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.

The companies will collaborate the manufacture of personalized cancer vaccines.

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 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.

The Intelligent Control Inhaler is an intuitive, fully-integrated device delivering accurate doses of medication to patients, while providing on-screen instructions for use and feedback to the patient and healthcare provider via an app.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.

Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.