USFDA

Hikma Pharmaceuticals PLC (“Hikma”) ,  the fast growing multinational pharmaceutical group, announces that its Abbreviated New Drug Application (“ANDA”) for Neostigmine Methylsulfate Injection USP, 5 mg/10 mL and 10 mg/10 mL, multiple-dose vials has been approved by the U.S. Food and Drug Administration (“FDA”)  and that it has launched this product in the US market.

[adsense:336x280:8701650588]

Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). Orphan drug status provides Addex with a number of benefits including reduced development costs and seven years US market exclusivity from launch. Dipraglurant is a novel small molecule inhibitor of the metabotropic glutamate receptor 5 (mGluR5) that has successfully completed Phase II proof-of-concept testing in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID), an indication that has no approved treatment options. Addex is currently conducting an mGlu5 receptor occupancy clinical trial and is preparing to start a Phase III pivotal trial in PD-LID.

NANOBIOTIX, a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces the US Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application on the 30th of December. This allows Nanobiotix to launch its first clinical study in the US for its lead product NBTXR3 in prostate cancer, a new and very significant indication.

Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for GBT440 for the treatment of patients with sickle cell disease (SCD). GBT440 is being developed as a potentially disease-modifying therapy for SCD.

Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat CNS disorders, announced that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia.

Pluristem Therapeutics Inc.,  a leading developer of placenta-based cell therapy products, announced that the U.S. Food and Drug Administration has granted the Company’s PLX-PAD cells Orphan Drug Designation in the treatment of severe preeclampsia. Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in approximately 1% of pregnancies in Western countries.

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.

REGENXBIO Inc.  a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy,  announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-111, the Company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis Type I (MPS I).

Amarantus Bioscience Holding 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) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.

Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement.