News Headlines

  1. Kura Oncology Announces FDA Clearance Of Investigational New Drug Application For Menin-MLL Inhibitor KO-539

    Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for KO-539, a potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) protein-protein interaction.

  2. Rexahn Announces Target Enrollment Reached In Phase 2a Clinical Trial Of RX-3117 In Combination With ABRAXANE® In First-Line Metastatic Pancreatic Cancer Patients

    Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical-stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, announced that is has completed enrollment in the Phase 2a clinical trial of RX-3117 in combination with ABRAXANE (paclitaxel protein-bound particles for injectable suspension) in first-line metastatic pancreatic cancer patients.

  3. Biogen Announces Agreement To Acquire Nightstar Therapeutics To Establish Clinical Pipeline Of Gene Therapy Candidates In Ophthalmology

    Biogen (Nasdaq: BIIB) today announced that it has entered into an agreement to acquire Nightstar Therapeutics (NST; Nasdaq: NITE), a clinical-stage gene therapy company based in London, United Kingdom, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. Under the terms of the proposed acquisition, Biogen will pay $25.50 in cash for each NST share.

  4. Lipomedix Announces Initiation Of Phase 1b Trial (LIPORAD-2018) Of Promitil® In Combination With Radiotherapy In Patients With Advanced Cancer

    Lipomedix, a clinical-stage, oncology-focused pharmaceutical company, involved in the development of innovative, safe and effective cancer therapy based on a pegylated liposomal drug delivery platform, today announced the initiation of a Phase 1b multicenter trial (LIPORAD-2018) to identify the optimal dose, safety and efficacy of its lead compound Promitil® in combination with external beam radiotherapy (EBR) in patients with advanced cancer requiring radiotherapy for inoperable primary tumors or metastatic disease.

  5. Premier Research Champions Patient Advocacy Community

    As part of its commitment to supporting the patient advocacy community and as a kickoff to Rare Disease Day on February 28 and March as Rare Disease Month, clinical research company Premier Research is announcing both a new scholarship for rare disease patient advocates in partnership with Professional Patient Advocates in Life Sciences (PPALS) and the launch of a new Patient and Stakeholder Engagement (PASE) capability led by Juliet Moritz.

  6. TG Therapeutics Announces Positive Outcome From UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib In Patients With Relapsed/Refractory Marginal Zone Lymphoma

    TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced that the Marginal Zone Lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating umbralisib (TGR-1202), our novel, once daily, PI3K delta inhibitor, met the primary endpoint of Overall Response Rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=69). The results met the Company’s target guidance of 40-50% ORR.

  7. InflaRx Receives Approval To Initiate Phase IIa Clinical Trial With Lead Candidate IFX-1 In Pyoderma Gangraenosum

    InflaRx N.V.(Nasdaq: IFRX), an innovative biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the approval of a Clinical Trial Application by Health Canada for a phase IIa clinical trial evaluating the Company’s lead product candidate, IFX-1, in Pyoderma Gangraenosum. This is the third autoimmune disease for which InflaRx is developing IFX-1.

  8. Minoryx Therapeutics Receives Approval From Spanish Regulatory Agency To Initiate Phase 2 Study In Friedreich’s Ataxia

    Minoryx Therapeutics, a company specializing in the development of new drugs for orphan diseases, recently announces that it has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) to launch a phase 2 clinical trial in Friedreich’s Ataxia with its lead candidate, MIN-102.

  9. Groundbreaking Transparency Application That Anonymizes Patient Data In Clinical Trials Launched By Trialassure

    TrialAssure- a leading, global software company focused on developing clinical trial transparency tools – announced recently the limited release of ANONYMIZE DS, an all-new software-as-a-service (SaaS) application that allows sponsors to anonymize clinical trial data automatically.

  10. CRF Bracket Grows More In First Quarter Together Than Either Company Achieved Alone In 2018

    CRF Bracket recently closed its first full quarter as a combined business after CRF Health and Bracket merged in September of 2018.