Bayer and Onyx’s Nexavar Receives European Regulatory Approval for Thyroid Cancer

The European Commission have given marketing authorisation to use Nexavar, oral multi-kinase inhibitor, to treat the most common form of thyroid cancer, expanding the approved uses for the drug. Nexavar, which has previously received regulatory approval for advanced kidney and liver cancers, has now been approved for the treatment of metastatic differentiated thyroid carcinoma (DTC)

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Teva’s Version of Neupogen Approved by FDA

The US FDA (Food and Drug Administration) have approved Teva Pharmaceutical Industries’ form of Amgen’s severe neutropenia therapy, Neupogen. The FDA have approved tbo-filgrastim, which Teva noted is the first new granulocyte colony-stimulating factor (G-CSF) to be backed by the US agency in over 10 years.  The drug is a copy of Neupogen (filgrastim), which

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Amgen Requests Biosimilars Clinical Trial Clarification

Amgen, the world’s largest biotechnology company, have replied to the US FDA’s recent draft advice on biosimilars, noting that certain “changes and additional clarity are needed.” In February, the US Food and Drug Administration (FDA) presented three initial draft guidance documents on the regulation of biosimilars.  In response to these documents, Amgen commented “we appreciate

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Amgen and Watson Pharmaceuticals Announce Cancer Biosimilars Agreement

Amgen, an US biotech major, is partnering with Watson Pharmaceuticals to develop and commercialise several oncology antibody biosimilars. The new partners commented that the partnership “reflects the shared belief that the development and commercialisation of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to

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Amgen has been boosted by the news that regulators in the European Union have given the green light to Xgeva for cancer-related fractures.

 Amgen has been boosted by the news that regulators in the European Union have given the green light to Xgeva for cancer-related fractures. Specifically, the European Commission has granted marketing authorisation for Xgeva (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumours. The Commission has also granted the

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