Industry News

GSK marketed products Mekinist in combination with Tafinlar received FDA nod for Advanced Melanoma

FDA approved combination therapy of Mekinist (trametinib) and Tafinlar (dabrafenib) for treatment of advanced melanoma that is unresectable or metastatic. In May 2013, FDA had already approved both drugs as single agents to treat patients with unresectable or metastatic melanoma, skin cancer.

Novartis's Jakavi ® shows positive Phase III results in Polycythemia Vera

Novartis announced that Jakavi ® (ruxolitinib) showed positive reponse in compare to present therpies for Polycythemia Vera, a rare and incurable blood cancer with increase number of erythrocytes production. In phase III trial, Jakavi ® succeed to maintain hematocrit control, erythrocytes volume, without the need of phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea.

FDA issued warning letter against Indian based Canton Laboratories upon quality issues

During  their last investigation in April 2013 at Canton Laboratories- Vadodara,  U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.

Synthetic Biologics announces issuance of US Patent for the use of Oral Estriol -Trimesta™ for treatment of Multiple Sclerosis & other Autoimmune Diseases

Synthetic Biologics, Inc., a developer of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA).

IMBRUVICA™ gets nod from USFDA for treatment of Chronic Lymphocytic Leukemia - rare blood and bone marrow disease

The U.S. Food and Drug Administration expanded the approved use of Imbruvica™ which contains ibrutinib, for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy on Wednesday, 12 Feb, 2014. Imbruvica™ is manufactured by Pharmacyclics based at Sunnyvale, California.

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