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CTI BioPharma announces FDA Impose Partial Clinical Hold on Pacritinib IND

CTI BioPharma Corp. announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being conducted under the Company's Investigational New Drug ("IND") application for pacritinib. This clinical hold impacts part of the clinical work currently being conducted under the IND and will also affect planned clinical trials.


FDA cleared Sangamo BioSciences IND application For ZFN-Mediated genome editing treatment Of MPS I

Sangamo BioSciences, Inc., the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I (MPS I).


Sarepta Therapeutics receives notification of PDUFA extension for Eteplirsen

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.


Zydus Cadila’s net profit up by 38% in Q3

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.


Promius Pharma™ receives FDA approval for Sernivo (betamethasone dipropionate) Spray, 0.05%

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).


US FDA accepts for review Otsuka and Lundbeck's sNDA filing for labeling update of Rexulti® (brexpiprazole)

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 receives complete response letter from U.S. FDA for Use of KALYDECO® (ivacaftor)

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. endorses the FDA’s Biosimilars approval pathway

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 develop bionic spine for paralysed patients

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


New bacterial species that causes Lyme disease discovered

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