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- Read more about FDA Conditionally Accept Neurocrine’s Proprietary Name INGREZZA for VMAT2 Inhibitor Valbenazine
Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine. The Company has recently announced the submission of a New Drug Application (NDA) with the FDA for valbenazine in tardive dyskinesia and is also exploring its utility in Tourette syndrome.

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5 September 2016

Cipla gets final US FDA approval for generic Enablex tablets

Cipla has received final approval for its ANDA for darifenacin extended-release tablets, 7.5mg and 15mg, from the US FDA.
- Read more about Biogen’s aducanumab get Fast Track designation by U.S.FDA
Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.
- Read more about Sensorion receive FDA Approval to Initiate a Clinical Study of SENS-111
Sensorion announces that it has obtained Investigational New Drug (IND) status from the FDA for SENS-111, enabling the Company to initiate a clinical study in acute severe vertigo.
- Read more about Perrigo Get Tentative Approval from FDA For Generic Version Of Epiduo® Gel
Perrigo Company plc announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%).
- Read more about Neurocrine seeks US FDA approval for valbenazine to treat tardive dyskinesia
Neurocrine Biosciences, Inc. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for once-daily dosing of valbenazine in treating tardive dyskinesia.
- Read more about ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA
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.
- Read more about Cannabinoid receptor activates spermatozoa
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.
- Read more about 30-day mortality following chemotherapy for breast and lung cancer : Study Says
For the first time, national data on 30-day mortality for patients with breast and lung cancer treated with chemotherapy have been collected and analysed in order to help clinical teams review and improve patient care, and identify groups of patients who may have additional needs.
- Read more about Molecularly shutting down cancer cachexia
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.