Drug Development

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.

Technological advancements can address the formulation and dissolution challenges of HPMC polymers.

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

If clinical trials are successful, roluperidone (MIN-101) will be the first treatment approved to treat symptoms of schizophrenia in the United States.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.

Under a new co-development license agreement, Boehringer Ingelheim and Inflammasome Therapeutics aim to develop novel therapies for retinal diseases.

Procarta Biosystems has received an award from CARB-X, potentially worth $9.2 million, for the development of antibiotic precision medicines.

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.

The new facility will handle clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction and will include stability chambers.

The drug will improve the treatment and prevention of invasive fungal infections.

The drug displayed improvement in progression-free survival and increased the time patients lived without disease progression or death by a median of 18.9 months.

In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.