Drug Development

Articles

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

FDA Looks to Modernize Generic Drug Labels

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

FDA Approves Celltrion and Teva’s Biosimilar to Rituxan

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

GSK and TESARO Reach Acquisition Agreement

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie’s Humira worldwide.

Pfizer Gets Global Patent License for AbbVie’s Humira

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery. 

Developing and Manufacturing Transdermal Patches

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

Spray Film Provides Alternative to Patches

Drug and adhesive formulation are crucial to the development of microneedle patches for pharmaceutical transdermal delivery systems. 

Manufacturing Considerations for Transdermal Delivery Systems

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Antibody-based drugs offer new mechanisms of action and greater specificity.

Fighting Bacterial Resistance with Biologics

Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.

Autoinjector Training May Lead to Patient Adherence

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products. 

Formulation and Drug Delivery