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Oxford Biomedica Broadens its Viral Vector Capabilities With the Launch of Oxford Biomedica Solutions March 11, 2022
Oxford Biomedica plc recently announced it has completed its deal with Homology Medicines Inc. to establish Oxford Biomedica Solutions LLC,...Denali Therapeutics Announces Initiation of Phase 1/2 Clinical Trial March 9, 2022
Denali Therapeutics Inc. recently announced dosing has begun in a Phase 1/2 clinical trial of DNL593 (PTV:PGRN) for the potential...Durable & Deepening Clinical Responses Observed in Post-Treatment Period of Evelo Bioscience’s Phase 2 Clinical Trial February 28, 2022
Evelo Biosciences, Inc. recently announced data from the post-treatment follow-up (Part B) of its Phase 2 trial of EDP1815 in...Gracell Doses First Patients in First-in-Human Clinical Trial of Dual-Targeting CAR-T Therapy February 17, 2022
Gracell Biotechnologies Inc. recently announced it has dosed multiple patients in a clinical trial evaluating GC012F, the company's autologous CAR-T...Spero Therapeutics Announces Positive Topline Results From Phase 1 Bronchoalveolar Lavage Clinical Trial February 16, 2022
Spero Therapeutics, Inc. recently announced topline findings from its Phase 1 bronchoalveolar lavage (BAL) clinical trial of SPR206, an intravenously...Neurocentria Obtains FDA Approval to Conduct Pivotal Phase 2b/3 Clinical Trial for Testing Safety & Efficacy of Drug Candidate NRCT-101SR in Adults With ADHD February 15, 2022
Neurocentria Inc. has recently received FDA approval to conduct a pivotal Phase 2b/3 human clinical trial to test the efficacy...Cerevel Therapeutics Announces Positive Topline Results for Darigabat in Phase 1 Clinical Trial in Acute Anxiety February 15, 2022
Cerevel Therapeutics recently announced positive results from its Phase 1 healthy volunteer clinical trial to evaluate darigabat, a novel alpha-2/3/5 selective GABAA receptor positive allosteric modulator….
Denali Therapeutics Announces Continued Progress in DNL310 Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2/3 Clinical Trial February 10, 2022
DNL310 is an investigational brain-penetrant enzyme replacement therapy intended to treat both central nervous system (CNS) and peripheral manifestations of MPS II (Hunter syndrome). ….
Ocuphire Completes Enrollment in MIRA-3 Pivotal Phase 3 Clinical Trial February 8, 2022
Ocuphire Pharma, Inc. recently announced it has completed enrollment in MIRA-3, the second Phase 3 FDA registration trial evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically….
uniQure Announces Dosing of First Patients in European Open-Label Clinical Trial of AMT-130 Gene Therapy in Huntington’s Disease February 7, 2022
uniQure N.V. recently announced the dosing of the first two patients in its European open-label Phase 1b/2 clinical trial of...Hepion Pharmaceuticals’ Rencofilstat, in Combination With an Immune Checkpoint Inhibitor, Demonstrates Synergistic Anti-Tumor Activity in a Nonclinical Liver Cancer Study January 26, 2022
Hepion Pharmaceuticals, Inc. recently announced the results of a nonclinical research study showing that its clinical phase drug candidate, rencofilstat (CRV431), synergistically decreased liver tumor….
Catalent Launches New Xpress PharmaceuticsT Service to Expedite Development of Oral Drugs for Adaptive Phase 1 Clinical Trials January 18, 2022
Catalent recently announced the launch of its new Xpress Pharmaceutics service, designed to accelerate the development of oral drugs through Phase 1 clinical studies. By integrating formulation….
Clinical Trial Begins in the UK to Investigate 3-in-1 High Blood Pressure Pill January 17, 2022
George Medicines recently announced its proprietary triple low-dose combination pill, GMRx2, will be trialed in UK patients with high blood...Biomea Fusion Releases Preclinical Data With BMF-219 in Diabetes January 6, 2022
Biomea Fusion, Inc. recently announced BMF-219 displayed remarkable activity in both the Zucker Diabetic Fatty (ZDF) Rat and the Streptozotocin-Induced...Moderna Announces First Participant Dosed in Phase 1 Study of its Epstein-Bar Virus Vaccine January 5, 2022
Moderna, Inc. recently announced the first participant has been dosed in the Phase 1 study of mRNA-1189, the Company's Epstein-Barr Virus...Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine December 20, 2021
Novavax, Inc. recently announced the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine...Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron December 16, 2021
Vaxart, Inc. recently announced it plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron...SAB Biotherapeutics Announces SAB-176 Met its Primary Endpoint in Phase 2a Challenge Study in Adults Infected With Influenza Virus December 1, 2021
SAB Biotherapeutics recently announced that SAB-176, its investigational therapeutic for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and….
MARKET BRIEF - Navigating the Evolving Landscape of Rare Cancer Trials November 30, 2021
Rupa Doshi, PhD, and Sameena Sharif, PhD, explore the landscape of rare cancer clinical trials, from key considerations for study design and the value of biomarkers to the importance of the patient perspective and the options for speeding much-needed therapies to market.
Akoya Biosciences Secures CLIA Lab Certification, a Milestone for Applying its Spatial Biology Technologies to Accelerating Precision Cancer Therapies November 30, 2021
Akoya Biosciences, Inc., The Spatial Biology Company, recently announced its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, MA, has received its Certificate of Registration from the….