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  • ARIAD Pharmaceuticals, Inc. announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib.

  • Biologists from Bochum and Bonn have detected a cannabinoid receptor in spermatozoa. Endogenous cannabinoids that occur in both the male and the female genital tract activate the spermatozoa: they trigger the so-called acrosome reaction, during which the spermatozoon releases digestive enzymes and loses the cap on the anterior half of its head. Without this reaction, spermatozoa cannot penetrate the ovum. The researchers published their findings in Scientific Reports.

  • Healthy fat tissue is essential for extended survival in the event of tumor-induced wasting syndrome (cachexia). In Nature Medicine, researchers at Helmholtz Zentrum München show that selective manipulation of an enzyme can stop unwanted metabolic processes.

  • The Union Minister for Chemicals & Fertilizers and Parliamentary Affairs Sh. Ananth Kumar has said that Promotion and Regulation should go hand in hand for medical devices sector to provide affordable health care to the poor. Speaking at the 9th Medical Technology Conference in New Delhi today he said that regulation is required in the medical devices sector to check profit and money making so as to facilitate providing adequate medical facilities to the poor.

  • Genmab A/S announced  that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab.

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  • Santhera Pharmaceuticals announces that the Office of Orphan Products Development (OOPD) at the US Food and Drug Admin-istration (FDA) has granted Santhera an award of USD 246,000 in support of its ongoing Phase I trial with omigapil (CALLISTO) in patients with congenital muscular dystrophy (CMD). Santhera is conducting CALLISTO in collaboration with the US National Institutes of Health (NIH). The FDA awards grants through the Orphan Products Grants Program to sup-port the clinical development of products for use in rare diseases where no current therapy exists.

  • Oragenics announced that it has received feedback from the U.S. Food and Drug Administration (FDA) in response to the Company’s request for a Type C meeting, concerning Phase 2 study protocols for the Company’s OM therapeutic candidate, AG013. As part of the clinical protocol for the study, Oragenics expects to file the Investigational New Drug (IND) update in late 2016 and initiate the study with AG013 in the United States and Europe during early 2017.

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