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BioNews Capsule: Ready-to-drink Colonoscopy Prep, Viagra Connect, ZYNE's STARS

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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, 2018. Mavenclad was granted approval in the European Union in August of this year. It is not approved in the U.S. yet.

Shares of Zynerba Pharmaceuticals Inc. (ZYNE) are up more than 6% in pre-market trading on Monday, following new data from phase II studies of ZYN002 in patients with focal seizures, dubbed STAR 1 and STAR 2.

Patients who received ZYN002 (195mg during STAR 1 for three months and 390mg for six months in STAR 2) for a total of nine months achieved a median reduction in seizures of 65%. Patients who received ZYN002 (390mg for three months in STAR 1 and six months in STAR 2) achieved a 48% median reduction in seizures from baseline, according to the Company.

Baylor University Medical Center in Dallas has reported the first case of a baby to be born as a result of a womb transplant in the U.S. According to reports, the woman who had been born without a uterus had received a transplanted uterus last September.
The details of the mother and baby are kept under wraps to protect their privacy.

by RTT Staff Writer

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