Industry News

Elbrit Life Sciences dreaming Big on Indian Pharmaceutical Business

‘Elbrit Life Sciences’, a new pharmaceutical company based in Mumbai, India, today opened gates for business in India. The company would be serving the South Indian states initially and aims to cover the entire country with time. According to the sources, the company would be targeting cardiac and diabetes product segments in the present year. Elbrit Life Sciences is a part of a global business group based in UK with investments in science, research and education. The group has significantly invested in next generation healthcare such as genetic therapy, molecular biology, DNA mapping and biomarkers. The group also owns world renowned scientific and academic publishing brands.

Pfizer's two drugs significantly prolonged progression of tumor with Advanced Breast Cancer

Combination of Palbociclib with Letrozole significantly prolonging progression of tumor compared with single letrozole in post-menopausal women with estrogen receptor positive. This details resulted from PALOMA-1 study which is a Phase 2 trial designed to assess progression-free survival in post-menopausal women with ER+, HER2- advanced breast cancer receiving palbociclib in combination with letrozole versus letrozole alone.

U.S. FDA approval for Eliquis® (apixaban) to reduce risk of thrmobosis in Hip or Knee Replacement Surgery

Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

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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