CEL-SCI Corp. (CVM) is all set to expand its phase III trial of investigational therapy Multikine, developed as a potential first-line treatment for advanced primary head and neck cancer, into Romania.
In accordance with the clinical protocol, the company plans to conduct the study in approximately 20 countries in addition to the U.S., and Romania is the 18th country to join the Head and Neck cancer trial.
The company is aiming to complete enrol lment of subjects to the phase III head and neck cancer study by the end of 2015.
CVM closed Monday's trading at $0.67, up 3.86%. In after-hours, the stock was up 25.37% at $0.84.
Impax Laboratories Inc. (IPXL) has received FDA approval for generic Lamictal Orally Disintegrating Tablets, of strengths 25mg, 50mg, 100mg and 200mg in blister packaging.
Lamictal ODT (Orally Disintegrating Tablets) is an antiepileptic drug indicated for the treatment of epilepsy and bipolar disorder. The company acquired the approved Abbreviated New Drug Application for generic Lamictal ODT from Actavis plc (ACT) in July 2014.
Impax expects to be entitled to 180 days of market exclusivity for its generic Lamictal ODT.
IPXL touched a new high of $38.91 on Monday before closing the day's trading at $38.83.
Insys Therapeutics Inc.'s (INSY) Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer has been granted orphan drug designation by the FDA.
Insys acquired Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) formulation during its merger in 2010 with NeoPharm.
INSY closed Monday's trading at $49.71, down 0.02%.
Natus Medical Inc. (BABY) has acquired Global Neuro-Diagnostics, thereby entering the neurodiagnostic services market.
Global Neuro-Diagnostics, which was profitable in 2014, generated revenue of approximately $7 million.
BABY closed Monday's trading at $37.03, up 2.63%.
NovaBay Pharmaceuticals Inc. (NBY) has signed a nationwide distribution agreement with Cardinal Health (CAH) for its prescription lid and lash hygiene product Avenova.
Combined with NovaBay's previous distribution agreements with McKesson Corp. (MCK) and Vision Source, Avenova will now be available to more than 90 per cent of the nation's 67,000 retail pharmacies and to thousands of optometrists' offices across the country.
Avenova is intended for the management of debilitating eye conditions such as blepharitis, Meibomian gland dysfunction and associated dry eye.
NBY closed Monday's trading 2.17% higher at $0.61.
Pfizer Inc. (PFE) has announced a 20 cent reduction of its per-dose price for its pneumonia vaccine Prevenar 13, from $3.30 per-dose to $3.10 per dose for the new four-dose vial presentation in order to ensure the world's most resource-limited countries have access to the vaccine.
The price cut is expected to be introduced under the Advanced Market Commitment program in 2016, and will be extended to all Gavi eligible and Gavi graduated countries through 2025.
Gavi is an international organisation that was created in 2000 to improve access to new and underused vaccines for children living in the world's poorest countries.
Rockwell Medical Inc. (RMTI) has received FDA approval for its drug candidate Triferic, intended for iron replacement and maintenance of hemoglobin in hemodialysis patients.
Triferic is the first product that can safely allow dialysis patients to maintain target hemoglobin without the need for IV iron, noted the company.
RMTI closed Monday's trading at $10.73, down 0.74%.
Synageva BioPharma Corp. (GEVA) has commenced dosing in a phase 1/2 study with SBC-103 in patients with mucopolysaccharidosis IIIB (MPS IIIB, also known as Sanfilippo B syndrome).
The trial will enroll approximately nine patients, two years of age or greater but less than 12 years of age, with definitive diagnosis of MPS IIIB and developmental delay. The company plans to report preliminary data from this study during the second half of this year.
GEVA hit a new high of $122.88 on Monday before closing the day's trading at $120.92.
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