Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis
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- Category: Novartis
Novartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis[1]. Data will be presented at a key medical congress in the second half of 2017.
FDA Advisory Committee votes in favor of Pfizer's MYLOTARG (gemtuzumab ozogamicin) for acute myeloid leukemia
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favorable risk:benefit profile for MYLOTARG (gemtuzumab ozogamicin) 3 mg/m2 on days 1, 4 and 7 added to chemotherapy for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML).
Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL
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- Category: Novartis
Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Amgen and QB3@953 announce winners of The Amgen Golden Ticket
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- Category: Amgen
Amgen (NASDAQ: AMGN) and QB3@953 today announced that Darmiyan and Enable Biosciences have won the Amgen Golden Ticket at QB3@953. Each company receives one year of lab space at the QB3@953 life sciences incubator, additional facility benefits and connections to Amgen's scientific and business leaders to help advance their scientific programs.
Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from HAVEN 1, a phase III study evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) in adults and adolescents with haemophilia A with inhibitors, were published in The New England Journal of Medicine (NEJM).
BESPONSA® approved in the EU for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced that the European Commission has approved BESPONSA® (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL.
Jardiance® (empagliflozin) analysis reinforces established safety profile
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- Category: Boehringer Ingelheim
An analysis of pooled safety data from 15 studies plus 4 extension studies involving more than 12,500 adults with type 2 diabetes demonstrated treatment with Jardiance® (empagliflozin) tablets (10 mg or 25 mg) was well tolerated, with no imbalance in lower limb amputations or bone fractures compared with placebo. The analysis, which includes the EMPA-REG OUTCOME® trial, was published this month in Advances in Therapy.(1)
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