If clinical trials are successful, roluperidone (MIN-101) will be the first treatment approved to treat symptoms of schizophrenia in the United States.

The inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The new microscope gives fast, deep, and clear images for live observation over long periods and allows scientists to study a larger range of applications.

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.

Under a new co-development license agreement, Boehringer Ingelheim and Inflammasome Therapeutics aim to develop novel therapies for retinal diseases.

The project focused on accelerating the discovery and development of monoclonal antibodies and aimed to tackle the limitations in the biologics supply chain.

The new site will provide employees with more space, enhanced R&D facilities, and a fully functional sanitary products training center.

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.

A request has been made to the CHMP by the executive director of EMA to provide guidance on how to avoid the presence of nitrosamine impurities in human medicines.

Novo Nordisk has revealed the findings from an exploratory analysis of Phase IIIa clinical development program, demonstrating improved glycemic control with oral semaglutide.

Procarta Biosystems has received an award from CARB-X, potentially worth $9.2 million, for the development of antibiotic precision medicines.

The new CMO combines SK Biotek in Korea, SK Biotek in Ireland, and AMPAC Fine Chemicals in the US to form SK Pharmteco.

PSE, a supplier of advanced process modeling software and services, plans to become part of Siemens Digital Industries.

The new board will assume their positions at the 2019 ISPE Annual Meeting & Expo on Oct. 27–30, 2019 in Las Vegas, NV.

The company will supply its heparin sodium injection in prefilled syringe form.

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The merger creates a combined organization with a leading position in the eClinical market.

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

The companies have engaged in a manufacturing scale-up of LTX-03 tablets for clinical testing using LIMITx Technology.

The device can produce up to 130,000 tablets per hour and completes design of experiment and research studies with little material and multiple tooling formats.

Starting on Oct. 1, 2019, CMC Pharmaceuticals will focus on upgrading laboratory SOPs and documentation practices to comply with FDA guidelines.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.