Content about Amgen

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

Amgen announced the approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively.

THOUSAND OAKS, Calif. — Amgen has launched an educational campaign that targets women with postmenopausal osteoporosis at increased risk for fractures.

The drug maker said that to promote its Act 2 Reduce Fractures campaign, which is supported by American Bone Health, the Global Healthy Living Foundation and the Older Women's League, the company has tapped award-winning actress Blythe Danner, who was diagnosed with the disease, to encourage women to learn of the risk factors and ways to improve their condition.

THOUSAND OAKS, Calif. — Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

The U.S. District Court in Pennsylvania has barred Teva from selling its human G-CSF (human granulocyte colony-stimulating factor) product Neutroval in the United States until Nov. 10, 2013. What's more, the court's injunction extends to Teva's other human G-CSF product, Neugranin. Teva will not sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen's patents are not infringed by Neugranin.

THOUSAND OAKS, Calif. — A cancer drug made by Amgen reduced the chances of prostate cancer spreading to the bones, according to results of a late-stage clinical trial presented at the American Urological Association’s annual meeting in Washington.

The phase-3 “Study ‘147” of Xgeva (denosumab) showed that men taking the drug survived for four months longer without the cancer spreading to their bones, compared with those taking placebo.

THOUSAND OAKS, Calif. — German drug maker Boehringer Ingelheim will purchase a manufacturing plant from U.S. biotech company Amgen, the two said.

The plant, located in Fremont, Calif., is 100,000 sq. ft. and employs around 360 people. BI has been a contract manufacturer for Amgen for more than 10 years. Financial terms of the deal were not disclosed, though BI said it would purchase “substantially all” of the assets at the plant.

THOUSAND OAKS, Calif. — A drug made by Amgen was able to delay certain bone problems in patients with advanced breast cancer better than a competing drug, according to study results presented at the 33rd annual San Antonio Breast Cancer Symposium.

Amgen said Xgeva (denosumab) was able to delay weakness and fracturing resulting from the cancer spreading to the bones five months longer than Novartis’ Zometa (zoledronic acid).

The Food and Drug Administration approved Xgeva on Nov. 18.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients whose cancer has spread to the bone.

The FDA announced Friday the approval of Thousand Oaks, Calif.-based biotech company Amgen’s Xgeva (denosumab) for bone metastases.

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

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.