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- Read more about Astrazeneca’s Benralizumab phase III trials show positive results in severe asthma
Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.
- Read more about Amgen acquire global development and commercial rights from Boehringer Ingelheim for investigational BiTE immuno-oncology drug
Amgen and Boehringer Ingelheim announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836909 (AMG 420), a bispecific T cell engager (BiTE^®) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma. BI 836909 (AMG 420) is currently in Phase 1 studies. BI 836909 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the company was acquired by Amgen in 2012.
- Read more about MiMedx introduce placental collagen matrix product, AmnioFill in US market
MiMedx Group, Inc., the leading regenerative medicine company, announced its plans for the nationwide launch of AmnioFill, the first product in the MiMedx placental collagen matrix product family to be commercially launched.
- 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.