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During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity component needs.

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.

The company celebrated 65-years of providing industrial vacuum cleaning systems to the market.

The new company name, Viatris, derives from Latin and represents the company’s main goals.

Norwegian clinical-stage immunoncology company, Lytix Biopharma, has entered into a clinical collaboration with US-based Iovance Biotherapeutics.

A clinical-stage company that was spun out of the VUB university in Belgium, eTheRNA immunotherapies, has revealed it will be participating in an EU research project aimed at developing off-the-shelf mRNA nanomedicines.

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.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

Oncologist Stephen Hahn has been nominated for the top post, following the appointment of Brett Giroir as acting commissioner.

Scientists from the University of Texas Medical Branch in Galveston and Profectus BioSciences of New York have developed the candidate quadrivalent VesiculoVax vaccine, an investigational vaccine that protected monkeys against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa.

In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.