Pharma News

Patients suffering from chronic myeloid leukemia (CML) a rare form of cancer  can get huge financial benefits if they start using the generic form of drug Gleevec, the patent of which expired in January this year, a study said.

Scientists have developed a new method for harvesting stem cells, which is less invasive and reduces side effects for donors.The new method eliminates the need for the patient to take growth factor injections to increase cell numbers before a transplant.

Baxter International Inc. announced enrollment of the first patient in a US clinical trial for VIVIA, an investigational home haemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.

Novimmune, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy. NI-0501 is a fully human, anti-interferon-gamma (IFNγ) monoclonal antibody discovered and developed by Novimmune.

Takeda Pharmaceutical Company Limited and Frazier Healthcare Partners announced the formation of Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gynaecologic diseases and disorders.

Aralez Pharmaceuticals Inc. announced that it has resubmitted to the U.S. Food and Drug Administration ("FDA") the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™ (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

ResApp Health Limited , announced a positive outcome from its recent Pre-Submission Meeting with the United States Food and Drug Administration (FDA) regarding ResApp’s diagnostic mobile software application, ResAppDx.

Aeglea BioTherapeutics, Inc., announced the U.S. Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for AEB1102 for the treatment of Arginase I deficiency, a urea cycle disorder that results in elevated levels of the amino acid arginine, which can lead to a range of complications including intellectual disability and spasticity.

Celator Pharmaceuticals, Inc. announced positive results from the Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint demonstrating a statistically significant improvement in overall survival.  Data will be submitted for presentation at the American Society of Clinical Oncology 2016 Annual Meeting.

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Genentech, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.