News and Press Releases
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...
Category: Clinical Trials
Posted: November 20, 2024
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PCI Pharma Services and ChiRhoClin Partner to Prevent Shortage of Critical Orphan Pancreatic Drug
Leading CDMO performing sterile drug manufacturing, lyophilization, testing/QA and packaging operations for mission-critical drug. 19 November 2024 – Philadelphia, PA, US – PCI Pharma Services (“PCI”) a leading global contract...
Category: BioManufacturing, Manufacturing and Packing
Posted: November 19, 2024
SEKISUI Completes £15.7 Million Expansion in cGMP Biopharma CDMO Capacity
Growth of UK facility will enable clinical-grade manufacturing of drug substances for range of biopharmaceutical products 14 November 2024 – Burlington, MA, USA – SEKISUI Diagnostics’ microbial CDMO business announces...
Category: Manufacturing and Packing
Posted: November 19, 2024
LINDIS Biotech Signs Licensing Agreement with Pharmanovia for the Commercialization of Catumaxomab
Catumaxomab received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) at its October 2024 meeting and if approved catumaxomab will be the only approved...
Category:
Posted: November 19, 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
Sanofi wins appeal against negative Final Draft Guidance for its standard-of-care multiple myeloma combination therapy opening the door for a third NICE Committee Meeting
· Sanofi welcomes the decision as recognition from the National Institute for Health and Care Excellence (NICE) that there are challenges with the current framework for assessing and funding innovative...
Category:
Posted: November 19, 2024
Coveris MediFlex – a strong brand for medical packaging
11 November 2024 – Vienna, Austria – Following extensive investments in its medical production facilities, Coveris is now consolidating its capabilities and high-class medical offerings under one brand name: MediFlex....
Category: Manufacturing and Packing
Posted: November 18, 2024
Tower Cold Chain Launches Carbon Calculator to Boost Sustainable Logistics for Customers
13 November 2024 – Tower Cold Chain has introduced its own Carbon Calculator to help customers improve the sustainability of their logistics operations. The new Carbon Calculator was co-developed with...
Category: Logistics
Posted: November 18, 2024
Unit A, Total Park, Station Road, Theale, Reading, Berkshire RG7 4PN, UK
Sphere Fluidics strengthens global commercial teams and establishes direct sales and support channel in North America
Significant expansion of global commercial leadership team led by new CEO, Dale Levitzke, to address global demand for the Cyto-Mine Chroma platform 14 November 2024 – Cambridge, UK – Sphere...
Category: BioManufacturing
Posted: November 18, 2024
The Jonas Webb Building, Babraham Research Campus, Babraham, Cambridge CB22 3AT, United Kingdom
Barinthus Bio Announces Results From Ongoing Phase 2b Chronic Hepatitis B Trial, Including Achievement of Functional Cure and HBsAb Seroconversion
Eight participants achieved HBsAg loss at any time Two participants met criteria for functional cure Two participants who discontinued NUC therapy seroconverted to HBsAb positivity. 15 November 2024 -- Oxford,...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: November 15, 2024
The results are in – we’re one step closer to a universal COVID-19 vaccine
12 November 2024 – London, UK –The encouraging findings of recent preclinical trials for a novel, broad-spectrum COVID-19 vaccine have now been published in Cell. The vaccine candidate was produced using...
Category:
Posted: November 12, 2024
Ingenza Ltd, Roslin Innovation Centr,e Charnock Bradley Building, Easter Bush Campus, Bush Farm Road, Roslin, EH25 9RG, UK
French Biotech Company AdipoPharma Secures Funding to Initiate Clinical Trials for its first-in-class compound for Insulin Resistance
Global Investments Pave Way for Breakthrough Treatment for Type 2 Diabetes 11 November 2024 -- Strasbourg, France -- AdipoPharma, a biotech company headquartered in France with offices in the US...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 11, 2024
DNA analysis of Parsortix-enriched CTCs and ctDNA provides complementary information in NSCLC patients treated with AstraZeneca’s osimertinib
The addition of CTC-DNA analysis to clinical trials could identify patients developing treatment resistance prior to disease progression CTC analysis identifies druggable targets which could be used to inform combined...
Category: Biotechnology, Clinical Trials
Posted: November 11, 2024
MMS Named a Finalist in the 2024 Fierce CRO Awards for Leadership in Regulatory Compliance
Zero refusals to file and a SOUL mindset helped solidify the honor 8 November 2024 -- Michigan, US -- MMS, a leading data and regulatory focused clinical research organization (CRO),...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 8, 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
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