Formulation

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Gene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

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.

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.

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.

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.

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.

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

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

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.

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

Ligand-binding assays are fundamental to characterizing biosimilars.

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

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

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.