
FDA approves Xolair (omalizumab) for the treatment of a rare skin disease known as chronic idiopathic urticarial.

FDA approves Xolair (omalizumab) for the treatment of a rare skin disease known as chronic idiopathic urticarial.

Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.

Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. The prefilled syringe formulation has been specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

Aesica has successfully completed the validation of its high capacity manufacturing facility in Queenborough, UK, for commercial production. The

The Pediatric Praziquantel Consortium has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant will be used to fund the Consortium's clinical development program of a newly developed praziquantel pediatric formulation targeted for use in very young children, including infants and toddlers, infected with schistosomiasis.

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

Charles River Laboratories to acquire CROs Argenta and BioFocus.

FDA approves Eliquis (apixaban) for DVT and PE in patients who have undergone hip or knee replacement surgery.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Catalent will recognize 80 years of softgel advancements with presentations at INTERPHEX.

Walker Barrier Systems builds eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

Almac expands technical, project, and operational resources in Asia.

To gain insights into the current trends of the biotechnology sector in the United Kingdom, Pharmaceutical Technology Europe spoke with Steve Bates, chief executive officer of the BioIndustry Association (BIA), the trade association for biotech companies in the UK.

$2.6 billion transaction combines Patheon and DSM Pharmaceutical to create CDMO, DPx.

HHS plan makes progress in ensuring availability of safe vaccines.

CPhI report shows R&D market diversifying with increased partnerships, mergers, and revenue sharing models.

Impact Analytical's facility in Michigan adds staff and instrumentation.

Beckman Coulter partners with Wyatt Technology to develop and market products for nanoparticle characterization.

Pfizer initiates nationwide voluntary recall of two lots Effexor XR and one lot Greenstone's Venlafaxine HCI.

Johnson Controls launches Integrated Laboratory Services for R&D facility operations and scientific productivity.

Agencies extend successful pilot program to further harmonization of QbD topics.

FDA approves the extended-release Bydureon Pen for the treatment of type 2 diabetes.

Novartis calls for more research to understand and find treatments for rare disease.

Waters celebrates ten-year anniversary of the ACQUITY UPLC System.

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

Conference sessions from PDA and PharmTech expand educational opportunities at INTERPHEX 2014.

The root cause of drug shortages is mismanagement of variation.

USP evaluates quality attributes for synthetic peptides.