News and Press Releases
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, will become the first therapy targeting FGFR alterations in patients with metastatic urothelial carcinoma, one...
Category: Clinical Trials
Posted: September 12, 2023
Signum Surgical Completes Clinical Trial for BioHealx
Galway based company compiling data for submission of a De Novo classification request to US FDA Novel surgical option for the treatment of anal fistula, a painful and debilitating colorectal...
Category: Clinical Trials
Posted: September 12, 2023
The company promotes the development of digitisation solutions in GMP environments and process automation for the pharmaceutical industry
At Farmaforum, Telstar to promote the new software platform Ip6 for supply chain & logistics management 12 September 2023 -- Barcelona, Spain -- Within the framework of FarmaForum 2023 (Madrid,...
Category: Logistics
Posted: September 12, 2023
Av. Font i Sagué, 55, Tecnològic Orbital 40, 08227 Terrassa, Barcelona, Spain
MODERNA RECEIVES US FDA APPROVAL FOR UPDATED COVID-19 VACCINE
Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86 Updated vaccine to be available in pharmacies and care settings across the US in the...
Category: Clinical Trials
Posted: September 12, 2023
Janssen Submits MA Application to the European MedicinesAgency Seeking Approval of Erdafitinib for the Treatment of Patients with LocallyAdvanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factorreceptor (FGFR) tyrosine kinase inhibitor, will become the first therapy targeting FGFRalterations in patients with metastatic urothelial carcinoma, one of Europe’s...
Category: Clinical Trials, Drug Discovery
Posted: September 8, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Thermo Fisher Scientific and National Minority Quality Forum Collaborate to Make Clinical Research More Accessible to Historically Underserved Communities
7 September 2023 -- Massachusetts, US -- Thermo Fisher Scientific, the world leader in serving science, and the National Minority Quality Forum (NMQF), an independent not-for-profit research and education organisation,...
Category: Clinical Trials
Posted: September 7, 2023
Phesi and Krystelis collaborate to launch new Diversity, Equity and Inclusion Data Service for clinical development
New Diversity, Equity, and Inclusion (DEI) Data Service will harness data from 70 million patients to enable sponsors to create more diverse trials, reduce protocol amendments and meet new FDA...
Category: Clinical Trials
Posted: September 7, 2023
Certara Simcyp Group Awarded Two New Grants from US FDA
Programmes focus on use of physiologically-based pharmacokinetic (PBPK) modelling for demonstrating virtual bioequivalence and predicting drug absorption of topical formulations 29 August 2023 -- New Jersey, US -- Certara, a global...
Category: Clinical Trials
Posted: September 4, 2023
Vetter earns Frost & Sullivan’s Customer Value Award for the third time
Identified as best-in-class CDMO in global biopharmaceutical aseptic fill-and-finish services Best practices in operational efficiency and customer processes Unmatched customer service experience Recognition of strong financial performance...
Category: Manufacturing and Packing
Posted: August 30, 2023
dnata to Deliver AI-powered Solutions to Drive Innovative Cargo Services in Singapore
Partnership with Speedcargo to transform airfreight operations Etihad Cargo becomes first customer to take advantage of technology in Singapore ‘Cargo Eye’ and ‘Assemble’ maximise flight cargo capacity, improving operational efficiencies...
Category: Logistics
Posted: August 29, 2023
Polpharma Biologics announces FDA approval of Tyruko – first and only approved biosimilar to Tysabri for relapsing forms of multiple sclerosis
25 August 2023 – Amsterdam, The Netherlands – Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars, announced today that the U.S. Food and Drug...
Category:
Posted: August 25, 2023
InnovatePharmaHealthcare 2023 is Returning to the Heart of London on the 11th and 12th of September
Featuring four outstanding conference programmes covering the latest innovations, developments, and opportunities in pharma’s digital transformation journey, implementing decentralised trials, sustainable patient-centric trials, accelerating sustainable healthcare transformation, and integrating a...
Category: BioManufacturing, Biotechnology, Clinical Trials
Posted: August 25, 2023
NIH and Exothera collaborate to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US
16 August 2023 -- Maryland, US and Jumet, Belgium -- The National Institutes of Health (NIH), the US’s medical research agency, selected Exothera, a full-service Contract Development and Manufacturing Organisation...
Category: Other
Posted: August 23, 2023
ETIHAD CARGO RAMPS UP CARGO CAPACITY FOR CHINA
Etihad Cargo now provides additional cargo capacity via a weekly freighter service to Guangzhou. The carrier operates ten freighter services per week to mainland China, including weekly flights to Guangzhou...
Category: Logistics
Posted: August 23, 2023
New Educational Initiative, Clinical Trials For All,to Drive More Understanding, Participation and Diversity
22 August 2023 -- Nebraska, US -- Only 59% of Americans know about clinical research. 91% of Americans have never been invited to participate and Black/African and Hispanic/Latino Americans are...
Category: Clinical Trials
Posted: August 22, 2023
