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Yearly Archives: 2019

Enzalutamide Approved by FDA for metastatic castration-sensitive prostate cancer (mCSPC) Treatment

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Dec 17, 2019: Pfizer Inc. and Astellas Pharma Inc.recieves the FDA approved (first and only oral treatment) supplemental new drug application for enzalutamide (Xtandi)...

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

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Dec 17, 2019: AstraZeneca and MSD announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5...

Takeda collaborates with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

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Dec 14, 2019: Takeda and MiTest Health LLC a pioneering health technology company, announced an exclusive partnership to optimize MiTest’s personalized risk and outcome...

Horizon Therapeutics first FDA-approved medicine Teprotumumab for the Treatment of Thyroid Eye Disease (TED)

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Dec. 16, 2019: Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted collectively about the potential...

U.S. FDA Approved Avadel’s Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

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Dec. 16, 2019: Avadel Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug...

FDA approved Salarius’s Seclidemstat by Fast Track Designation for Lead Drug Candidate, in Relapsed or Refractory Ewing Sarcoma

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Dec. 16, 2019: Salarius Pharmaceuticals announced that its lead investigational drug candidate, Seclidemstat(a potent reversible LSD1 inhibitor), has been granted Fast Track Designation by...

AstraZeneca completed an Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia

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Dec 16, 2019: AstraZeneca has completed an agreement with Cheplapharm Arzneimittel GmbH (Cheplapharm) to deprive its commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine...

Soligenix initiates phase 1C, double-blind, placebo-controlled, phase 1C trial of RiVax, a lyophilized ricin toxin A-chain subunit vaccine with alum-adjuvant

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Dec 14, 2019 : Soligenix announced that it has opened the study titled "A phase 1C, double-blind, placebo-controlled, randomised study to evaluate the safety...

ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir DTG 50mg film-coated tablet (FCT) in paediatric HIV...

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Dec 13, 2019: ViiV Healthcare announced that it has made regulatory submissions to both the European Medicines Agency (EMA) and the U.S. Food and Drug...

FDA Approved Amarin’s Vascepa For the cardiovascular problems, Shares Up 5%

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Dec 13, 2019: Shares of Amarin Corp. jumped 5% on the extended trading session after the company said, it received approval to market its...

Trastuzumab deruxtecan (DS-8201), accomplished the tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

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Dec 11, 2019: AstraZeneca and Daiichi Sankyo presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201),...

First Ever Randomized Phase 3 Clinical Trial (LIBRETTO-431) for the Treatment of Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

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Dec. 11, 2019: Eli Lilly and Company today announced the opening of the LIBRETTO-431 clinical trial for selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small...
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