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.
AbbVie has announced that the Scottish Medicines Consortium (SMC) has approved Tepkinly (epcoritamab) for adults with diffuse large B-cell lymphoma (DLBCL) who have not responded to or have relapsed after at least two prior treatments.
CordenPharma, a global CDMO manufacturing complex drug substances and lipid nanoparticles (LNPs), has signed a partnership agreement with Certest, a Spanish company specializing in drug delivery and API synthesis.
Nucleus RadioPharma, a leading player in the development, manufacturing, and supply chain management of radiopharmaceuticals, has announced a significant milestone with the closing of a Series A extension round, featuring a new investment from AstraZeneca.
As the DIA conference in San Diego approaches, Outsourcing Pharma secured an exclusive preview with François Torche, chief product & technology officer and co-founder of CluePoints
As DIA's 60th anniversary at the annual event in San Diego approaches, OSP is excited to bring you insights from Advarra, a leader in advancing clinical research.
Get ready for a big reveal at the DIA conference in San Diego as GiftHealth introduces its latest AI-enabled features designed to revolutionize patient care.
As the anticipation for the 60th DIA annual meeting reaches a fever pitch, eyes should be on Qinecsa, the latest breakthrough in clinical research technology.
At the DIA 2024 Global Annual Meeting, Phastar iwill be proud to join a diverse group of stakeholders from industry, regulatory bodies, academia, and patient communities.
Stella Vnook has founded several biotech companies, including Oral BioLife, a biotechnology firm specializing in pioneering therapies for dental diseases.
In what could be a significant leap for scientific research and biopharmaceuticals, DefiniGEN and Atelerix have unveiled a new collaboration that allows in vitro cell models to be shipped internationally without freezing or cryopreservation.
