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Moscow Hosts IFPMA Biosimilars Conference

May 17, 2013

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

AbbVie and Alvine Will Collaborate on Celiac Disease Therapy

May 15, 2013

Program aims to develop a novel oral treatment.

FDA Issues Pharmacoepidemiologic Safety Study Guidance

May 14, 2013

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

USP Launches Initiative to Fight Counterfeit Drugs in Sub-Saharan Africa

May 13, 2013

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

Amgen Forms New Joint Venture to Commercialize Vectibix in China

May 13, 2013

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.

ATMI Offers Helium Integrity Testing System

May 10, 2013

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

EMA Revises Draft Guideline on Biosimilars

May 8, 2013

EMA clarifies biosimilars guidelines.

FDA Accepts BLA for Merck's Allergy Immunotherapy Tablet

May 8, 2013

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

Actemra Receives FDA Approval for Polyarticular Juvenile Idiopathic Arthritis

May 1, 2013

Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older.

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