Clinical Trials
Medicago and GSK Announce the Approval by Health Canada of COVIFENZ®, an Adjuvanted Plant-Based COVID-19 Vaccine
A vaccine manufactured in plants and developed in Canada 24/02/2022 — QUEBEC CITY & LONDON — (BUSINESS WIRE) Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today […]
Personalis Announces Collaboration with UC San Diego Moores Cancer Center for Clinical Genomic Testing and Research into Composite Biomarkers and Minimal Residual Disease Detection
15/02/2022 — MENLO PARK, Calif. — (BUSINESS WIRE) Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced a strategic collaboration with the Moores Cancer Center […]
Humanigen and Cenexi Announce Collaboration to Manufacture Lenzilumab in France
Cenexi to Become Preferred Drug Product Supplier for France and the European Union 09/02/2022 — BURLINGAME, Calif. & FONTENAY-SOUS-BOIS, France — (BUSINESS WIRE) Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage […]
Agendia to Provide First Digital MammaPrint Capability to Brazil
AI solution will expand Agendia’s testing platform in the Brazilian breast cancer market Digital MammaPrint offers fast turnaround time to molecular diagnostics, delivering actionable information to physicians treating patients with […]
Agendia Appoints Suja Chandrasekaran and Scott Mendel to Board of Directors, Strengthening Advisory Group to Support Company Momentum
06/01/2022 — IRVINE, Calif. & AMSTERDAM — (BUSINESS WIRE) Agendia, Inc., a commercial stage company focused on precision oncology for breast cancer, today announced the appointment of healthcare industry veterans […]
Medicago submits Phase 3 data to Health Canada for its plant-based COVID-19 vaccine candidate
Final portion of data submitted as part of New Drug Submission for COVID rolling review COVID-19 vaccine candidate fully developed in Canada submitted for authorization 16/12/2021 — QUEBEC CITY — […]
Analysis Presented at SABCS 2021 Confirms MammaPrint® and BluePrint® Predict Outcomes Following Neoadjuvant Chemotherapy
Data signal importance of serial genomic testing in order to appropriately adjust breast cancer treatment plans 09/12/2021 — IRVINE, Calif. & AMSTERDAM — (BUSINESS WIRE) Agendia, Inc., a world leader […]
Agendia Presents Data at SABCS 2021 Showing MammaPrint® and BluePrint® More Robustly Identify Genomic Differences in HR+ HER2- Breast Cancers in Black and White Women Beyond Clinical Factors
ER+ tumors reclassified by BluePrint as Basal-type occur at a higher frequency in Black women compared to White women Understanding tumor biological differences via MammaPrint and BluePrint and will drive […]
Medicago and GSK Announce Positive Phase 3 Efficacy and Safety Results for Adjuvanted Plant-Based COVID-19 Vaccine Candidate
Primary endpoints and secondary endpoints for which data are available were met in trial dominated by COVID-19 variants Efficacy demonstrated against all variants seen in the study, including 75.3% efficacy […]
The Lancet Respiratory Medicine Publishes Peer-Reviewed Paper and Independent Expert Commentary on Positive Phase 3 Lenzilumab Results
Lenzilumab is a variant-agnostic therapeutic that targets the dysregulated host immune response, an approach which may be of greater value than targeting the virus in hospitalized patients1 Per the paper, […]
LintonPharm Announces First Patient Dosed in Phase 1 Clinical Trial of Catumaxomab for Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin
01/12/2021 — GUANGZHOU, China — (BUSINESS WIRE) LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, today […]
Personalis Announces Updates to NeXT Platform™ Incorporating Additional Key Profiling Capabilities for Advancing Oncology Biomarkers
02/11/2021 — MENLO PARK, Calif. — (BUSINESS WIRE) Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced the latest expansion of the Personalis NeXT Platform® adding […]
Dexlevo Introduces the World’s First Liquid-Type PCL at the AMWC, the World’s Largest Aesthetic and Anti-Aging Congress
This marks its entry into the European market 29/10/2021 — SEOUL, South Korea — (BUSINESS WIRE) Dexlevo, which signed an MOU with Hugel, attended the 19th Aesthetic & Anti-aging Medicine […]
European Commission Selects Humanigen’s Lenzilumab as One of the 10 Most Promising Treatments for COVID-19
Ten most promising treatments for COVID-19 identified by the European Commission’s independent experts as having “the highest potential impact on the pandemic”* European Commission’s independent panel of 10 experts across […]
Kyowa Kirin International: New Real World Evidence Underlines Benefits of POTELIGEO®▼ (mogamulizumab) Treatment for Cutaneous T-cell Lymphoma (CTCL) Patients
