News Headlines

  1. TG Therapeutics Announces Completion Of Target Enrollment In The ULTIMATE Phase 3 Trials In Multiple Sclerosis

    TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that target enrollment in the ULTIMATE I and II Phase 3 trials has been achieved. ULTIMATE I and II are two independent Phase 3 clinical trials evaluating the safety and efficacy of ublituximab (TG-1101), the Company’s glycoengineered anti-CD20 monoclonal antibody, as compared to teriflunomide, in patients with relapsing forms of Multiple Sclerosis (RMS).

  2. Nicox Initiates Phase 2 Study Of NCX 470 In Open-Angle Glaucoma And Ocular Hypertension

    Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the initiation of a Phase 2 clinical study evaluating NCX 470, its novel, second-generation nitric oxide (NO)-donating prostaglandin analog, for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension by enrolling 10 patients today.

  3. Celtaxsys Announces Results Of Phase 2 Trial Showing Clinically Meaningful Improvement In Pulmonary Exacerbations In Cystic Fibrosis Patients

    Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced top line results of its Phase 2 EMPIRE-CF trial evaluating oral, once daily anti-inflammatory molecule, acebilustat, for the treatment of cystic fibrosis (CF), irrespective of the causative genotype.

  4. Aptinyx Initiates Phase 1 Study Of NYX-458

    Aptinyx Inc. (NASDAQ:APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced initiation of Phase 1 clinical development of NYX-458, its third novel product candidate that modulates N-methyl-D-aspartate (NMDA) receptors.

  5. Denali Therapeutics Announces Positive Clinical Results From LRRK2 Inhibitor Program For Parkinson’s Disease

    Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced positive results from its Phase 1 clinical study with DNL201, a small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2).

  6. Pharm-Olam International Supports Clinical Trials And Sponsors Compliance With GDPR

    Pharm-Olam International, a global, full-service contract research organization (CRO) specializing in oncology, infectious diseases and vaccines, rare and orphan diseases, provides multiple resources for life science organizations to comply with the new European Union General Data Protection Regulation (GDPR). Pharm-Olam provides education and consultation on how the GDPR affects clinical trial conduct and also works directly with companies to achieve compliance.

  7. GE Healthcare And Lantheus Announce Start Of A Phase 3 Clinical Trial Of Flurpiridaz, An Investigational Agent Being Evaluated For The Detection Of Coronary Artery Disease

    GE Healthcare and Lantheus Holdings, Inc., parent company of Lantheus Medical Imaging, Inc. (collectively “Lantheus”), have started a second Phase 3 clinical trial of Flurpiridaz 18F (called the AURORA study), an investigational agent being evaluated for the detection of coronary artery disease (CAD), the most common form of heart disease.

  8. Eisai And Merck Announce FDA Grants Breakthrough Therapy Designation For LENVIMA (Lenvatinib) In Combination With KEYTRUDA (Pembrolizumab) As Therapy For Previously Treated Patients With Advanced And/Or Metastatic Non-MSI-H/pMMR Endometrial Carcinoma

    Eisai Co., Ltd. and Merck, known as MSD outside the United States and Canada, announced recently that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for LENVIMA (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma (EC) who have progressed following at least one prior systemic therapy.

  9. Sanofi Ships First Flu Vaccines For 2018-2019 Season

    Sanofi Pasteur, the vaccine division of Sanofi (EURONEXT: SAN) (NYSE: SNY), today shipped the first of its nearly 70 million flu vaccine doses to health care providers for the upcoming flu season.

  10. Athenex Announces That Two Phase 3 Pivotal Efficacy Studies Of KX2-391 In Actinic Keratosis Achieved Their Primary Endpoints

    Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that both Phase 3 studies, KX-AK-003 and KX-AK-004, had achieved their primary endpoint of 100% clearance of actinic keratosis (AK) lesions at Day 57 within the face or scalp treatment areas, with each study achieving statistical significance (p<0.0001).