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Pear Therapeutics Announces FDA Submission for Somryst

Pear Therapeutics announced the filing of a submission to the U.S. Food and Drug Administration seeking marketing authorization for Somryst, a prescription digital therapeutic (PDT) intended for use in the treatment of adults with chronic insomnia and depression.

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Gilead Appoints Christi L. Shaw as Chief Executive Officer of Kite

Gilead Sciences Inc. announced that Christi L. Shaw will join the company as CEO of subsidiary Kite Pharma and will become a member of Gilead’s senior leadership team.

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Gilead Sciences and Renown Institute for Health Innovation Announce Strategic Collaboration to Advance Understanding of Nonalcoholic Steatohepatitis

Gilead Sciences Inc. and the Renown Institute for Health Innovation announced a strategic collaboration to collect and analyze genetic and electronic health data that can enhance the understanding of nonalcoholic steatohepatitis (NASH) and potentially inform development of treatment options for the disease.

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Celsius Therapeutics Signs Collaboration Agreement with Janssen to Identify Response Biomarkers for Ulcerative Colitis

Celsius Therapeutics, a company focused on the discovery and development of precision therapeutics for patients with autoimmune diseases and cancer, announced a collaboration with Janssen Biotech Inc.

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Foundation Medicine Expands Indication for FoundationOne CDx as a Companion Diagnostic for Lynparza

Foundation Medicine Inc. received approval from the U.S. Food and Drug Administration for FoundationOne CDx to be used as a companion diagnostic for Lynparza (olaparib) for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.

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Healthcare Marketing to Be Among the Hardest Hit by Third-party Cookie and Privacy Regulations

Klick Health published “Cookies Crumble as Privacy Rises,” an industry POV on upcoming changes to the ways marketers will be able to target, track, and engage with consumers online.

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FDA Approves Symdeko to Treat Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in CFTR Gene

The U.S. FDA approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to the Vertex Pharmaceuticals Inc. medicine.

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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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Columbia Care Announces Launch of Pioneering Research Study to Identify Genetic Factors Affecting the Efficacy and Safety of Medical Cannabis

Columbia Care Inc. announced the initiation of a research study designed to optimize the use of the company’s precisely manufactured, pharmaceutical-quality medical cannabis products through the identification of genetic factors affecting their safety and efficacy.

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New Klick Health Research: Google Assistant Recognizes Medication Names Better Than Alexa and Siri

Klick Health research found Google Assistant’s comprehension of the most commonly dispensed medication names in the U.S. was, on average, almost twice as accurate as Alexa and Siri’s.

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Extensive pharmaceutical business and marketing intelligence. For back issues, please contact

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


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