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Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results

Delveinsight

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device.

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Could GLP-1 receptor agonists treat addiction and dementia?

Drug Discovery World

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. GLP-1 is a hormone that is produced naturally in the brain and the gut in response to food ingestion.

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Can you get melatonin over the counter in the UK?

Druggist

Melatonin is a hormone that is released at night by the pineal gland located in the brain. In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. Slenyto tablets have a specific licensed use. Is melatonin effective sleep aid medicine?

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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

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell [i]. by blinded independent central review. with a DoR range of 2.6-35.8+

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Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

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RhoVac’s Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA

The Pharma Data

. More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers. The drug candidate is currently engaged in a phase IIb clinical trial in prostate cancer, a study that aims to recruit more than 175 patients and that involves centres both in Europe and in the US.

Drugs 40
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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

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. WAKIX may reduce the effectiveness of hormonal contraceptives. Adverse Reactions. Use in Specific Populations.