Development

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Choosing the optimal protein expression vector depends on strain, promoter, and a number of other factors.

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

Ethylene vinyl acetate (EVA) drug-release technologies are explored.

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

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.