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Novartis’ Kisqali Effective in Postmenopausal Women with Breast Cancer

Novartis’ Phase III MONALEESA-3 clinical trial of Kisqali (ribociclib) hit the key secondary endpoint, overall survival.

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European Commission Approves Talzenna for Patients with Inherited BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

The European Commission approved Pfizer Inc.’s Talzenna (talazoparib), an oral polypolymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.

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FDA Approves Amgen and Allergan’s Kanjinti

Amgen Inc. and Allergan plc announced that the U.S. FDA approved Kanjinti (trastuzumab-anns) for all approved cancer indications of the reference product Herceptin.

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Novartis hopes Kisqali data will help narrow gap to blockbuster rival

Novartis released data showing sharply improved overall survival rates for the breast cancer drug Kisqali, which the Swiss drugmaker hopes will help it chip away at the dominance of Pfizer’s blockbuster Ibrance.

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Puma’s Nerlynx Edges Out Novartis’ Tykerb in Breast Cancer Trial

Puma Biotechnology’s Nerlynx (neratinib), in combination with Roche’s chemotherapy drug Xeloda (capecitabine), showed a treatment advantage compared to Novartis’ Tykerb (lapatinib) and Xeloda in a Phase III breast cancer study.

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AstraZeneca-Daiichi breast cancer treatment shows promise in latest study

An experimental breast cancer drug being developed by British drugmaker AstraZeneca and Japan’s Daiichi Sankyo’s met the main goal in a mid-stage study, bolstering the companies’ position in a highly competitive oncology market.

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U.S. FDA Approves Ibrance for Treatment of Men with HR+, HER2- Metastatic Breast Cancer

Pfizer announced that the U.S. Food and Drug Administration approved a supplemental New Drug Application to expand the indications for Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

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Novartis Receives Positive CHMP Opinion To Expand Kisqali Breast Cancer Combination Therapy

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent, superior and sustained efficacy compared to endocrine therapy alone.

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Trevana, Merrimack Announce Big Job Cuts in Quarterly Reports

In the wake of a Complete Response Letter issued by the U.S. FDA, Trevana Inc. is slashing one-third of the company’s workforce. Merrimack Pharmaceuticals Inc. is undertaking a corporate restructuring that included the reduction of 60 percent workforce.

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