The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

The company has invested GBP9 million (approximately $11.6 million) to fund a new multiple-phase pharmaceutical manufacturing, packaging, and distribution facility in Wales, United Kingdom.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

New study shows China biopharma companies face staffing shortages.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

Philadelphia plays host to CPhI North America on May 16-18, 2017.

The company received priority review for its investigational CAR-T therapy to treat leukemia.

The newly installed Harro Hӧfliger encapsulation unit expands Capsugel’s clinical- and commercial-scale capacity for dry powder inhalation projects.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.

Under the agreement, Laurus Synthesis will provide chemistry development services and manufacturing in support of an upcoming clinical trial evaluating EPX-100 in adolescents suffering from Dravet syndrome.

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.

The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.

FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.

The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.

Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.

The company has secured an additional facility in Hampton, Middlesex, as part of a project to expand its UK-based operations by 15% in 2017.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

Aptar Pharma’s ophthalmic squeeze dispenser is the first and only FDA-approved delivery system for prescription eye-treatment formulations without any preservatives.

FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.

The company said it plans to expand diabetes manufacturing facilities in the United States.

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.