News Headlines

  1. Amgen Presents Results Highlighting The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In The Longest Duration Study Of A PCSK9 Inhibitor To Date At AHA Scientific Sessions 2018

    Amgen (NASDAQ: AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with Repatha® (evolocumab) was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse events over time and no neutralizing antibodies

  2. Aptinyx Exploratory Clinical Studies Provide First Evidence That NYX-2925 Elicits Rapid, Persistent, NMDAr-Mediated Pharmacodynamic Activity In Humans

    Aptinyx Inc. (NASDAQ: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that exploratory clinical studies of its novel NMDA receptor (NMDAr) modulator, NYX-2925, provide the first evidence that oral dosing of the product candidate induces pharmacodynamic activities in humans that are understood to be NMDAr-mediated.

  3. Nkarta Therapeutics Reports Potent Natural Killer Cell Anti-Cancer Activity In Preclinical Tumor Model

    Nkarta Therapeutics, a privately-held cell therapy company developing Natural Killer (NK) cell therapies to fight cancer, today announced preclinical data highlighting the anti-cancer activity of engineered NK cells in a presentation at the Society of Immunotherapy for Cancer meeting being held in Washington D.C.

  4. OncoMed Announces Early Clinical Data For Anti-TIGIT Antibody

    OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, today announced initial results from the Phase 1a dose escalation portion of a Phase 1a/b trial of etigilimab, the company’s anti-TIGIT antibody.

  5. InflaRx Completes Enrollment In Phase IIb Clinical Trial With Lead Candidate IFX-1 In Hidradenitis Suppurativa

    InflaRx N.V. (Nasdaq:IFRX), a biopharmaceutical company developing innovative therapeutics to treat devastating inflammatory diseases by targeting the complement system, a key component of the innate immune system, today announced that patient enrollment has been completed in the phase IIb study to determine the safety and efficacy of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients suffering from moderate or severe Hidradenitis Suppurativa (HS).

  6. Vivozon’s Non-Opioid Pain Killer Has Been Granted The FDA’s Fast Track Designation Through Regulatory Strategy Support From MMS

    MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced that the company has successfully assisted Korea-based Vivozon Inc. in achieving a Fast Track Designation from the Food and Drug Administration (FDA) for VVZ-149, a non-opioid pain killer.

  7. CRF Health, A CRF Bracket Company, Sees First-In-Class eCOA Solutions Secure 15 Global Dermatology Trials

    RF Health, a CRF Bracket company, the leading provider of patient-centered eSource technology solutions for the life sciences industry, today announced the awarding of two new contracts by top-20 pharma companies, which will see the company’s innovative eCOA solutions used to capture patient reported outcomes in 15 global dermatology trials.

  8. Apple’s Face ID Security Available In Mobile App For Clinical Trial Management

    Crucial Data Solutions announces the latest update to their native mobile app for clinical trial data collection and management. TrialKit™, an eClinical platform, has incorporated Apple’s biometric technologies for user authentication. Now, iPhone users with compatible generation devices can quickly and easily sign in to the app via facial recognition or fingerprint recognition.

  9. Sharp Clinical Announces Partnership With Berkshire Sterile Manufacturing

    Sharp, a global leader in contract packaging and clinical supply services, part of UDG Healthcare, confirmed a preferred partner agreement with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM). As part of the agreement, Sharp will offer sterile fill/finish to augment its existing clinical manufacturing service to the pharmaceutical, biotech and clinical research sectors.

  10. Abeona Therapeutics And REGENXBIO Announce Worldwide Exclusive Licenses For The Treatment Of Four Rare Lysosomal Storage Disorders Using NAV AAV9 Vector

    Abeona Therapeutics Inc, a leading clinical-stage biopharmaceutical company focused on developing novel gene and cell therapies for life-threatening rare diseases, and REGENXBIO (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced a license agreement to REGENXBIO’s NAV AAV9 vector for the treatment of four diseases: Sanfilippo syndrome type A (MPS IIIA), Sanfilippo syndrome type B (MPS IIIB), Infantile Batten Disease, also known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease), and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis type 3 (CLN3 Disease).