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Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union.

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EU panel recommends against nod for Puma drug

A European Medicines Agency panel recommended against approving Puma Biotechnology’s lead breast cancer drug, an outcome the U.S drugmaker signaled in January 2018.

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Lynparza Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer

AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

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FDA Grants Priority Review for Lanadelumab

Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).

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Beacon Names New Multi-Channel Marketing Director

Beacon Healthcare Communications named Amy Whitcomb as Director of Multi-Channel Marketing in response to growing client needs for integrated multi-channel marketing solutions to drive brand campaign performance.

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Soccer is basically medicine, some researchers argue

Compared to inactive people, recreational soccer players have lower cholesterol, blood pressure and resting heart rates as well as less fat mass, a research review suggests.

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Novartis Eyes 2019 for Launch of Investigational nAMD treatment

Novartis is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration. The Swiss-based company is planning to seek regulatory approval of the drug during 2018.

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Reported Side Effects Raise Concerns for Regeneron’s Eylea

Shares of Regeneron Pharmaceuticals fell slightly in after-hours trading Wednesday following reports by providing doctors of increased observations of known side effects from the blockbuster drug Eylea.

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Kite, Sangamo team up in cancer therapeutics deal potentially worth $3+ billion

Kite Pharma, a Gilead company, inked a worldwide collaboration deal with Sangamo Therapeutics to develop oncology therapeutics.

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Achillion Slashes Staff and Initiates Restructuring Following Termination of J&J Deal

Five months after Janssen ended a multi-billion dollar development deal with Achillion Pharmaceuticals for the hepatitis C treatment combination JNJ-4178, the Connecticut-based company is slashing staff and initiating an operational restructuring plan.

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


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