Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

In two head-to-head clinical trials, patients on Beovu (brolucizumab) achieved vision gains that were non-inferior to aflibercept at year one with longer treatment intervals in a majority of patients[1],[2]  Beovu demonstrated greater reductions in central subfield thickness (CST, a key indicator of fluid in the retina) as early as week 16 and at one year

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Duvelisib Gains FDA Orphan Drug Designation for T-Cell Lymphomas

The FDA has granted duvelisib (Copiktra) with an orphan drug designation for the treatment of patients with T-cell lymphoma, according to a press release from Verastem Oncology, the company developing duvelisib.1 The PI3K-δ,γ inhibitor demonstrated efficacy in a phase I study and is currently being investigated in the phase II PRIMO trial (NCT03372057). “Receiving orphan

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Multiple myeloma treatment granted FDA Orphan Drug Designation

Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Glenmark Pharmaceuticals’ bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies. “Patients who are struggling with diseases like

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Novartis’ Phase III studies of ofatumumab achieve primary goals in relapsing multiple sclerosis

Novartis has reported positive findings from the Phase III ASCLEPIOS I and II clinical trials of ofatumumab (OMB157), which met their primary endpoints in relapsing forms of multiple sclerosis (RMS) patients. Ofatumumab is an anti-CD20 monoclonal antibody (mAb) designed to cause B-cell lysis and depletion. It has been formulated for once-monthly, subcutaneous self-administration. The identical

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Immunotherapy for Pediatric Solid Tumors: What’s the Latest?

Immunotherapy can be effective in treating certain types of pediatric blood cancers, but researchers are still exploring how this type of treatment could work for pediatric solid tumors. In clinical trials, scientists are combining immunotherapy agents in an effort to jump-start the immune system against pediatric solid tumors. Source DANA-FARBER Cancer Institute New treatments that

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Sarepta Duchenne drug rejected by FDA in surprise setback

In an unexpected decision, the Food and Drug Administration rejected Sarepta Therapeutics’ experimental drug for Duchenne muscular dystrophy, issuing on Monday a Complete Response Letter to the rare disease biotech.  According to Sarepta, the agency cited in its refusal infection risk tied to the drug’s delivery as well as preclinical signs of kidney toxicity. Called

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FDA approves entrectinib which targets a key genetic driver of cancer, rather than a specific type of tumour

The U.S. Food and Drug Administration (FDA) today granted accelerated approval to entrectinib, a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. “We are in an exciting era of innovation in cancer treatment as we

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