News and Press Releases
Puma Biotechnology Announces Initiation of ALISCATM-Breast1 Phase II Trial of Alisertib in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
20 November 2024 -- California, US -- Puma Biotechnology, Inc, a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCATM-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 20, 2024
Recipharm’s full range Oral Solid Dosage (OSD) capabilities meet growing industry demands
Full range OSD development and manufacturing capabilities from orphan drugs to blockbusters High potency manufacturing capabilities expansion Introduction of ReciPredict platform to accelerate product development and de-risk tech transfer API...
Category: Manufacturing and Packing
Posted: November 19, 2024
Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma
If approved, daratumumab will become the first treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: November 8, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Bespak and Orbia Fluor & Energy Materials unite to accelerate transition to climate-friendly inhalers
Collaboration aims to speed the commercialisation of low global warming potential pMDIs utilising Orbia Fluor & Energy Materials’ Zephex® 152a propellant at Bespak’s Holmes Chapel site 6 November 2024 –...
Category: Drug Delivery, Manufacturing and Packing
Posted: November 6, 2024
Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024
New Phase 1/2 data support the potential of our CAR T-cell therapy candidates, GLPG5101 and GLPG5201, in addressing unmet needs for patients with poor prognoses Our innovative decentralized cell therapy...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 5, 2024
53Biologics Awarded Best Company in Biotechnology Innovation at Farmaforum
This award acknowledges the company’s groundbreaking work in microbial expression systems and its ongoing commitment to delivering cutting-edge biotechnological solutions for the global market. 53Biologics, a Contract Development and Manufacturing...
Category: Biotechnology
Posted: October 30, 2024
PCI Pharma Services Wins Supply Chain Excellence Award for Groundbreaking Digital Platform to Manage Clinical Trials and Commercial Lifespans
Leading CDMO’s pci | bridge enhances supply chain visibility and reduces time spent on manual activities such as forecasting, inventory management, reporting, supplier management and document sharing. 30 October 2024...
Category: Biotechnology, Clinical Trials, Drug Discovery, Logistics
Posted: October 30, 2024
Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant...
Category: Clinical Trials, Drug Discovery
Posted: October 24, 2024
Rentschler Biopharma announces largest single investment at its headquarters in Germany
Construction of a new buffer media facility in Laupheim Largest investment in the German site; project duration of approx. three years Continuous modernization, automation, and digitalization of the site. 24...
Category: Biotechnology, Manufacturing and Packing, Other
Posted: October 24, 2024
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible
Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent...
Category: Drug Discovery
Posted: October 23, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Publication Demonstrates Potential for Multi-Marker CTC Profiling in Early Prostate Cancer
Parsortix enriched CTCs detected at high rates in localised disease Multi-marker profiling of CTCs could support development of targeted therapies and help stratify patients in clinical trials 17 October 2024...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 17, 2024
HUTCHMED Announces that TAGRISSO plus ORPATHYS demonstrated high,clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial
New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer MET is a common biomarker in this setting for patients who develop resistance...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 16, 2024
Ingenza announces move to purpose-built facilities to expand fermentation and research capacity
1 October 2024 – Roslin, Scotland – Ingenza – a world-leading contract research, development and manufacturing organisation (CRDMO) and technology accelerator – is delighted to announce its plans to relocate...
Category: BioManufacturing
Posted: October 14, 2024
Ingenza Ltd, Roslin Innovation Centr,e Charnock Bradley Building, Easter Bush Campus, Bush Farm Road, Roslin, EH25 9RG, UK
3PBIOVIAN strengthens its leadership team with the appointment of a Business Development Director for Advanced Therapies
This strategic hire will further solidify 3PBIOVIAN’s position as a leading CDMO in the development of advanced therapies and enhance its international commercial team October 9, 2024 – Noáin, Spain–...
Category: BioManufacturing
Posted: October 11, 2024
Mosaic Therapeutics appoints Dr Barry Davies as CSO
Former AstraZeneca Senior Director, Global Project Leader adds significant experience and expertise to leadership team Appointment will drive further development of Mosaic’s targeted oncology combination therapies pipeline and platform. 7...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 7, 2024
Mosaic Therapeutics Wellcome Genome Campus Cambridge CB10 1DR
