Pharmaceutical Technology Editors

The European Medicines Agency has recommended Luxturna (voretigene neparvovec) as the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

The agreement now includes 15 European Union (EU) member states.

The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.

The company announced it is creating a new Primary Care global business unit and a China & Emerging Markets unit.

The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.

The company will be presenting at CPhI Worldwide on Oct. 11, 2018.

The company will showcase its line of connected devices at and its new PureHale portable drug delivery device designed for upper respiratory care.

Omya will showcase Omyapharm 500-OG (calcium carbonate and tribasic calcium phosphate) at CPhI Worldwide in Madrid, Spain, on Oct. 9–11, 2018.

The company will showcase its gelatins for advanced pharmaceutical and biomedical applications at CPhI Worldwide on Oct. 9–11, 2018 in Madrid, Spain.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The companies have partnered to launch Conjugated Polymer Nanoparticle (CPN) products for use in molecular imaging and R&D applications.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

PCI Pharma Services and CSP Technologies will partner on protective packaging solutions for clinical trials and stability testing.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year project for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Evonik completed a EUR 36 million expansion of its contract-manufacturing capabilities for API and advanced intermediates in the United States and Germany.

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

Guenter Nadler, director of Business Development at Aptar Pharma, will present an insight briefing on new drug-delivery trends in treating upper and lower respiratory tract issues on Wednesday, Oct. 9, 2018 at CPhI Worldwide.

On Wednesday, Oct. 9, 2018, Dr. Caroline Bauer will discuss selecting technologies that enable the progression of compounds that require bioavailability enhancement to achieve target absorption at CPhI Worldwide.

Researchers from Ruhr-Universität Bochum in Germany and the National Institutes of Health modified the protein Nurr1 to enter cells from the outside, possibly enabling the protein to become a drug development candidate for illnesses such as Parkinson’s disease.

Researchers at Vanderbilt University Medical Center have isolated the first human monoclonal antibodies (mAbs) that can neutralize norovirus, a virus that causes acute gastrointestinal (GI) illness.

The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform.

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

At CPhI World-Wide 2018, Bosch will display its Xelum R&D for laboratory-scale continuous OSD production and its new data-mining service for equipment and process troubleshooting.

August Faller will demonstrate boxes for expanded communication space, smart packaging, and tamper-evident labels.

The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.