Abbott Laboratories (ABT: Quote) is all set to collaborate with Janssen Biotech Inc. and Pharmacyclics Inc. (PCYC: Quote) on the development of a companion test for investigational leukemia therapy.
As per the terms of the collaboration agreement, Abbott will develop a FISH-based test to identify high-risk chronic lymphocytic leukemia patients who have a deletion within a specific chromosome and may respond to experimental drug Ibrutinib.
Ibrutinib is currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including chronic leukemia and lymphoma.
Alexza Pharmaceuticals Inc.'s (ALXA: Quote) inhaled antipsychotic therapy ADASUVE has been granted marketing authorization in the European Union.
In the European Union, ADASUVE, 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is authorized for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
ADASUVE is already approved in the U.S. However, authorization for ADASUVE in the EU differs from that in the U.S., with respect to indication, dose strengths, and risk mitigation and management plans.
ALXA closed Thursday's trading at $4.44, down 0.45%.
Pluristem Therapeutics Inc. (PSTI: Quote) on Thursday announced that the FDA has designated its PLacental eXpanded, or PLX, cells orphan drug status for the treatment of aplastic anemia. In August of 2011, the company received orphan drug status from the FDA for its PLX cells for the treatment of Buerger's disease.
PSTI closed Thursday's trading 3.30% higher at $3.44.
Repros Therapeutics Inc. (RPRX: Quote) soared over 24% to close Thursday's trading at $12.69 after the FDA recommended the company's first of the two pivotal studies - ZA-301, of Androxal to be completed as originally planned. Androxal is being evaluated in the treatment of secondary hypogonadism.
The company's plan regarding the second pivotal study - ZA-302, to enroll additional patients has also been accepted by the FDA.
Top-line results from ZA-301 are expected in Q3 2013.
Valeant Pharmaceuticals International Inc. (VRX: Quote) on Thursday announced it has acquired U.S. rights for Targretin capsules and Targretin gel 1% from Eisai for $65 million upfront, plus potential contingent payments based on certain milestones. Eisai will retain its rights to Targretin outside of the United States.
Targretin is approved to treat skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL when at least one systemic therapy has not worked.
VRX closed Thursday's trading at $65.69, down 0.83%.
It was quite disappointing for VIVUS Inc. (VVUS: Quote) on Thursday when the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, confirmed its decision of not to recommend approval of obesity drug Qsiva in the European Union.
Last October, the CHMP recommended against approval of Qsiva for the treatment of obesity in the European Union due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use.
VIVUS requested a re-examination of the opinion, following which the CHMP again reviewed the Marketing Authorization Application for Qsiva.
However, this time too, the CHMP has indicated that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety.
Qsiva was approved by the FDA in July 2012 and is sold under the trade name Qsymia.
VVUS closed Thursday's trading at $12.88, down 1.90%.
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