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Oklahoma sues opioid drugmakers; New Hampshire presses epidemic probe

Oklahoma joined growing litigation over claims drugmakers misrepresented the risks of opioid painkillers, as New Hampshire cleared a hurdle in its own probe of the role played by companies in the national addiction epidemic.

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FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).

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BioMarin Submits Pegvaliase Biologics License Application to the U.S. FDA for Treatment of Phenylketonuria

BioMarin Pharmaceutical Inc. announced that the company submitted a Biologics License Application on June 30, 2017 to the U.S. Food and Drug Administration for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.

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Roche buys diabetes app firm

Roche bought Vienna-based diabetes management platform mySugr, joining a crowd of companies expanding app-based digital health services.

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Pfizer’s Besponsa Approved in EU

The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

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Shire to Consolidate 3,000+ Jobs Over 4 Years to 2 Massachusetts Sites

Dublin, Ireland-based Shire plans to consolidate more than 3,000 staffers spread out at over half-a-dozen locations across Massachusetts to two campuses in Cambridge and Lexington.

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7 determining approaches for picking the perfect service

Presently, if to think about the broad choice of the ventures, it is not complicated to confuse. All the online services possess various odds and it is not easy to decide on one Alternative data-warehousing system. As it happens, we passed a resolution to give you approaches about the details which you are bound to […]

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FDA Approves Vectibix For Use In Wild-Type RAS Metastatic Colorectal Cancer

Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.

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Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)

Acorda Therapeutics Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for Inbrija (CVT-301, levodopa inhalation powder). Acorda is developing Inbrija as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa/levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, Inbrija, has been conditionally accepted by the FDA.

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First Scientifically Validated Symptom Checker with Artificial Intelligence Launches in the United States

Mediktor, a European health technology company, announced the U.S. launch of the first scientifically validated health checker based on artificial intelligence.

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