Osteonecrosis News and Research

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$Women with spine fractures can benefit from alendronate therapy$

Women with spine fractures can benefit from alendronate therapy

Continuing a popular but controversial treatment for osteoporosis could reduce spine fracture risk for a particular group of patients, but others could see little to no change if they discontinue it. Based on available evidence, a UCSF researcher reevaluated his 2006 finding from a randomized 10-year study of alendronate, a type of bisphosphonate - a class of drugs that prevent loss of bone mass.

10 May 2012

FDA issues Complete Response Letter to Amgen’s sBLA for XGEVA

Amgen today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

27 Apr 2012

Merck wins New Jersey FOSAMAX litigation

Merck, known outside the United States and Canada as MSD, today said a state court jury in New Jersey found in its favor in the Sessner v. Merck case, rejecting the claims of a woman who blamed her jaw-related problems on her FOSAMAX use.

19 Apr 2012

Maturitas publishes EMAS' clinical guide on SERMs against postmenopausal osteoporosis

Elsevier, a world-leading provider of scientific, technical and medical information products and services, announced today the publication of an important clinical guide from the European Menopause and Andropause Society (EMAS) in the February issue of Maturitas.

29 Feb 2012

Cartilage graft can stimulate bone regeneration

A person has a tumor removed from her femur. A soldier is struck by an improvised explosive device and loses a portion of his tibia. A child undergoes chemotherapy for osteosarcoma but part of the bone dies as a result.

14 Feb 2012

FDA panel votes against Amgen’s Xgeva in prostate cancer

An FDA panel of oncologists has voted against a new use for Amgen's Xgeva in prostate cancer on Wednesday, saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients. Xgeva is already approved to prevent fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.

9 Feb 2012

FDA reviews Amgen’s prostate cancer drug Xgeva

U.S. Food and Drug Administration (FDA) researchers say that an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side effects.

7 Feb 2012

New discovery paves way for genetic screening test

Researchers at the Columbia University College of Dental Medicine have identified a genetic variation that raises the risk of developing serious necrotic jaw bone lesions in patients who take bisphosphonates, a common class of osteoclastic inhibitors.

27 Jan 2012

FDA invites Amgen for ODAC meeting on XGEVA sBLA to treat castration-resistant prostate cancer

Amgen today announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

30 Dec 2011

Adjuvant zoledronic acid shows promise against ER-positive premenopausal breast cancer

Researchers have proven the continuing effectiveness of treating patients with estrogen receptor-positive premenopausal breast cancer with adjuvant zoledronic acid in addition to adjuvant endocrine treatment including ovarian function suppression.

8 Dec 2011

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011

Amgen's XGEVA delays onset of bone metastases in men with prostate cancer

Amgen announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer.

16 Nov 2011

Merck wins fourth FOSAMAX trial

Merck, known as MSD outside the United States and Canada, today said a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.

4 Oct 2011

Amgen's Prolia receives FDA approval for new indications to treat cancer patients

Amgen today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

19 Sep 2011

FDA reviews safety issues of bisphosphonates for osteoporosis

An advisory committee for U.S. Food and Drug Administration meets Friday to review the safety of a popular class of osteoporosis drugs called bisphosphonates amid worry that their long-term use could cause rare fractures of the thighbones and affect the jawbone. The committee will evaluate whether women should temporarily stop using the drugs or use them for only a few years.

6 Sep 2011

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

Amgen today announced that the European Commission (EC) has granted marketing authorization for XGEVA (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors.

15 Jul 2011

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

28 Jun 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

6 Jun 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011