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Israel’s Aidoc gets third FDA nod for AI tools for radiologists

Israel’s Aidoc, which provides artificial intelligence tools for radiologists, said the U.S. Food and Drug Administration cleared the company’s product for triage of cervical spine fractures.

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Too much vitamin B6 and B12 tied to hip fractures in older women

Older women who take supplements with high doses of vitamins B6 and B12 may be more likely than their counterparts who do not to experience hip fractures, a U.S. study suggests.

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Amgen sets $21,900 annual price for new Evenity bone drug

Amgen Inc. set the U.S. list price for the company’s new Evenity osteoporosis drug at $1,825 a month, or $21,900 for a full 12-month course of injections.

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FDA Approves Evenity For Treating Osteoporosis In Postmenopausal Women At High Risk For Fracture

Amgen and UCB announced that the U.S. FDA approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

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Taking vitamin D supplements may not improve bone health

Vitamin D supplementation may not improve bone density or prevent fractures and falls in adults, a large new analysis suggests.

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Amgen, UCB Resubmit Biologics License Application For Evenity To U.S. FDA

Amgen and UCB announced the resubmission of the Biologics License Application to the U.S. FDA for Evenity (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

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U.S. Supreme Court to hear Merck appeal over Fosamax suits

The U.S. Supreme Court agreed to hear Merck & Co.’s appeal of a lower court’s ruling that revived hundreds of lawsuits accusing the company of failing to adequately warn patients of the risks of thigh bone fractures associated with its osteoporosis drug Fosamax.

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Supplements may not lower fracture risk

Older adults who take vitamin D and calcium are no less likely to break their hips or other bones than peers who do not use these supplements per a research review.

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Safety Issues Force the FDA to Turn Down Amgen, UCB’s Osteoporosis Drug

The U.S. Food and Drug Administration rejected Amgen’s and UCB’s Biologics License Application for Evenity (romosozumab) for postmenopausal women with osteoporosis.

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Merck scraps development of osteoporosis drug

Merck & Co. Inc. said it would stop developing its experimental osteoporosis drug after an independent analysis confirmed the treatment raises the risk of stroke.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!


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