Industry News

- Read more about Hikma receives FDA approval for Neostigmine Methylsulfate Injection
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.

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- Read more about Teva and Active Biotech Announce Discontinuation of Higher Doses of Laquinimod in Two Multiple Sclerosis Trials
Teva Pharmaceutical Industries Ltd. and Active Biotech announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients.
- Read more about Elanco finalises Novartis Animal Health India acquisition
Animal health products and knowledge services firm Elanco on Tuesday announced it had finalised its acquisition Novartis Animal Health India.
- Read more about Addex’ Dipraglurant get Orphan Drug Designation from the FDA
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.
- Read more about FDA approved Investigational New Drug for NBTXR3 in a new clinical study in prostate cancer
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.
- Read more about Merck KGaA, Darmstadt, Germany, Pfizer and Syndax collaborate to investigate avelumab and entinostat
Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals, Inc. announced that they have entered into a collaboration agreement to evaluate avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory T-cells), in patients with heavily pre-treated, recurrent ovarian cancer. Avelumab is currently under clinical investigation across a broad range of tumor types by the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer. This is an exclusive agreement between the alliance and Syndax to study the combination of these two investigational agents in ovarian cancer. Syndax will be responsible for conducting the Phase Ib/II clinical trial in ovarian cancer.
- Read more about NeuroDerm announce start of phase II study of ND0612H in advanced Parkinson’s disease
NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for CNS disorders, announced the start of patient enrollment in a first efficacy trial of ND0612H, the company’s continuously administered subcutaneous levodopa/carbidopa solution. This treatment is intended to be an alternative to current treatments for patients with advanced Parkinson’s disease that require surgical intervention.
- Read more about Global Blood Therapeutics Receives FDA Orphan Drug Designation for GBT440 in Sickle Cell Disease
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.
- Read more about US FDA accepts Minerva Neurosciences' IND for MIN-101 to treat schizophrenia
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.
- Read more about USFDA Grants Orphan Drug Designation to Pluristem’s PLX-PAD Cells for Treatment of Severe Preeclampsia
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.