News

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.

The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.

Bora announced the appointment of Samuel Ricchezza as president of its North American operations.

Lonza and Cryoport have partnered up to strengthen Lonza’s ‘vein-to-vein’ delivery network by removing supply chain hurdles faced by developers of personalized therapeutics.

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.

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.

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.

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.

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

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.

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.

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 new center will handle the delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.

The companies will acquire Orflo’s two flagship products, the Moxi Z and the Moxi Go.