News

EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.

Pfizer has announced plans to internally separate its commercial operations into three business segments.

A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

Bristol-Myers Squibb Company and Samsung BioLogics announced the companies have entered into a 10-year agreement.

Wyeth Pharmaceuticals has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by FDA.

Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer.

Adaptimmune has opened a Phase I/IIa ovarian cancer trial to evaluate its genetically engineered T cell treatment, with enhanced antitumor activity.

The report highlights a need for greater third party certification to ensure GMP vigilance.

Immunocore Limited has entered into a partnership with GlaxoSmithKline for multiple novel targets not addressable using antibody-based technologies.

A new end-user survey of more than 220 physicians and 650 patients by Frost & Sullivan finds that regardless of disease area, physicians select drug delivery methods that drive consistent patient compliance and effective outcomes.

UK government review will look for unnecessary regulatory burdens and inconsistencies and at guidance clarity.

Bashir Hansraj appointed as Global Technical Director, and David Ross and Sven Thomas appointed as business development managers

13 full members with expertise across the entire pharmaceutical supply chain.

Molecular Profiles has opened a new clinical manufacturing facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency.

Almac's Clinical Services business unit has expanded its service offering for dispensing and bottling solid dosage products.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.

The facility, which includes state-of-the-art formulation, analytical and synthetic laboratories as well as a customer training center, will focus on bioavailability enhancement and oral dosage formulations.

Fourth-generation biologics, with improved delivery and pharmacokinetics, will continue to drive an overall biologics industry that is already worth over $120 billion.

The new unit aligns existing modified-release and medication-delivery businesses of the company.

Research will focus on cancer and viral disease targets not addressable using antibody-based technologies.

Parexo Labs, a division of Azaya, launches as a new CDMO with an emphasis on nanotechnology and liposomal manufacturing.

The new organization hopes to enhance quality of life in Europe with advancements in biochemical engineering sciences.

Novartis and Biological E, a biopharmaceutical company based in India, have entered into an agreement that aims to deliver affordable and accessible vaccines for typhoid and paratyphoid A fevers to developing countries and thereby address the unmet medical need in endemic regions.

The core DNA-sequencing technology is based on the concept of passing a single strand of DNA through a nanometer-scale pore and reading out the sequence directly as it does so.

Seattle Genetics could potentially receive approximately $500 million in fees, milestones and royalties.

The partnership provides access to Xencor’s Fc engineering patents for monoclonal antibodies.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Europe prepares for inclusion of Croatia in EMA activities.