Pharmaceutical Technology Editors

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.

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

NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.

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.

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.

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

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

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.