News

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.

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

States oppose the company’s plans for a Chapter 11 settlement, which would restructure the company as a trust and cap funding to plaintiffs, Reuters and other news outlets report.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

Bora Pharmaceuticals has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.

ACG Group has announced the winners of its ‘Art in a Capsule’ competition, where entrants were challenged to create miniature works of art that could fit inside a capsule.

BioCity has invested in Maxwellia, a company based at Alderley Park in the United Kingdom that is driving industry movement towards self-care therapeutics.

BIA has signed a memorandum of understanding with AstraZeneca and the Wuxi International Life-science Innovation Campus (I-Campus) to boost access for UK SMEs in China.

EC has granted marketing authorization approval to Roche for Tecentriq (atezolizumab), in combination with chemotherapy, as a first-line treatment for patients with extensive-stage small cell lung cancer.

The ABPI and BMA have issued responses to the publication of a government report into the scale and distribution of prescribed medicines in England.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

The supply agreement comes after an eight-year collaboration between the companies.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.