Pharma News

Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

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In recent years, the search for new cancer treatments has increasingly focused on immunotherapies that harness the body's own defenses to fight tumors. Adoptive cell therapy (ACT) is a powerful immunotherapeutic strategy that can effectively control some cancers but that also has drawbacks. To administer ACT, T cells are withdrawn from a patient and cultivated in a laboratory (ex vivo) for weeks or months, until a massive number of cells are available to be injected back into the patient. During ex vivo cultivation, the T cells often lose potency and life span.

A joint study conducted by scientists at the National Academy of Sciences in Belarus and Kazan Federal University in Russia, looks at the role of nitric oxide (NO) in brain tissue in simulated ischemia in rats.

Celgene Corporation recently announced results from two phase 3 trials evaluating the efficacy and safety of the drug ozanimod. Ozanimod was invented by scientists at The Scripps Research Institute (TSRI). Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, and was compared to the first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The findings from the two pivotal phase 3 (SUNBEAM and RADIANCE Part B) trials pave the way for ozanimod to enter the New Drug Approval process with the U.S. Food and Drug Administration (FDA).

The vaccine that protects against cancer-causing types of human papillomavirus (HPV) also prevents an uncommon but incurable childhood respiratory disease, according to a new study published in The Journal of Infectious Diseases. The findings suggest that the chronic and difficult-to-treat condition, recurrent respiratory papillomatosis, is disappearing in Australian children as a result of the nation’s highly successful HPV vaccination program.

Alembic Pharmaceuticals Ltd  announced that through its 100% owned subsidiary, Alembic Pharmaceuticals Inc., it has completed acquisition of West Caldwell, New Jersey, U.S.A. based generic drug developer Orit Laboratories LLC (“Orit”) along with real estate, owned by Okner Realty LLC (“Okner”).

Dr. Reddy’s Laboratories Ltd. is pleased to announce that generic Azacitidine for injection 100 mg/vial, a bioequivalent generic version of VIDAZA® (azacitidine for injection), is approved by Health Canada

Boehringer Ingelheim announced one-year data from VOLTAIRE®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira®*. The 48-week data showed that Cyltezo® is equivalent, with no clinically meaningful differences in efficacy, safety and immunogenicity to Humira® in people with moderately-to-severely active rheumatoid arthritis (RA), including in patients who switched from Humira® to Cyltezo® at week 24.

Takeda Pharmaceutical Company Limitedannounced that data from an 18-month interim analysis of the ongoing Phase 2 DEN-204 trial of its live, attenuated tetravalent dengue vaccine candidate, TAK-003 (also referred to as TDV), have been published in The Lancet Infectious Diseases. The results of this interim analysis, a pre-planned evaluation of data from an ongoing trial, show that TAK-003 is associated with a reduction in the incidence of dengue in children and adolescents. These data were also presented at the American Society of Tropical Medicine and Hygiene Annual Meeting. Phase 3 data are required to confirm these findings.

Cipla Ltd, a global pharmaceutical company which uses cutting-edge technology and innovation to meet the everyday needs of all patients, announced that its subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), has received final approval for its Abbreviated New Drug Application (ANDA) for Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Genzyme’s Renvela® Tablets, 800 mg.