News and Press Releases
European Commission approves RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure of prior therapy
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, have until now faced a poor prognosis and limited treatment options after disease progression on...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 27, 2024
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European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
First pan FGFR kinase inhibitor to be approved in the European Economic Area, for adults with unresectable or metastatic urothelial carcinoma and susceptible FGFR3 alterations Approval based on THOR results,...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 23, 2024
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Cumulus Oncology and leadXpro Achieve Critical Milestone in GPR68 Drug Discovery Project
Small Molecules Identified for Therapeutic Intervention in Oncology and Inflammation Edinburgh, Scotland, and Villigen, Switzerland, 20 August 2024 – Cumulus Oncology, Europe’s first oncology-focused biotech creation company, announces that, in...
Category: Drug Discovery
Posted: August 22, 2024
SGS Introduces New Specialized Bioanalytical Testing Services in North America
21 August 2024 -- Geneva, Switzerland -- SGS, the world’s leading testing, inspection and certification company, announces the introduction of new specialized bioanalytical testing services in the North American pharmaceutical...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: August 21, 2024
New Medable Studio Empowers Sponsors to Launch eCOA Solutions into Clinical Trials with Unparalleled Control and Efficiency
Medable Studio for eCOA now available; two top-10 pharma company early adopters 14 August 2024 -- California, US -- Medable Inc, the leading technology platform for clinical trials, today announced...
Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: August 14, 2024
COREX Logistics Appoints New CEO to Expand Global Growth
Clinical trial and pharmaceutical logistics specialists COREX Logistics have announced the appointment of Steve Healy as its new CEO of the organisation. Healy, COREX Logistics’ former Vice President of Business...
Category: Clinical Trials, Logistics, Other
Posted: July 30, 2024
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CHMP recommends RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options after disease progression on osimertinib1,2,3,4 ...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
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Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
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Deuterium Depletion Is the Key to Getting a Breakthrough in Cancer Therapy
Two review papers consolidate 30 years of research BUDAPEST, Hungary, July 25, 2024 / Biotech Newswire / -- HYD LLC for Cancer Research and Drug Development (HYD or the Company)...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: July 25, 2024
Eisai Selects Medidata’s Clinical Data Studio to Enhance and Modernize Clinical Trial Efficiency and Patient Experience
AI-enhanced solution will help Eisai accelerate data review and reconciliation by 80% New York – July 25, 2024 – Medidata, a Dassault Systèmes brand and leading provider of clinical trial...
Category: Clinical Trials, Other, Pharmaceutical
Posted: July 25, 2024
Advarra Brings Together Clinical Trial Patient Recruitment Activities to Centralize Visibility and Accelerate Enrolment
New capability provides sponsors and CROs holistic view of sites’ patient recruitment progress 24 July 2024 -- COLUMBIA, MD – – Advarra, the market leader in regulatory review solutions and...
Category: Clinical Trials, Drug Discovery, Other
Posted: July 24, 2024
CARBOGEN AMCIS Announces Two Successful FDA Inspections at its Manufacturing Sites in Neuland and Aarau, Switzerland
23 July 2024 -- Bubendorf, Switzerland -- Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of...
Category: BioManufacturing, Other, Pharmaceutical
Posted: July 23, 2024
Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis
22 July 2024 -- Melbourne, Australia -- Certa Therapeutics, a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 22, 2024
ViroCell Biologics signs Master Services Agreement with prominent NCI-designated cancer centre
MSA enables collaboration on full suite of ViroCell’s viral vector manufacturing services to accelerate the cancer centre’s clinical development of novel gene-modified cell therapies Agreement follows ViroCell’s successful GMP manufacture...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 22, 2024
Avallano releases ProtocolCopilot: Powering Clinical Research with AI-driven Protocol Assistance
16 July 2024 -- South Carolina, US -- Avallano is launching ProtocolCopilot, an innovative AI-driven clinical research protocol assistant designed to transform the way biopharmaceutical companies and clinical research sites...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: July 16, 2024
