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

The mAb is the first approved treatment that targets the progressive form of the disease.

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 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.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

Fisher BioServices will expand its CryoHub solution by co-locating it with the Cell and Gene Therapy Catapult manufacturing center for seamless supply chain management and to accelerate cell and gene therapy production.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The company has invested in a new pharmaceutical chemistry and microbiology facility in Scotland.

The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

Aptar Pharma’s newly-expanded site will be used to complete premium injectable elastomeric component manufacturing.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.