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  • Sreoshi Chatterjee
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Neurocrine Biosciences files NDA for opicapone for Parkinson’s disease

Feb 15, 2018
Neurocrine Biosciences announced that the US FDA has provided assistance on the regulatory path forward to support the New Drug Application for opicapone, an investigational drug for…
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Sandoz asserts FDA’s approval for initiation of Glatopa

Feb 15, 2018
Novartis division, Sandoz asserted that the US FDA ha sanctioned the roll out and launch of Glatopa (glatiramer acetate injection) 40 mg/mL. Glatopa was developed under a…
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FDA clearance sought for Roche’s Factor II and Factor V test on cobas 4800 system

Feb 15, 2018
Roche asserted that it has received FDA clearance for the cobas Factor II and Factor V Test for use on the cobas 4800 system. The test enables laboratories to simultaneously evaluate …
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FDA sanctions breakthrough treatment for specific kind of Prostate Cancer

Feb 15, 2018
FDA has approved a certain Erleada for the treatment of patient inflicted with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with…
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J&J Pharmaceuticals announce approval of ERLEADA by FDA for NM-CRPC patients

Feb 15, 2018
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the approval of ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of…
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Mallinckrodt affirms enlisting of first patient for ExpressGraft C9T1 Phase 1 Study

Feb 15, 2018
Mallinckrodt plc  confirmed the enrollment of first patient for the company's Phase 1 study evaluating the safety and tolerance of ExpressGraft C9T1 skin tissue in the treatment of…
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FDA accepts Ortho Dermatologics JEMDEL for Plaque Psoriasis Treatment

Feb 15, 2018
Division of Valeant Pharmaceuticals International, Inc., Ortho Dermatologics asserted that the U.S Food and Drug Administration accepted the New Drug Application for JEMDEL  …
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PharmaMar signs licensing agreement with Seattle Genetics

Feb 15, 2018
PharmaMar forays into an exclusive licensing agreement with Seattle Genetics ensuring access to certain PharmaMar proprietary molecules for the development and commercialization of…
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Amgen’s BLINCYTO sBLA to be assessed by FDA for treating MRD

Feb 15, 2018
Amgen asserted that the Oncologic Drugs Advisory Committee of the U.S Food and Drug Administration will assess the data supporting the BLINCYTO supplemental Biologics License…
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Dr. Christine Esau appointed VP of Research and Development for Arcturus Therapeutics

Feb 14, 2018
Ace RNA medicines company, Arcturus Therapeutics asserted the appointment of Dr. Christine Esau, Senior Director of Translational Research, as Vice President of Research and…
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