Pharmaceutical Technology Editors

The company's lead candidate, MGB-BP-3, has shown promising results against a broad range of multi-resistant Gram-positive strains.

Swedish CDMO, Recipharm AB, has entered into a long-term collaboration with Flamel Technologies SA, a drug-delivery company based in France. Under the terms of the agreement, Recipharm will acquire Flamel?s development and manufacturing facility located in Pessac, France, for EUR10.6 million plus the value of the inventory.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

The Singapore API facility will be operational by 2016.

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.

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

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

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

GSK Australia's Boronia site will install next-generation blow-fill-seal machinery for aseptic filling.

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

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

Shire will establish its US operational headquarters in Massachusetts and relocate staff from Pennsylvania.

CDMO Vetter has opened a new representative office in Singapore in response to growing market demand in Asia.

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

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FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

In response to the Ebola outbreak in West Africa, Nitritex has donated seven pallets of personal protection equipment (PPE), including disposable coveralls, aprons, and more than 200,000 gloves to protect the healthcare workers helping to save lives during this crisis.

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.

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

Catalent has acquired Micron Technologies, a provider of particle size engineering technologies.

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

Celerion has expanded its laboratory capabilities in response to increasing demand for cell-based assays.

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

AVEO enters into a research and exclusive option agreement with Ophthotech for tivozanib (AV-951) for the treatment of ocular diseases

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

Essentra has signed an agreement to acquire Clondalkin's Specialist Packaging Division for a cash consideration of approximately $455 million.