Sarepta Therapeutics, Inc., a developer of innovative RNA-targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
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.
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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).
Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.
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India will be continued in priority watch list in the year 2016 as per Special 301 report submitted by PhRMA (Pharmaceutical Research and Manufacturers of America) to USTR (United States Trade Representative). PhRMA clearly reproval Indian IPR (Intellectual Property Rights) regime.
Bristol-Myers Squibb’s announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.
Amarantus Bioscience Holdings Inc. a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF(mesencephalic-astrocyte-derived neurotrophic factor). MANF was previously granted orphan drug designation (ODD) by the US FDA in December 2014.
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