News

The move doubles the CRO’s capacity in Europe.

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

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.

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

The Onyx board of directors rejects $120-per-share proposal as significantly undervaluing the company.

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

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.

A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.

USP focuses on building worldwide partnerships in standards-setting activities.

Pharma and biotech companies, with the rest of the health care industry, must face change.

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

As the dreaded patent cliff continues to haunt the pharmaceutical industry, some companies are resorting to desperate measures to delay generic drug entry into the market.

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.

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

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

The US Food and Drug Administration has approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older.

Mettler Toledo's global weighing standard, GWP, can help pharmaceutical manufacturers meet the new requirements of USP Chapter 41 and Chapter 1251.

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

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

Hermes Pharma announced that the company completed a successful inspection by the US FDA of its production facility located in Wolfratshausen, Germany.

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

The FDA approved Brisdelle (paroxetine) to treat moderate to severe hot flashes.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended 10 new medicines for approval, including the first two monoclonal antibody biosimilars, and a new advanced therapy medicine.

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

Eisai has launched a new dry syrup formulation of its Alzheimer's disease treatment Aricept (donepezil hydrochloride) in Japan.

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

The move is part of a strategy to cultivate innovation in key regions.

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

Entries open to any company across three categories - formulation, process development and best packaging.