October 25, 2021

Phase III monarchE trial of Verzenio in breast cancer published in Annals of Oncology – Eli Lilly

Eli Lilly announced updated data from the positive Phase III monarchE trial evaluating the investigational use of Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC). As previously published in the Journal of Clinical Oncology, monarchE met its […]

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October 24, 2021

Janssen submits application seeking FDA approval of Stelara for the treatment of pediatric patients with juvenile psoriatic arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA). The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and […]

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October 23, 2021

Oyster Point Pharma announces FDA approval of Tyrvaya nasal spray for the treatment of the signs and symptoms of dry eye disease

Oyster Point Pharma, Inc. announced that the FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Tyrvaya Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. Tyrvaya Nasal Spray is believed to bind to cholinergic receptors to activate the […]

admin Health 0 2 min read
October 20, 2021

Pfizer and BioNTech receive first FDA Emergency Use Authorization of a COVID-19 vaccine booster

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts […]

admin Health 0 1 min read
October 19, 2021

FDA approves Qulipta for prevention of migraine – AbbVie

The FDA has approved Qulipta (atogepant tablets), from AbbVie, for the preventive treatment of episodic migraine in adults. The approval of Qulipta was based on findings from the Phase III ADVANCE study, a Phase II/III efficacy, safety, and tolerability study, and a Phase III long-term safety study. In the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, 910 […]

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October 18, 2021

ViiV Healthcare submits extended approval request for tablet formulation of Triumeq for HIV to FDA

ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above […]

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October 17, 2021

FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022 and informed us that they currently are planning to hold an advisory committee […]

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October 16, 2021

FDA approves Tavneos for vasculitis – ChemoCentryx

ChemoCentryx announced that the FDA has approved Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. […]

admin Health 0 1 min read
October 14, 2021

Hugo Robotic-Assisted Surgery System receives European CE Mark approval – Medtronic

Medtronic plc announced it has received CE (Conformité Européenne) Mark for the Hugo robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval is for urologic and gynecologic procedures, which make up about half of all robotic procedures performed today. The Hugo RAS system was designed to address the historic cost and utilization barriers that […]

admin Health 0 1 min read
October 13, 2021

CHMP recommends Artesunate Amivas for the initial treatment of severe malaria – Amivas

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Artesunate Amivas, intended for initial treatment of severe malaria in adults and children. The applicant for this medicinal product is Amivas Ireland Ltd. Artesunate Amivas will be available as 110 mg powder and solvent for solution […]

admin Health 0 36 sec read

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