Drug Delivery

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.

Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

The company plans to reformulate injectable products to make them into inhaled and intranasal medications.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

A new consortium involving Arecor, FUJIFILM Diosynth Biotechnologies and the Center for Process Innovation will focus on formulation innovation as a way to improve downstream processing and reduce biopharmaceutical cost.

The company presented a portfolio of new products during the meeting in Madrid.

This article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

The collaborative effort will be focused on fully humanized antibodies.

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Gene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.