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ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

pharmaphorum

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.

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FDA Warns About Compounded Versions of Ozempic and Wegovy

XTalks

Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating. GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. mg and 2.4

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Three trends in the antibody-drug conjugate (ADC) market 

Drug Discovery World

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours

The Pharma Data

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [vii]

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Enough Of Wasting Away From Cancer: Companies Gear Up To Tackle Cachexia

Delveinsight

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Apart from the products as mentioned earlier, Tetra Bio?Pharma, Cachexia is a complex metabolic syndrome, which is characterized by the loss of fat and muscles in the body.

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Surrogate Endpoints: How to Choose the Best One for Your Rare Disease Trial

XTalks

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. In the case of the former, pharmaceutical and biologics companies would be eligible for approval of their product through traditional regulatory pathways; the latter could support accelerated approval.

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