News

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

Acquisition will strengthen AstraZeneca?s respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease.

Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

Modular containment room at Belfast facility allows studies of biologics and vaccines.

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The agreement is worth up to $552 million, depending on meeting set milestones.

ISTA will pay $33.5 million to resolve criminal liability and false claims allegations.

FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.

Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.

GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.

Competence in process safety is important for preventing accidents.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

Project will optimize expansion and harvest of human cells in bioreactors.

New design meets new process requirements.

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.