In a candid interview at the DIA conference, James Bellamy, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape of pharmacovigilance (PV) technology.
As advanced therapies drive increasing market consolidation, the US giant Agilent Technologies has acquired the Canadian contract development and manufacturing organization (CDMO) BIOVECTRA for $925 million.
When she was young, Suzanne used to love hearing her father, a cardiologist, talking to his colleagues on the phone about patients and the care they needed.
Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.
Demand for biosimilars is booming, with no hints of slowing down as the number of biosimilars getting approved keeps growing. Here are all the biosimilars that have received approval in 2024 to date.
Samsung Bioepis Co., Ltd. announced yesterday (July 23) that the US Food and Drug Administration (FDA) has approved Epsyqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab).
In a bid to make biologic treatments more accessible to patients, Boehringer Ingelheim is harnessing the reach and scale of the prescription savings platform GoodRx to provide its Humira biosimilar adalimumab-adbm at a low price.
The fundraising will support the development of the company’s technology platform for silencing RNA (siRNA), which has the potential to enable dosing patients every six months to treat a wide range of conditions.
The contract development and manufacturing organization (CDMO) arm of the Israeli company Pluri will deploy automated and 3D cell expansion technology to produce cell therapies developed by compatriot firm Kadimastem.
Ionis Pharmaceuticals antisense therapy for Angelman syndrome achieved good early safety and efficacy results and the company now plans to advance the therapy to phase 3.
Dr. Antonella Favit-VanPelt, a distinguished neurologist, has had a lifelong passion for understanding the 'why' behind sickness, ignited by her childhood curiosity.
As a strategic brand consultant at ramarketing, Laura combines her extensive background in clinical research with strategic leadership and creative expression.
Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry – a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward...
CordenPharma, a US-based contract development and manufacturing organization (CDMO), will be making a €900 million investment over the next three years into expanding its peptide technology platform at its US and Europe sites.
A gene therapy being developed by Lexeo Therapeutics to treat cardiomyopathy caused by Friedreich ataxia, a rare neurodegenerative genetic disease, has achieved good interim results in a phase 1/2 trial.
Novo Nordisk will have to fulfill requests from the FDA regarding the manufacturing process and the indication before it can receive approval for insulin icodec.
The contract development and manufacturing organization (CDMO) Rentschler Biopharma has doubled its Current Good Manufacturing Practice (cGMP) global production capacity for complex therapies as its new production line kicks into action in the US.
During her teenage years, Dr. Jasmina Jankicevic harbored a passion for researching and advocating improved methods to maintain health and well-being for both children and adults.
Thermo Fisher’s cutting-edge ultra-cold facility in Bleiswijk, Netherlands, aims to accelerate advanced therapies development by offering comprehensive cold and ultra-cold services.
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Andelyn Biosciences, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been chosen by UMass Chan Medical School to manufacture clinical-grade AAV9-CSA vector using its suspension AAV Curator Platform...
Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.
As the industry continues its fascination with antibody-drug conjugates (ADCs), UK startup Myricx Bio heralds European biotech’s biggest Series A round this year.
CureVac has signed a new licensing agreement with GSK shortly after announcing the decision to reduce its workforce by 30% and refocus its research and development priorities.
Eli Lilly has finally achieved FDA approval for its monoclonal antibody Alzheimer’s therapy donanemab, bringing new competition to the field for Eisai and Biogen.
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Hot on the heels of last year’s EU approval of Hemgenix, the first gene therapy for the blood disorder hemophilia B, the UK and Denmark are the latest European nations to take steps to pay for the treatment.
The US FDA has delayed approval of Rocket Pharmaceuticals’ gene therapy for treatment of a rare immune condition known as leukocyte adhesion deficiency, citing a need for more information about the manufacturing process.
As Saudi Arabia seeks to make its healthcare system more cost-efficient, the private equity firm TVM Capital Healthcare is betting $35 million on the Saudi Arabia-based bio-generics provider Boston Oncology Arabia.
Once monthly treatment with Novo Nordisk’s antibody treatment reduced annual treated bleeds to zero in 95% previously untreated people with hemophilia A.
Yesterday (June 24) Novo Nordisk unveiled plans to invest $4.1 billion (approximately €3.8 billion) in a new manufacturing facility in Clayton, North Carolina.
The Seattle-based company Cyrus Biotechnology has spun out Levitate Bio to offer artificial intelligence (AI)-based protein design software to customers across the biopharma space.
As investors and big pharma pile on developers of antibody-drug conjugates (ADCs), Bright Peak Therapeutics has attracted $90 million based on the promise of a related type of technology called immunoconjugates.
Alvotech of Iceland and STADA Arzneimittel of Germany have extended an existing partnership to co-develop a clinical-stage biosimilar for Prolia and Xgeva, Amgen’s therapies for bone conditions based on the antibody drug denosumab.
In spite of their potential to tackle cancer in the long term, CAR-T cell therapies face challenges in terms of pricing, manufacturing and being limited to blood cancer.
Keen to accelerate its drug development, the Japanese pharmaceutical group Kyowa Kirin will pump up to $530 million into building a biologics manufacturing plant in North Carolina, US.
