Development

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

Antibodies in research should be standardized and categorized using a barcode-like classification system, according to research published in Nature.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.

As ADCs move through the drug-development process, different analytical methods are often required.

Evaluating the assembly design process, manufacture, and use helps mitigate risk.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.

Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.

Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.

Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.

Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

The author presents opportunities and challenges in implementing the product lifecycle approach.

Ligand-binding assays are fundamental to characterizing biosimilars.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys

Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.