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- Read more about 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.
- Read more about 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.
- Read more about 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).
- Read more about 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.
- Read more about 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.
- Read more about Implantable device could help shrink pancreatic tumours
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.
- Read more about Blood test for Alzheimer's disease comes a step closer
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.
- Read more about 3D-printed liver tissue for drug screening created in lab
A team led by engineers at University of California-San Diego has 3D-printed a tissue that closely mimics the human liver's sophisticated structure and function.
- Read more about Dr.Reddy's Sernivo spray gets USFDA nod
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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- Read more about PhRMA hits on Indian Intellectual regime
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.