News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The partnership revolves around Muna Therapeutics’ technology platform, which employs a spatial multi-omics approach to identify and validate new drug targets for neurodegenerative diseases.
The two anti-TL1A antibodies are being tested in healthy people, with the first participants dosed.
The UK cell therapy biotech will now advance its first candidate cell therapy to clinical trials for treatment of liver disease.
The new company focuses on producing components needed to manufacture RNA-based therapies for which there is increasing demand.
With a new investment in its two manufacturing sites in Ireland, Eli Lilly continues implementing the largest expansion program in the company’s history.
New data from the QWINT clinical trial may get Eli Lilly closer to bringing a once-weekly insulin injection to the US, following the FDA’s rejection of Novo Nordisk’s own weekly insulin formulation earlier this year.
BeiGene, a global oncology company, has announced the opening of its flagship US facility, which will expand the company’s biologics manufacturing capabilities and clinical research and development activities.
In the rapidly evolving field of pharmaceuticals, the development of parenteral drugs and bioconjugates presents unique challenges and opportunities.
The oversubscribed fundraising will enable Third Arc Bio to enter the clinic with multiple programs in 2025.
b
Alvotech and Stada launch Stelara biosimilar following European approval earlier this year and expiry of exclusivity rights on the original molecule.
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.
As a strategic brand consultant at ramarketing, Laura combines her extensive background in clinical research with strategic leadership and creative expression.
Roche’s recent $2.7 billion acquisition of Carmot Therapeutics is paying off, with positive results for new oral GLP-1 receptor agonist.
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.
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Results from the NEST-IN1 trial have shown that HilleVax’s vaccine candidate was ineffective at preventing norovirus infections in infants.
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.
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.
ELRIG UK, a leading organization in the drug discovery community, has partnered with The Protein Society (TPS) to host a groundbreaking conference on ‘Protein Sciences in Drug Discovery’.
Alnylam’s experimental drug vutrisiran has shown promise for the treatment of transthyretin amyloidosis (ATTR) in a phase 3 clinical trial.
Results from a phase 1/2 clinical trial revealed that PolTREG’s regulatory T cell (Treg) therapy, PTG-007, was able to restore insulin secretion in children with type-1 diabetes.
Director of cell and gene therapy R&D at Lonza, this week's inspiring female is Inbar who we spoke to about her passion for discovering the future and mentor support sparked her early interest in biology and informed her journey of resiliency.
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.
In the wake of escalating tensions between the United States and China, the Biden Administration is intensifying its strategic focus on biosecurity.
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.
Alchemab Therapeutics, an antibody discovery company focused on identifying antibodies from individuals resilient to disease, has been awarded a grant of $595,000 by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to propel its Parkinson’s...
Darren Leva, chief business officer at Belgium-based CDMO Exothera, is at the forefront of the company’s efforts in advancing mRNA-based therapies.
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.
With a rich background in biochemistry and extensive experience in the pharmaceutical industry, Himanshu Gadgil shares insights into Enzene's journey, its innovative approach to biosimilars.
Verona Pharma has revealed its ongoing preparations for the potential launch of ensifentrine in the US market, slated for the third quarter of 2024 pending FDA approval, expected by June 26, 2024.
As the BIO International 2024 trade show approaches, industry insiders anticipate a significant focus on partnership discussions, driven by the pressing financial needs of biotech companies rather than the new BIOSECURE act.
Ahead of Bio International, we had an conversation with Bora Pharmaceuticals to get a glimpse of what they have in store for the event.
EXO Biologics, a clinical-stage biotech specializing in exosome-based therapies, recently announced the successful raising of €16 million in Series A funding.
Clinical development analytics company Phesi has released a new analysis of global oncology trial investigator sites ahead of attending ASCO 2024 – the American Society of Clinical Oncology’s annual meeting.
Innovent Biologics has revealed encouraging phase 3 (DREAMS-2) findings for mazdutide, showcasing its superiority over dulaglutide in managing glycemic levels among patients with type 2 diabetes (T2D) in China.
Peter Benton is president and CEO of Worldwide Clinical Trials, a full-service global CRO. We spoke with him about his insights into recent trends and factors influencing biopharma investment decisions.
Oxford BioDynamics, a biotech company specializing in precision medicine tests via the EpiSwitch 3D genomics platform, has partnered with the Goodbody Clinic, a provider of private health testing services.
Cartherics, a biotechnology company specializing in immune cell therapies for cancer, has announced the granting of its second European patent.
A new report from Graphite Digital has revealed that 36% of senior leaders in pharma agree that funding is the biggest barrier to digital adoption and transformation, despite increasing spend.
At the ASCT 2024 conference a few weeks ago, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, highlighted a crucial issue in the future of clinical trials.
Endeavor BioMedicines, a clinical-stage biotech company, has announced promising phase 2a trial results for its lead investigational candidate, ENV-101.
Proteins present in the blood may be able to predict a person's risk of developing cancer more than seven years before they are diagnosed with the disease, according to new research.
Oxford BioDynamics (OBD) and King’s College London (KCL) have partnered to use OBD’s EpiSwitch technology to identify patients at risk of rheumatoid arthritis (RA) who can benefit from abatacept treatment.
Closed Loop Medicine, a techbio company specializing in personalized drug-plus-software therapies, and Pharmanovia, a global pharmaceutical firm known for rejuvenating established medicines, have initiated their OptiZest study.