Recipharm partners with Ahead Therapeutics to develop rare autoimmune disease therapy

Global contract development and manufacturing organisation (CDMO) Recipharm is partnering with Ahead Therapeutics to develop a ground-breaking treatment for a rare autoimmune disease, myasthenia gravis. Ahead Therapeutics is a Spanish start-up biotech company, using proprietary technology to develop treatments for different autoimmune disorders. Under the agreement, Recipharm will provide analytical and process development capabilities to support toxicology studies, as […]

Early Phase Clinical Trials in Immunology

Immunology, the intricate study of our body’s defense mechanism, has been at the epicenter of several groundbreaking medical research studies. As we delve deeper into understanding our immune system, new potential treatments and drugs emerge. But before they can make a mark in real-world medical scenarios, they undergo the crucible of clinical trials. Navigating this […]

MHRA Grants Rentschler Biopharma cGMP Compliance Certificate

After undergoing an inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA), Rentschler Biopharma SE’s UK facility for advanced therapy medicinal products (ATMP) has been granted a Manufacturing Compliance Certificate in accordance with current good manufacturing practice (cGMP). This certification signifies that the contract development and manufacturing organization (CDMO) located within the Cell […]

New Measures By The European Commission To Empower SMEs

Small and medium-sized enterprises (SMEs) often encounter unfair competition while conducting business in Europe. To rectify this issue, the European Commission (EC) has introduced new measures through SME Relief Communication. These measures offer immediate relief, enhance long-term competitiveness, and promote equity within the European Single Market’s business landscape. This initiative is designed to cater to […]

CPHI Annual Report Forecasts A Pharmaceutical Revolution

The initial findings from the CPHI Annual Report for 2023, which offers insights from 250 global pharmaceutical companies, indicate that artificial intelligence (AI) is poised to revolutionize every aspect of the pharmaceutical industry, from drug discovery to drug development, within the next two years. According to the data, it is projected that by 2030, more […]

Innovations And Digitalization In The AAV Manufacturing

The Cell and Gene Therapy Catapult is embarking on a two-year project in collaboration with two other organizations, namely contract development and manufacturing organization (CDMO) Rentschler Biopharma and Refeyn Ltd. Their objective is to enhance the manufacturing process of adeno-associated viruses (AAV) used in gene therapies by incorporating automated and digital process analytical technologies (PAT). […]

FTC And Amgen Reach Agreement On Horizon Therapeutics Deal

As per the US Federal Trade Commission (FTC), Amgen is prohibited from using its drug portfolio to unfairly disadvantage its competitors in the industry. The biopharmaceutical company will need to obtain prior approval before acquiring related products. The FTC has agreed with Amgen Inc. to address the potential harm to competition that could arise from […]

The Medicines Manufacturing Skills Initiative By The UK

The UK government dedicates £5.5 million towards establishing a Medicines Manufacturing Skills Centre of Excellence. This center aims to bolster the pool of skilled individuals in the UK’s life sciences sector, fostering innovation and enabling the country to respond to future health crises effectively. It will leverage existing infrastructure and industry best practices to provide […]

CordenPharma Inaugurates Increased Peptide Production of the Largest Worldwide SPPS Manufacturing Plant to Meet Growing Market Demand

Following the signature of a multi-year large scale peptide manufacturing agreement earlier this year, CordenPharma is pleased to announce the inauguration of increased commercial peptide production capacity with newly-upgraded facilities at CordenPharma Colorado, the largest Solid-Phase Peptide Synthesis ( SPPS ) Manufacturing facility worldwide . After kicking off capital investments in early 2023, CordenPharma successfully […]

Medac GmbH Advances Pharmacovigilance Technology for Safety Monitoring of its Drugs with ArisGlobal Solutions

ArisGlobal, a market-leader in global drug development technology solutions, announced that medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, has chosen LifeSphere Safety to modernize its drug safety processes. Precise, patient- and population-specific analysis is crucial for minimizing treatment risks for patients and thus supports the […]