FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder
29 June 2017
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ganaxolone for the treatment of CDKL5 Disorder. Ganaxolone is currently being evaluated in children with CDKL5 Disorder in a Phase 2 clinical trial.
27 June 2017
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced that it has initiated its Phase 2 double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and pharmacokinetics (PK) of ganaxolone IV in women diagnosed with severe postpartum depression (Magnolia study).
08 June 2017
Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced that, today Charles C. Wykoff , MD, PhD, presented preliminary results from a non-interventional and retrospective trial (the “Extension Study”) of patients who had participated in the completed Phase 2 trial of CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”). 74% of RVO Patients Receiving CLS-TA for Suprachoroidal Administration Together with Intravitreally Administered EYLEA® Did Not Receive Any Additional Treatment Over 9 Months.
02 June 2017
NovaDigm Therapeutics, a company developing innovative immunotherapeutics and preventative vaccines for fungal and bacterial infections, today announced awards totaling $6 million from the U.S. Department of Defense to conduct a clinical study of NDV-3A in military personnel at high risk for skin and soft tissue infections due to Staphylococcus aureus (“S. aureus”), including methicillin-resistant S. aureus (MRSA). NovaDigm will collaborate with the Uniformed Services University of the Health Sciences (USU) on the execution of the Phase 2a study among U.S. Army Infantry trainees at Fort Benning, GA.
Syndax Prices Public Offering of Common Stock
24 May 2017
Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX) announced today the pricing of an underwritten public offering of 3,750,000 shares of its common stock at a price to the public of $13.25 per share. The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $49.7 million. The offering is expected to close on May 31, 2017, subject to customary closing conditions.
Syndax Announces Proposed Public Offering of Common Stock
23 May 2017
Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX) announced today that it plans to offer and sell, subject to market and other conditions, $50 million of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Syndax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering. All of the shares in the proposed offering are to be sold by Syndax.
17 May 2017
Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today announced results from the melanoma cohort of the ongoing Phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy, which will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2-6, 2017 in Chicago, Illinois.
17 May 2017
Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare pulmonary diseases, announced today the full enrollment of its phase 2b clinical trial testing its flagship anti-inflammatory drug candidate, once-daily oral acebilustat, in adult CF patients (NCT02443688). The study is investigating the potential of acebilustat to reduce lung inflammation and preserve lung function over the course of 48 weeks in CF patients at a high risk for rapid lung function decline.
16 May 2017
Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today reported that the ENCORE 601 non-small cell lung cancer (NSCLC) cohort enrolling patients with disease progression on or after PD-1 therapy (programmed death receptor-1 (PD-1) and/or programmed death ligand 1, (PD-L1)) has met the pre-specified objective response threshold to advance into the second stage of the Phase 2 trial, and will re-open enrollment immediately.
Forever Young: 10 Anti-Aging Startups To Watch
16 May 2017
By 2050, the US population aged 65 and older is projected to reach 83.7M, almost double its population in 2012. To combat the aging process and help people lead longer and healthier lives, pharmaceutical corporates and tech giants alike have begun investing in startups that are specifically aiming to tackle the root causes of aging or age-related diseases. One of them - ReVision Optics.
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