Formulation and Drug Delivery

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

Shingrix represents a new, possibly better alternative to existing treatments.

The company has extended its presence in the US market to support its growing business in the region.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Innovation speeds discovery, drives down costs, and improves productivity.

When it comes to getting the best out of quality by design, timing is everything.

Considerations in selecting a dosage form for drug delivery to the lungs.

Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how-with the right knowledge and expertise-these challenges can be overcome.

Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.

QbD principles and strategic thinking can reduce the time required to optimize formulation. 

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.