Patients responded better to treatment with POTELIGEO in real life, compared to data from the pivotal Phase 3 MAVORIC trial1 14/10/2021 — GALASHIELS, Scotland — (BUSINESS WIRE) Kyowa Kirin International […]
Seagen Announces Last Patient Enrolled in Phase 2 MOUNTAINEER Trial Evaluating TUKYSA® (Tucatinib) Regimen in HER2-Positive Metastatic Colorectal Cancer
– Trial Designed to Support an Accelerated Approval Application in the U.S. – 28/09/2021 — BOTHELL, Wash. — (BUSINESS WIRE) Seagen Inc. (Nasdaq: SGEN) today announced it completed patient enrollment […]
CEM Corporation & AmbioPharm Form U.S. Partnership for GMP Peptide Production
14/09/2021 — MATTHEWS, N.C. & NORTH AUGUSTA, S.C. — (BUSINESS WIRE) CEM Corporation and AmbioPharm, Inc. are excited to announce the formation of a partnership for production of GMP peptides […]
Quotient Sciences Announces Multimillion-Pound Investment in Drug Substance Manufacturing Facility
25/08/2021 — NOTTINGHAM, U.K. — (BUSINESS WIRE) Quotient Sciences, the drug development and manufacturing accelerator, announced a £6.3 million-pound investment in its recently acquired manufacturing facility in Alnwick, U.K. The […]
Merz and Israeli Start-Up Vensica Launch Partnership for Needleless Treatment of Overactive Bladder
11/08/2021 — FRANKFURT, Germany — (BUSINESS WIRE) wMerz Therapeutics, a business of the Merz Group and a leader in the field of neurotoxins, and the Israeli start-up Vensica Therapeutics Ltd., […]
Adagio Therapeutics Appoints Leading Pharmaceutical and Regulatory Executives to its Board of Directors
29/07/2021 — WALTHAM, Mass, — (BUSINESS WIRE) Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, […]
Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted COVID-19 Vaccine Candidate
Similar antibody response in adults and in the elderly after two doses Neutralizing antibody responses were 10 times higher than people recovering from COVID-19 No related severe adverse events reported […]
Aptorum Group Enters into an Agreement with Exeltis to Develop Aptorum’s Novel Preclinical Candidate Targeting Woman’s Gynecological Conditions
06/05/2021 — NEW YORK & LONDON & PARIS — (BUSINESS WIRE) Regulatory News: Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, has […]
Adagio Therapeutics Announces ADG20 Phase 1 Data and Initiation of Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19
Preliminary Data from Ongoing Phase 1 Trial in Healthy Volunteers Support ADG20 Safety and Pharmacokinetic Profile and SARS-CoV-2 Neutralizing Activity Phase 2/3 EVADE Trial to Evaluate ADG20 for the Prevention […]
Adagio Therapeutics Announces $336 Million Series C Financing to Support Rapid Advancement of Novel ADG20 #Antibody for the Treatment and Prevention of #COVID-19
Additional Capital to Fund Ongoing STAMP Pivotal Trial of ADG20 Designed to Support Emergency Use Authorization Submission Financing Follows First Quarter Appointment of Industry and Banking Veteran Jane Henderson as […]
LintonPharm Announces Authorization from China Health Authority (NMPA) to Proceed with a Phase 1/2 Trial Evaluating Catumaxomab for the treatment of Non-Muscle Invasive Bladder Cancer
13/04/2021 — GUANGZHOU, China — (BUSINESS WIRE) LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, today […]
Adagio Therapeutics Initiates Global Clinical Trial of ADG20 as a Treatment for COVID-19
Phase 1/2/3 STAMP Trial to be Conducted Globally, Including in Countries with High Rates of SARS-CoV-2 Variants Resistant to Other Monoclonal Antibody Products Potential for Early Access to Therapy by […]
Medicago and GSK Start Phase 3 Trial of Adjuvanted COVID-19 Vaccine Candidate
Trial to enroll up to 30,000 volunteers worldwide Fast Track designation granted by US FDA Feasibility study initiated of a vaccine candidate to address emerging variants 16/03/2021 — QUEBEC CITY […]
XPRIZE and Cognizant Announce Grand Prize Winners in Pandemic Response Challenge to Restart Economies Around the World
Winning AI models from VALENCIA IA4COVID19 of Spain and JSI vs COVID of Slovenia will help support decision-makers in determining pandemic intervention policies to safely reopen society 09/03/2021 — LOS […]
European Commission Approves Seagen’s TUKYSA® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
– Approved for Adult Patients with HER2-Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Anti-HER2 Treatment Regimens – – First HER-2 Tyrosine Kinase Inhibitor Combination Regimen to […]
Xeris Pharmaceuticals Receives European Commission Approval of Ogluo™ (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus
OGLUO™ Europe’s first and only ready-to-use liquid glucagon for rescue First availability expected in the fourth quarter Approval supported by data from pivotal Phase 3 study 12/02/2021 — CHICAGO & […]