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Pharmacy

CHMP recommends authorization of antiemetic agent

HT Staff Read Article
Published: 02/27/17

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Cancer patient
receiving chemotherapy
Photo by Rhoda Baer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the antiemetic agent rolapitant (Varuby) as a treatment for adults with cancer. The drug is intended to be used in combination with other antiemetic agents to prevent delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. [Read Article]

CHMP advocates approval of edoxaban product

HT Staff Read Article
Published: 02/26/17

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Thrombus
Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Roteas receive marketing authorization for the same indications as Lixiana. Both Roteas and Lixiana are oral factor Xa inhibitors that contain the active ingredient edoxaban. The CHMP has recommended approving Roteas for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults. [Read Article]

CHMP recommends new indication for daratumumab

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Published: 02/25/17

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Daratumumab (Darzalex)
Photo courtesy of Janssen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorization for daratumumab (Darzalex®) in the European Union. The CHMP recommended approving daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone as treatment for adults with multiple myeloma (MM) who have received at least 1 prior therapy.  [Read Article]

Drug granted orphan status for follicular lymphoma

HT Staff Read Article
Published: 02/24/17

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Micrograph showing
follicular lymphoma

The US Food and Drug Administration (FDA) has granted orphan designation to G100 for the treatment of follicular lymphoma. G100 is a synthetic small-molecule toll-like receptor-4 agonist, glucopyranosyl lipid A, formulated in a stable emulsion. The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US. [Read Article]

FDA expands approved indication for lenalidomide

HT Staff Read Article
Published: 02/23/17

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Lenalidomide (Revlimid)
Photo courtesy of Celgene

The US Food and Drug Administration (FDA) has approved a new indication for lenalidomide (Revlimid). The drug is now approved for use as maintenance therapy after autologous hematopoietic stem cell transplant (auto-HSCT) in patients with multiple myeloma (MM). The expanded indication makes lenalidomide the first treatment to receive FDA approval for maintenance following auto-HSCT. [Read Article]

 

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