Development

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

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.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.

When using media supplements in biologics, it is important to have a key understanding of both the supplement and the base medium to ensure high titer and stability.

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

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with BioPharm International about collaborative success strategies for biopharm companies.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

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.