Ready-to-drink Colonoscopy Prep, Viagra Connect, ZYNE’s STARS

Today’s BioNews Capsule brings you news about the only FDA-approved prescription colonoscopy prep that comes “ready-to-drink; a comprehensive companion diagnostic test for solid tumors; reclassification of Viagra, Zynerba’s focal seizures trials and the first case of a baby to be born as a result of a womb transplant in the U.S.

Read on…

The FDA has approved Ferring Pharmaceuticals Inc.’s CLENPIQ oral solution for cleansing of the colon in adults undergoing a colonoscopy. CLENPIQ that comes “ready-to-drink” is expected to be available in the first quarter of 2018.

Colonoscopy screening is said to reduce colorectal cancer incidence and mortality, according to the U.S. Center for Disease Control and Prevention.

The FDA has approved FoundationOne CDx, a comprehensive companion diagnostic assay for personalised oncology care.

FoundationOne CDx helps physicians in clinical decision-making by providing a report that describes the unique genomic profile of the patient’s tumor as well as associated approved therapies and relevant clinical trial information.

FoundationOne CDx is developed by Foundation Medicine Inc. (FMI), and is the first and only FDA-approved test of its kind for all solid tumors.

Pfizer Inc.’s (PFE) erectile dysfunction drug Viagra has been reclassified from Prescription Only Medicine (POM) to Pharmacy (P) status in the UK by the Medicines and Healthcare products Regulatory Agency.

This version of Viagra known as Viagra Connect is expected to be launched in the spring of 2018, and will be available in retail stores such as supermarkets and newsagents.

Viagra will remain available as a prescription medicine also.

Germany’s Merck KGaA has won approval for Mavenclad as monotherapy in Canada for the treatment of adult patients with relapsing-remitting multiple sclerosis.

Mavenclad is administered in just two short annual courses of tablets with a maximum of 20 days of treatment over two years.

The drug is expected to be available in Canada in early January,…

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