Health Canada approves emicizumab

Print Friendly, PDF & Email


Emicizumab (Hemlibra)
Photo from Business Wire
Health Canada has approved emicizumab (Hemlibra®) for use as routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients with factor VIII inhibitors. Emicizumab is a bispecific factor IXa- and factor X-directed antibody. It bridges activated factor IX and factor X to restore the natural function of... [Read Article]
Print Friendly, PDF & Email

CHMP recommends generic deferiprone

Print Friendly, PDF & Email


Micrograph showing thalassemia
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Deferiprone Lipomed to treat iron overload in patients with thalassemia major. Deferiprone Lipomed is a generic version of the iron chelating agent Ferriprox, which has been authorized in the European Union since August 1999. According to... [Read Article]
Print Friendly, PDF & Email

CHMP backs generic lenalidomide

Print Friendly, PDF & Email


Lenalidomide (Revlimid)
Photo courtesy of Celgene
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Lenalidomide Accord as a treatment for multiple myeloma (MM). Lenalidomide Accord is a generic version of Revlimid, which has been authorized in the European Union since June 2007. The CHMP said studies have... [Read Article]
Print Friendly, PDF & Email

CHMP recommends expanded approval for daratumumab

Print Friendly, PDF & Email


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). The CHMP is recommending approval for daratumumab in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of adults with newly diagnosed multiple myeloma (MM) who... [Read Article]
Print Friendly, PDF & Email

CHMP announces 2 opinions on blinatumomab

Print Friendly, PDF & Email


Vials of blinatumomab
powder and solution
Photo courtesy of Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has released 2 new opinions regarding blinatumomab (Blincyto). The CHMP recommended expanding the approved use of blinatumomab to include pediatric patients, but the committee also recommended against approving blinatumomab to treat patients with... [Read Article]
Print Friendly, PDF & Email

CHMP backs 2 biosimilar pegfilgrastim products

Print Friendly, PDF & Email


Neulasta Onpro Kit
Photo from Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 pegfilgrastim biosimilar candidates—Udenyca and Pelgraz. Both products have been deemed highly similar to the reference product, Neulasta, a growth-colony-stimulating factor intended to reduce the duration of neutropenia and the incidence of febrile... [Read Article]
Print Friendly, PDF & Email

CHMP recommends expanded approval for rivaroxaban

Print Friendly, PDF & Email


Prescription drugs
Photo courtesy of the CDC
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for rivaroxaban (Xarelto) 2.5 mg tablets. The recommendation is for rivaroxaban co-administered with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adults with coronary artery disease or symptomatic peripheral... [Read Article]
Print Friendly, PDF & Email

FDA approves drug for IDH1-mutated AML

Print Friendly, PDF & Email


Ivosidenib (Tibsovo®)
Photo courtesy of
Agios Pharmaceuticals
The US Food and Drug Administration (FDA) has granted full approval for the isocitrate dehydrogenase-1 (IDH1) inhibitor ivosidenib (Tibsovo®). The drug is approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) who have an IDH1 mutation, as detected by an FDA-approved test. Ivosidenib was approved... [Read Article]
Print Friendly, PDF & Email

Breakthrough drugs approved with less stringent criteria

Print Friendly, PDF & Email


Prescription drugs
Photo courtesy of the CDC
Clinical trials supporting the approval of drugs with breakthrough therapy designation do not meet the same standards as trials for non-breakthrough drugs, according to researchers. Between 2012 and 2017, the US Food and Drug Administration (FDA) approved 46 breakthrough therapeutics on the basis of 89 pivotal trials. Researchers... [Read Article]
Print Friendly, PDF & Email

Health Canada expands approval of obinutuzumab

Print Friendly, PDF & Email


Obinutuzumab (Gazyva)
Health Canada has expanded the approved use of obinutuzumab (Gazyva®). The anti-CD20 monoclonal antibody is now approved for use in combination with chemotherapy to treat patients with previously untreated follicular lymphoma (FL) that is advanced (stage II bulky, stage III, or stage IV). In patients who respond to this treatment, obinutuzumab monotherapy can... [Read Article]
Print Friendly, PDF & Email

Conflicts of interest among FDA advisers

Print Friendly, PDF & Email


Prescription drugs
Photo by Steven Harbour
An investigative report has unearthed potential conflicts of interest among physicians who serve on advisory panels for the US Food and Drug Administration (FDA). The investigation revealed that some FDA advisers are receiving significant post-hoc payments from the makers of drugs they reviewed. The investigation also uncovered relationships between... [Read Article]
Print Friendly, PDF & Email

CHMP recommends CAR T for ALL, DLBCL

Print Friendly, PDF & Email


Tisagenlecleucel (Kymriah)
Photo courtesy of Novartis
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of tisagenlecleucel (Kymriah®, formerly CTL019) for 2 indications. According to the CHMP, the chimeric antigen receptor (CAR) T-cell therapy should be approved to treat adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL)... [Read Article]
Print Friendly, PDF & Email