News

Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

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FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.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

AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

Siegfried is proceeding with its expansion in China and Switzerland.

Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.

Amgen acquires Onyx Pharmaceuticals for $125 per share in cash.

Vical's restructuring will leave the company with approximately 74 employees.

Top four graduate students to be hosted at GE Healthcare Life Science's Uppsala site.

Andrew Derodra will join Skyepharma in the fourth quarter of 2013.