BioPharm International Editors

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly ten 10 years in the position.

ANGUS reveals ANGUS Life Sciences as a new company division that will serve pharmaceutical, biotechnology, and agriculture markets.

PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.

The companies say the acquisition will assist in expediting the clinical development of RhoNova, a potential treatment targeting rhodopsin-linked autosomal dominant retinitis pigmentosa.

With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.

The company will showcase workflow solutions for sample prep and data analysis.

The investment includes facility upgrades and expansion of development capabilities.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

Clinical trials of Eli Lilly’s ixekizumab showed the drug displayed clinically meaningful improvements in patients with moderate-to-severe plaque psoriasis.

The inspection confirmed that the facility was compliant with GMP guidelines.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.

The new group is made up of over 15 scientists who formerly worked in GSK's computational biology and genetics departments

The program is intended to provide support to ongoing efforts in rare disease product development.

The Eppendorf and Science Prize for Neurobiology is a research prize of $25,000, given to young scientists for their contributions in neurobiology.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

The collaboration is part of Innovate UK’s competition for the development of regenerative medicines.

Under the agreement, Caribou has granted IDT worldwide rights to commercialize CRISPR-Cas9 reagents under Caribou’s intellectual property.

Robert Califf has been confirmed by the US Senate as FDA commissioner.

Curida entered into a partnership with René Bommer, PhD, founder and owner of pharmAccel Consulting.

The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.