AveXis, Inc., a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for AVXS-101, the company’s lead development candidate for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients.
The European Medicines Agency (EMA) has accepted for review, Mylan’s Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Eisai Inc. and Arena Pharmaceuticals, Inc. announced that the Federal Commission for the Protection Against Sanitary Risk has granted regulatory approval of the chronic weight management agent VENESPRI® for commercialization by Eisai Laboratorios in Mexico.
The U.S. Food and Drug Administration has approved an expanded indication for Synjardy® (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). SYNJARDY, from Boehringer Ingelheim and Eli Lilly and Company, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate.
Cerulean Pharma, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Cerulean's lead nanoparticle-drug conjugate, CRLX101, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer.
Allergan plc and Adamas Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC® (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
Ajanta Pharma Limited received final approval from US FDA and launched Omeprazole and Sodium Bicarbonate Capsules in the US market, through its wholly owned subsidiary Ajanta Pharma USA Inc.
U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for a 500mg chewable tablet formulation of mebendazole from Janssen Pharmaceuticals.
For HIV-infected mothers whose immune system is in good health, taking a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission by breast milk to their infants, according to results from a large clinical trial conducted in sub-Saharan Africa and India
Biologists and mathematicians from MIPT, Stony Brook University and other scientific research centres have taught a computer to predict the structure of protein complexes in a cell 10 times faster than before. The study has been published in Proceedings of the National Academy of Sciences of the USA.