Patrick Lavery

The next-generation IRO platform was found to significantly outperform the legacy Prodigy system, showing improvements in cell growth, CAR+ cell yield, and overall efficiency.

The announcement of the pairing comes several months after Adare Pharma Solutions said it would upgrade several of its facilities, including in Milan, Italy, where the 3D printing operations will be located.

Vectura’s expertise in the field includes formulation and device development for dry powder inhalers and pressurized metered dose inhalers, among other products and services.

The collaboration is designed to combine NanoVation Therapeutics’ lipid nanoparticle technology for RNA delivery to cells outside the liver with Novo Nordisk’s knowledge of cardiometabolic and rare disease R&D.

The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.

The critical APIs that this funding will contribute to are used in the treatment of asthma, diabetes, and anxiety disorders.

Descon Conveyor Systems is joining Pacteon’s portfolio, and its product will be shown alongside those from Schneider Packaging Equipment and Phoenix Stretch Wrappers.

Seventeen biologics and nine tides—five peptides and four oligonucleotides—were approved in 2023 alone, with further growth predicted.

Among the design features of the machine is software-based tracking that is meant to ensure that products that are temperature-sensitive do not exceed their time limit in the solution.

The approach makes use of clinical mass spectrometers that are already available in hospitals around the world.

This is the company’s largest single investment in the Sweden Biomanufacturing Center, in Södertälje, which opened in 2021.

PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training.

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

In a 24-week study of patients with PAH, six-minute walking distance improved by an average of 40.8 meters, and risk of death or clinical worsening was reduced by 82%.

The collaboration builds on Novartis’ acquisition of Chinook Therapeutics just over a year ago.

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

The combination of Opdivo plus Yervoy is already established as a second-line treatment for patients with advanced hepatocellular carcinoma.

The International Coalition of Medicines Regulatory Authorities’ new Collaborative Hybrid Inspection Pilot program allows a CDMO to gain approval from multiple countries simultaneously, as opposed to separately phased inspections from different corners of the globe.

Fasenra, which has been approved since 2019 in the United States in a pre-filled, single-use auto-injector form that can be administered either in a doctor’s office or at home, is now approved in China for age 12 and up.

Approximately 15% of all lung cancers diagnosed in the US are of the small-cell variety, and of those, 70% are considered extensive-stage.

NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study.

The agreement specifies that Nanoform will provide non-GMP nanomaterial to Takeda for in-vivo studies, the first results of which should be delivered by early 2025.

A Phase III study showed that 62% of patients given Livdelzi achieved the primary endpoint of composite biochemical response after 12 months, compared to 20% of participants taking placebo.

National Institutes of Health’s National Institute of Allergy and Infectious Diseases collaborated with the University of Sciences, Techniques and Technologies of Bamako, Mali to conduct the trials.

Imfinzi may be used alone, or with chemotherapy in tandem with the other approved treatment, Lynparza.

Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH.

AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries.

The 94.3% efficacy of the Octapharma product was just a shade ahead of the 94.2% measured in a comparative product, Kcentra.

The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year.