Government of India is considering to replace some animal tests with alternative methods in rabbits, guinea pigs or mice with respect to the approval of new drugs and therefore they are looking for replacements in Indian situation.
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Department of Pharmaceuticals, ministry of health & Family welfare have made important advances in last two years. Which are as follows:
Therabron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to rhCC10 (recombinant human Club Cell 10 kDa Protein), the company’s lead product candidate,for the prevention of bronchopulmonary dysplasia and chronic respiratory morbidity (CRM) in preterm infants. The Rare Pediatric Disease Designation supplements the Fast Track Designation recently granted by the FDA for rhCC10. This program has also previously been granted Orphan Status by both the US and EU Health Authorities.
As part of Johnson & Johnson’s commitment to combat Ebola, Janssen Pharmaceutica NV announced that the Idylla™ Ebola Virus Triage Test (Idylla™ EBOV Test) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The Idylla™ Ebola Virus Triage Test is a diagnostic that detects the presence of the Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease and was jointly developed by Janssen Diagnostics, a division of Janssen Pharmaceutica, Biocartis NV (Biocartis), and the Belgium Institute of Tropical Medicine.
Pixium Vision, a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK to initiate a clinical trial for patients who have lost sight due to retinitis pigmentosa (RP) with the IRIS II bionic vision system. This system being evaluated includes a mini bio-inspired camera and a 150 electrode epi-retinal implant with an explantable design.
Vertex Pharmaceuticals Incorporated, a global biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Orkambi (lumacaftor/ivacaftor) in people with cystic fibrosis (CF) ages 6 to 11 who have two copies of the F508del mutation. The FDA granted Vertex's request for Priority Review of this sNDA, and a target review date of September 30, 2016 was set under the Prescription Drug User Fee Act (PDUFA).
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