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FDA Approves Herceptin Biosimilar Herzuma

Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab).

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Generon Presents Positive Phase III Results Of F-627 In Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Generon BioMed Holding Ltd. announced at the annual San Antonio Breast Cancer Symposium (SABCS) positive results from a placebo-controlled trial with F-627, a recombinant human Granulocyte Colony Stimulating Factor protein, designed using Generon’s Dikine technology platform.

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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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Roche’s Tecentriq wins fast FDA review in tough-to-treat breast cancer

Roche’s Tecentriq will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, seeking to be the first company to have an immunotherapy win approval in this indication.

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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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Roche scores clinical trial win in slowing aggressive type of breast cancer

An immunotherapy cocktail from Roche helped slow an aggressive type of breast cancer where new treatments have proven elusive.

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FDA approves Pfizer’s breast cancer drug Talzenna

The U.S. Food and Drug Administration approved Pfizer Inc.’s Talzenna (talazoparib) for an advanced form of breast cancer.

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FDA Lifts Partial Clinical Hold for Mersana’s XMT-1522

Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.

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Novartis trial win lifts profile of new breast cancer drug

Novartis’ efforts to tackle an elusive gene mutation behind tough-to-treat breast cancer were rewarded as the Swiss drugmaker said one of its investigational medicines slowed disease progression.

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Breast Cancer Device Receives FDA Approval

The U.S. Food and Drug Administration approved the first non-radioactive, dual-tracer for sentinel lymph node biopsy.

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


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