A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain

An explosion and fire at a BASF plant in Ludwigshafen that left two dead resulted from work on a pipeline containing ethylene and propylene product.

The company announced plans to begin shipping Inflectra to the US market in late November 2016.

The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.

The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

CordenPharma announced the completion of a new highly potent process bay for APIs at the company’s Colorado facility.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.

A new study proposes a new way to potentially treat congenital diseases in utero.

A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica’s pain patent.

Piramal entered into an agreement with Janssen Pharmaceuticals to acquire five of the company’s injectable products.

FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

Marken announced the opening of a new depot and logistics operations center in Argentina.

Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.

The company revealed its new Always Solving corporate identity following its eventual separation from Valvoline.

The companies entered into a collaboration and license agreement for Crescendo’s Humabody-based therapeutics.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

Mylan reached a $485-million settlement with the Department of Justice over questioned raised about the Medicaid rebate classification of EpiPen.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

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