday, the drug Tarceva (erlotinib) would no longer be available through retail pharmacies and that had joined a limited-distribution network that the drug makers had set up for the drug. Tarceva is used for treating advanced non-small cell lung cancer and pancreatic cancer.

May 15, 2013

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

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

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

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

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

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 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

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

March 11, 2010

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

March 4, 2010

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

January 18, 2010

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