BioPharm International Editors

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.

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.

The $1-billion deal includes select parts of Merck?s manufacturing site in Oss, The Netherlands and Sioux City, Iowa as well as 11 finished products.

The move doubles the CRO’s capacity in Europe.

The companies agree to jointly develop and promote MOR202, an oncology mAb in a deal potentially valued at more than $800 million.

Programs assist in the fast track of drugs for serious conditions.

Companies hope the collaboration will result in identifying potential new drug candidates using fewer rounds of design, synthesis, and testing.

A study shows significant improvement in public perceptions of clinical trial safety, trust in the motives of research professionals, and appreciation for trial volunteers.

Thermo Fisher Scientific Inc., has introduced a new-generation triple quadrupole liquid chromatography-mass spectrometry (LC-MS) platform.

Waters Corporation introduced the Waters SYNAPT G2-Si Mass Spectrometer, which integrates a third dimension of resolution and separation power.

Agilent Technologies Inc. introduced the MassHunter BioConfirm application, which allows users to rapidly create targeted screening methods.

Bruker Chemical and Applied Markets offers three LC-triple quadrupole (LC-TQ) mass spectrometers, the EVOQ Qube, the EVOQ Elite, and the EVOQ Elite ER.

The US Food and Drug Administration took action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers.

Thermo Fisher Scientific Inc. introduced the Thermo Scientific Orbitrap Fusion Tribrid liquid chromatography-mass spectrometry (LC-MS) system, which combines three mass analyzers.

Serelaxin, to treat acute heart failure, is the second Novartis drug to get new designation from FDA.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.