Pharmaceutical Technology Editors

Sharp acquired the pharmaceutical packaging facility in Bethlehem, PA.

Uhlmann Packaging Systems joined the OPC Foundation’s Open Serialization Communication Standard (OPEN-SCS) Working Group.

In a new study, researchers from Boston Children’s Hospital study responses to pneumococcal vaccine in infant monkeys.

The conference has partnered with Mercy Ships, a non-profit organization using hospital ships to deliver health care to developing nations.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

The recall was issued because of a defective delivery system; the units affected had possible package leakage.

MilliporeSigma’s new high-area cartridge filters and single-use capsules are suitable for feed streams with high levels of particulates.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.

Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.

Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.

EMA has developed a framework and action plan to foster relationships with the academic community.

Sartorius acquired the Swedish company that specializes in data analytics software for biopharmaceutical development and manufacturing.

Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.

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.

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.

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.

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.

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.