News

A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Novartis Ilaris, an interleukin-1 beta inhibitor, treats active system juvenile idiopathic arthritis.

Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.

Sobi's application for Orfadin oral suspension has been validated by EMA.

Hospira has initiated a voluntary nationwide user-level recall of Aminosyn II, due to a foreign particle included in the injection port.

BioReliance updates Big Blue Mouse Assay service to meet OECD test requirements.

The new director general has stepped into the European generic and biosimilar medicines industries at a challenging time when the trade association is facing numerous priority issues on the European agenda.

The new subcutaneous formulation of Herceptin can be administered six times faster than the standard intravenous formulation.

FDA has issued a safety alert after a patient with multiple sclerosis in Europe developed a rare and serious brain infection known as progressive multifocal leukoencephalopathy following treatment with Gilenya (fingolimod).

There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

The California State Assembly becomes the latest state to specify requirements allowing substitution of biosimilars.

Akebia appoints new president and CEO.

A new standard from the International Society of Automation addresses information technology security solutions for manufacturing applications.

Johnson & Johnson completes acquisition deal with Aragon Pharmaceuticals.

Pharmaceutical Product Development has acquired patient-recruitment contractor Acurian.

Cubist issued a voluntary recall of four lots of vials due to the presence of particulate matter.

ATCC creates Biomaterial Contributor Network to assist the research community.

James Stewart named CIO of Merck KGaA.

Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.

A Sanofi Pasteur flu-vaccine trial in adults 65 years of age and older meets a primary endpoint for superior efficacy.

The Russian pharmaceutical company PharmaStand finalizes deal for acquiring Bever, a Singapore pharma company.

Eisai files a petition with federal appeals court to require the Drug Enforcement Agency to put anti-epilepsy drug Fycompa on the controlled list of substances.

Sangamo BioSciences has agreed to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus (AAV) gene therapies.

Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company?s new biomanufacturing facility.

Reversible nanoencapsulation technology may make it possible to deliver high molecular weight drugs directly to target cancer cells, increasing efficacy and reducing side effects.

Akorn will acquire Hi-Tech Pharmacal for $640 million.