BioPharm International Editors

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

Japanese drugmaker Otsuka announced plans to buy CNS-specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the prenatal blood test, Harmony.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

Merck announced an agreement with NewLink Genetics to acquire exclusive rights to its experimental Ebola vaccine, rVSV-EBOV, for $50 million.

The more than $200 million project will increase production capacity at the facility to support AstraZeneca?s maturing pipeline.

GSK and Novartis announced a meeting on Dec. 18, 2014 to discuss the $20 billion asset swap between the two companies.

Ulf Wiinberg has resigned as Lundbeck's CEO over unapproved acceptance of shares in a biotech company.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

USP and ChP jointly host two-day meeting to strengthen cooperation.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

The $200-million project will expand Amgen's single-use/disposable manufacturing capabilities.

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

ValiRx entered into a collaboration agreement with the Deutsches Krebsforschungzentrum cancer research center.

The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.

The Alios Biopharma acquisition strengthens J&J's infectious disease pipeline.

USP releases compendium of quality standards for compounded medicines.

GE Healthcare and Takeda Pharmaceutical Company announced an alliance to develop therapeutic drugs in the field of hepatic fibrosis to treat various liver diseases.

The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.