February 2016

For the third quarter ended 31st December 2015, Zydus Cadila reported Total Operating Income of Rs. 2428 crores, up by 10% from Rs. 2205 crores in the corresponding quarter of the previous year on a consolidated basis. Net Profit for the same period was up by 38% from Rs. 282 crores to Rs. 390 crores.

Dr. Reddy’s announced that its US subsidiary, Promius PharmaTM, has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA).

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental.

Vertex Pharmaceuticals announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the use of KALYDECO® (ivacaftor) in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward.

Vizient, Inc.  has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing  on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech).

Australian scientists have developed a revolutionary "bionic spine" which they believe will enable paralysed patients to walk again, the media reported.

Researchers in the US have discovered a new bacterial species that causes the infectious Lyme disease in people.

An implantable device can deliver a particularly toxic cocktail of drugs directly to the highly lethal pancreatic tumours to stunt their growth or in some cases, shrink them all while showing signs that the rest of the body would be spared of the toxic side effects, new research has found.

Researchers have found that a protein, the levels of which can be easily monitored in routine blood tests, could serve as a new biomarker for Alzheimer's disease that slowly destroys memory and thinking skills.