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) Merck awards €1.25 million to research projects through its 2017 Grant for Fertility Innovation (GFI)
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- Category: Merck Group
Merck, a leading science and technology company, today announced its commitment to award €1.25 million to research projects in the field of fertility, supporting the advancement of medical science through the Grant for Fertility Innovation (GFI) in 2017. Launched as the first of the Merck Grants for Innovation in 2009, Merck's GFI is providing encouragement for innovation and support for scientists to realize projects that could potentially lead to the next breakthrough in the fertility treatment area. More Pharma News ...
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- Merck Foundation established
- The made-in-Italy fast-track acceleration program dedicated to projects in life science