News

Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines.

Program aims to develop a novel oral treatment.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by FDA for the treatment of metastatic colorectal cancer.

Evaluation system for single-use bags and assemblies is now available for onsite testing.

EMA clarifies biosimilars guidelines.

The FDA has accepted for review Merck's Biologics License Application for its investigational ragweed pollen sublingual allergy immunotherapy tablet.

New line in Swiss facility produces ready-to-fill syringes.

Pharmaco-Kinesis Corporation (PKC) announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego's department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation.

New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes.

Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus.

A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients.

BioPharm International has joined with Dun & Bradstreet Credibility Corp. to launch the Pharmaceutical Technology and BioPharm International Marketplace.

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation.

FDA issues draft guidance to minimize medication errors.

AstraZeneca and BIND Therapeutics have formed a strategic collaboration to develop and commercialise BIND's Accurin, a targeted and programmable cancer nanomedicine, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca.

Third compounding pharmacy recalls products due to FDA inspection.

Unique technology expands Entegris? fluid-sensing and control offering.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

New manufacturing route improves availability of ingredient for malaria treatment.

Big Biotech companies are demonstrating they are better positioned than their pharmaceutical industry counterparts to meet changing demands.

The facility in Hangzhou will package Merck medicines for China and the Asia-Pacific region.

Amgen Inc. has agreed to pay the United States $24.9 million to settle allegations that it violated the False Claims Act.

$13.6 billion deal strengthens Thermo?s leading role.

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

New facility for Bio-Manguinhos will use plant-based protein expression technology.

The process-driven system reduces total cost of ownership.