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PeptiDream Bags R&D Pact With Bayer

Peptidream Inc. scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment of multiple disease targets.

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U.S. FDA Approves Kaléo’s AUVI-Q 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

Privately held pharmaceutical company kaléo announced that the U.S. Food and Drug Administration approved its supplemental New Drug Application for AUVI-Q (epinephrine injection, USP) 0.1 mg.

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Acorda Therapeutics scraps Parkinson’s drug after deaths

Acorda Therapeutics Inc. said the company would stop developing its Parkinson’s disease drug tozadenant less than a week after reporting deaths in key studies testing the treatment.

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Zejula approved in Europe for recurrent ovarian cancer

Tesaro Inc.’s PARP inhibitor Zejula was approved by the European Commission for recurrent ovarian cancer.

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New ARV drugs, early diagnosis key to beating AIDS epidemic: UNAIDS

Developing new antiretroviral (ARV) drugs and using technology for early diagnosis are among steps needed to sustain momentum in fighting HIV/AIDS and ending the disease as a public health threat by 2030, UNAIDS said in a report.

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Roche stock up $12 billion on cancer, hemophilia trials

Roche shares were lifted by two clinical trial wins for its new cancer and hemophilia drugs, potential blockbusters that the Swiss drugmaker is counting on to offset shrinking revenue from older medicines.

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Samsung Bioepis Receives Regulatory Approval for Europe’s First Trastuzumab Biosimilar, Ontruzant

Samsung Bioepis Co. Ltd. announced the European Commission’s marketing authorization of Ontruzant – a biosimilar referencing Herceptin (trastuzumab) – for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

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SEC Filing Reveals GlaxoSmithKline’s 13 Percent Stake in Spero Therapeutics

A filing with the U.S. Securities and Exchange Commission (SEC) indicates that the UK’s GlaxoSmithKline has a 13 percent stake in Spero Therapeutics, with 1,854,006 shares in the Massachusetts biotech company.

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FDA OKs Gazyva for new lymphoma indication

The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.

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Trump administration proposes Medicare rules aimed at opioids, drug costs

The Trump administration proposed changes to Medicare drug plans including limits on opioid prescriptions and rules aimed at reducing drug costs for seniors, such as requiring health insurers to pass on discounts to consumers.

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December 2018 Focus: Healthcare Agency Roundtable, Mobile Marketing, and more!


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