Pharmaceutical Technology Editors

The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

The company aims to add the additional analytical services in the European Union throughout 2018.

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

The agreement follows the recent opening of WuXi STA's oligonucleotide R&D labs in China and the US.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.

A new suite for the encapsulation of highly potent drugs will be added.

FDA and CDC are investigating a multi-state Salmonella outbreak that appears to be caused by kratom, a plant used as an opioid substitute.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

The company has entered into an agreement with an undisclosed partner to support the development and manufacture of a new biomanufacturing cell line.

Colorcon's Opadry EZ provides superior slip and significantly reduces the probability of the tablet sticking to the throat or esophagus.

The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

Fluarix Tetra has been approved for use in children aged six months and above.

The companies will work together on developing regenerative medicine therapies for heart failure.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.

The company is voluntarily recalling one lot of Acyclovir Tablet due to packaging that may contain a different product.

Honeywell offers an augmented/virtual reality approach to train the industrial workforce.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.