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Puma Biotechnology declares results of Phase II ‘basket’ Clinical Trial
Phase II ‘basket’ clinical trial of PB272 (neratinib) in patients with tumors harboring HER2 or HER3 mutations results were declared by Puma Biotechnology as published in the journal…
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SkylineDx collaborates with Mayo Clinic to curate Diagnostic tests for Melanoma
SkylineDX affirmed foraying into a strategic collaboration to curate novel diagnostic tests to enhance clinical decision making for melanoma patients. The Joint development agreement…
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Novartis declares results of ELIANA Clinical Trial of kymriah
Novartis declared results from ELIANA Clinical Trial of kymriah in refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia. Kymriah claimed to become one…
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Upsher-Smith sought FDA approval for Bumetanide Tablets
Upsher-Smith Laboratories, LLC declared that it sought U.S Food and Drug Administration's approval for new drug application (ANDA) for Bumetanide Tablets, USP, 0.5 mg, 1 mg, and 2 mg,…
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MedShape declares successful performance of first surgeries using DynaNail XL
Industry leader in orthopaedic devices using advanced functional materials, MedShape declared successful performance of first surgeries using DynaNail XL TTC Fusion System. The…
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Mallinckrodt enrolls first patient in Phase 4 Trial of H.P Acthar Gel
Mallinckrodt plc affirmed enrolling first patient in the company's Phase 4, multi center, randomized, double-blind, placebo-controlled pilot study to facilitate evaluation of the…
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U.S FDA grants Fast Track designation to Takeda’s TAK-426
Takeda Pharmaceutical company Limited asserted that the U.S Food and Drug Administration has extended Fast Track designation to TAK-426 i.e Takeda's Zika virus vaccine candidate. …
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CutisPharma confirms FDA’s sanction of FIRVANQ for Clostridium difficile
U.S FDA has sanctioned CutisPharma's FIRVANQ (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by …
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FDA extends 510(K) clearance for electroCore’s gammaCore (nVNS)
electroCore sought 510(k) clearance from the U.S Food and Drug Administration for an extended label for gammaCore (nVNS) as an acute treatment of pain associated with migraine in adult…
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Letco Medical and ARL Bio Pharma roll out Quality Savings Program
Supplier of quality compounding products, supplies and equipment, Letco Medical along with ARL Bio Pharma collaborate to roll out their joint Quality Savings Program. The program…
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Prometic Life Sciences declares outcome of FDA meet for PBI-4050
Clinical development Type C meeting with the US Food and Drug Administration (FDA) for its orally active anti-fibrotic lead drug candidate, PBI-4050 was declared by Prometic Life…
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NJ Bariatric Center welomes new participants for Low BMI Weight Loss surgery Study
In a bid to bring on board fresh participants for its weight loss surgery surgery thus making it accessible patients with a considerably low BMI of 30-35, New Jersey Bariatric Center…
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Aradigm sought CRL from FDA pertaining to NDA for Linhaliq treating NCFBE patients
Aradigm Corporation asserted that it received a Complete Response Letter from the US Food and Drug Administration regarding its New Drug Application (NDA) for Linhaliq for treating …
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Araclon Biotech partners with TFS International to advance AD vaccine ABvac40 into Phase II
TFS International and Arclon Biotech decided to continue their partnership with TFS advancing their Alzheimer's disease vaccine ABvac40 into phase II. AD is a progressive disease…
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IRIS appoints Chris Belmont as interim CEO, revamps leadership Team
Intelligent Retinal Imaging Systems (IRIS), asserted the appointment of Chris Belmont as interim CEO effective immediately. IRIS also named Steve Martin as Chief Commercial Officer and…
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Sterling Pharma Solutions surges visibility in Japan
Sterling Pharma Solutions witnessed growth in the Japanese market owing to its technical capabilities and innovation strategy. Sterling's technology and innovation strategy, which has…
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Solid Form Solutions obtained by Avista Pharma Solutions
Avista Pharma Solutions completed acquisition of Solid Form Solutions located in Edinburgh, Scotland. Solid Form Solutions provider of solid state chemistry and crystallization…
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REGENXBIO forays into Strategic Partnership with FUJIFILM Diosynth Biotechnologies
Leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform, REGENXBIO, forays…
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Novartis proclaimed FDA approval of NDA for Lutathera
Advanced Accelerator Applications which is a subsidiary of Novartis Groupe S.A sought U.S Food and Drug administration's assent for its New drug application (NDA) for Lutathera …
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Novartis ventures into Licensing agreement with Spark Therapeutics
Novartis proclaimed a licensing agreement with Spark Therapeutics encompassing development, registration and commercialization rights to voretigene neparvovec in markets outside the US.…
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