Pharmaceutical Technology Editors

Beckman Coulter Life Sciences and IncellDx have announced a collaboration aimed at creating awareness for the oncology assays on the cytometry platform for European customers.

GE Healthcare Life Sciences has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vector-based therapies, and other novel modalities.

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

According to the first annual resport into clinical trials by the Association of the British Pharmaceutical Industry, the United Kingdom is leading the rest of Europe in early-stage clinical research into new medicines and vaccines.

The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.

Countries and partners have announced commitments to vaccinate 450 million children against polio each year and overcome barriers to reaching all children.

Xcelerate Development Services are complete solution services focused on de-risking development and ensuring speed-to-market.

The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

Through a partnership with the Sobti family, the CDMO will expand is injectable dosage form capabilities.

The new service will assist pharmaceutical companies with quality control and analytical requirements.

Catalent has named Mike Grippo as the new senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer.

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

Hovione Technology worked with Harro Höfliger on powder filling of blisters for the reusable Papillon DPI.

The companies will work to discover and develop therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC RNAi platform technology.

Alkermes plans to advance its investigational new drug-enabling capabilities for lead preclinical assets in the Rodin development candidate portfolio.

The drug will be used to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

If successful, the acquisition will boost Recipharm’s global position in the contract development and manufacturing organization (CDMO) market.

The chapter is open for comment until Nov. 30, 2019.

Through the agreement, Roche will gain full rights to the company’s portfolio of molecules for fibrotic diseases, most notably PRM-151, Promedior’s lead product candidate.

FDA issued a warning letter to the company for obtaining over-the-counter drugs made by foreign manufacturers that violated federal law.

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

With the gene-editing technology, Evotec will have the ability to accelerate research and enable the testing and development of new drugs.

The recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.

Bayer and Dewpoint Therapeutics have announced an option, research, and license agreement aimed at developing novel treatments for cardiovascular and gynecological diseases.

Phillips-Medisize, a Molex company, revealed that it is opening a new Global Innovation and Development (GID) office in Copenhagen, Denmark, to support its plans for growth.

Forming part of its ambition to contribute to the fight against AMR, Recipharm has announced that it is joining the AMR Industry Alliance, which is one of the largest coalitions set up to provide sustainable solutions to the growing problem of AMR.

A simulation-based drug discovery company, Turbine, has announced the closing of an institutional funding round worth EUR 3 million (US $3.3 million), which will be used to redesign the oncology drug discovery process.