Content about Filgrastim

October 22, 2013

Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

June 18, 2013

Royalty Pharma will not buy Irish drug maker Elan Corp., the company said Tuesday.

NEW YORK — Royalty Pharma will not buy Irish drug maker Elan Corp., the company said Tuesday.

Royalty said it would withdraw a request for a review by the Irish Takeover Panel after Elan shareholders voted in favor of a share buyback. Elan said last week that it would begin a process of selling itself to Royalty, which had previously offered $13 per share for the company.

November 16, 2012

Kroger announced Thursday it will acquire the outstanding shares of Axium Pharmacy Holdings, a leading specialty pharmacy, and merge the two companies. By now, it should be clear that specialty is becoming an increasingly important part of the retail pharmacy mix, having grown more than sixfold in revenues between 2000 and 2011, with everyone from Rite Aid to Costco to Hy-Vee biting off a piece for themselves.

As Specialty Pharmacy magazine reported in its fall 2012 issue, specialty drug development is starting to play a much bigger role in drug development overall than traditional pharmaceuticals. According to the IMS Institute for Healthcare Informatics, seven of the top 20 drug therapy classes will be in specialty by 2016, including cancer, autoimmune disorders and antivirals, and specialty and bioengineered drugs remain one of the few growth centers in the drug industry in 2012. And according to Express Scripts, the market for specialty and bioengineered drugs is expected to grow from 2011's 17.1% to 22% by 2014.

Kroger announced Thursday it will acquire the outstanding shares of Axium Pharmacy Holdings, a leading specialty pharmacy, and merge the two companies. By now, it should be clear that specialty is becoming an increasingly important part of the retail pharmacy mix, having grown more than sixfold in revenues between 2000 and 2011, with everyone from Rite Aid to Costco to Hy-Vee biting off a piece for themselves.

August 30, 2012

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

JERUSALEM — The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

January 19, 2012

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 10, 2012

Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

LAKE FOREST, Ill. — Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

The company said the phase-3 trial of biosimilar EPO (erythropoietin) would compare its product with Amgen's Epogen in patients with kidney dysfunction who have anemia. The trial, which will enroll about 1,000 patients who already have taken Epogen, follows a phase-1 trial that ended last year, and results of the late-stage trial are expected next year.

September 29, 2010

The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker...

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

 

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

 

 

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

 

February 1, 2010

The Food and Drug Administration has accepted a regulatory approval application from Teva Pharmaceutical Industries...