Industry News

Ranbaxy saw some good news from the US drug regulator just days before the announcement of its acquisition by Sun Pharmaceutical in a $4-billion deal inclusive of debt.

‘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.

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.

Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd announced on April 4, 2014 that they have entered into definitive agreements pursuant to which Sun Pharma will acquire 100% of Ranbaxy in an all-stock transaction.

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.

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 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.

Karkhadi (Gujarat) based plant of Sun Pharmaceuticals imposed ban by USFDA. This ban is applied on import of all drug products from this plant. This detention was carried out without physical examination of drugs because company failed to met good manufacturing practices rules, as per FDA website on Wednesday.

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.

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