BMY's Opdivo At The Altar Again, MRK Gets FDA Nod, Watch Out For OASM

(RTTNews) - Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application, seeking expanded use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy has been granted priority review by the FDA - with a decision date set for March 2, 2017.

Opdivo, as a single agent or in combination with Yervoy, is already approved for a number of indications. The drug generated global sales of $942 million in 2015. Thanks to expanding indications, the drug's sales in the first half of 2016 are an impressive $1.54 billion.

Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). Blockading this pathway helps the body's immune system fight the cancer cells.

BMY closed Friday's trading at $50.02, down 0.68%.

The FDA has approved Merck's (MRK) ZINPLAVA Injection to reduce recurrence of Clostridium difficile infection, or CDI, in patients 18 years of age or older undergoing treatment with antibiotics for CDI and who are at high risk for CDI recurrence.

ZINPLAVA is not an antibacterial drug and is not indicated for the treatment of CDI. It should only be used in conjunction with antibacterial drug treatment of CDI. Merck anticipates making ZINPLAVA available in first quarter 2017.

In other news, Merck's phase III trial of approved drug KEYTRUDA in patients with previously treated advanced urothelial cancer has met the primary endpoint of overall survival.

In the trial, dubbed KEYNOTE-045, KEYTRUDA was superior compared to investigator choice chemotherapy. Given the encouraging data, an independent Data Monitoring Committee has recommended that the trial be stopped early.

KEYTRUDA is already indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

The sales of the drug for full year 2015 were $566 million, and were $563 million in the first half of this year.

MRK closed Friday's trading at $61.20, down 1.16%.

Italy-based Newron Pharmaceuticals S.p.A. (NWRN) is all set to face the FDA on March 21, 2017, thanks to the U.S. regulatory agency accepting the resubmitted Xadago NDA as a complete Class 2 response.

Xadago is being proposed as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson's disease.

Newron's Xadago was turned down by the FDA in March of this year, with the regulatory agency requesting potential effect of Xadago on behaviors relating to abuse liability and dependence/withdrawal effects as required by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the FDA.

The company resubmitted the Xadago NDA to the FDA last month.

Xadago has received marketing authorization for the treatment of Parkinson's disease in the European Union and Switzerland and is commercialized by Newron's Partner Zambon.

NWRN.SW closed Friday's trading at $20.75, up 5.33%.

Shares of Oasmia Pharmaceutical AB (OASM) rose over 4% on Friday on news that the company is in discussions concerning acquisition of a novel cancer project.

More details are expected to be released on Monday at the latest.

OASM closed Friday's trading at $2.70, up 4.25%.

Vascular Solutions Inc. (VASC) has received FDA clearance for its Fluent inflation device for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters.

Fluent received CE Mark clearance in August 2016 and has already begun international clinical evaluations. The commercial launch of Fluent in the U.S. and Europe is expected to commence during this quarter.

VASC closed Friday's trading at $46.77, down 0.04%.