Pharmaceutical Technology Editors

IDT Biologika will provide fill/finish services of live-vectored virus products in clinical development through licensure.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

Datwyler is channelling more than CHF 100 million into building a new plant in the US state of Delaware, which will be used to manufacture elastomer components for injectable drug-delivery systems.

BASF announced that steamcrackers are slowly being restarted at the company’s plant in Ludwigshafen.

The new patented desiccant stoppers improve the opening of tablet tubes used to contain lozenges, effervescent, and chewable tablets.

Merck is providing WHO with approximately 10 million tablets for Ivory Coast.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

Natoli Engineering is hosting a technical training course on the basics of tablet manufacturing and troubleshooting. Natoli is holding the three-day course for professionals in the pharmaceutical, tablet compression, veterinary, nutritional, confectionary, and industrial markets. The dates for the 2017 course are:

The researchers were awarded the Thomas Alva Edison Patent Award for a solventless method for coating APIs.

Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain

An explosion and fire at a BASF plant in Ludwigshafen that left two dead resulted from work on a pipeline containing ethylene and propylene product.

The company announced plans to begin shipping Inflectra to the US market in late November 2016.

The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.

The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

CordenPharma announced the completion of a new highly potent process bay for APIs at the company’s Colorado facility.

The companies will collaborate the manufacture of personalized cancer vaccines.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Recipharm launched a showcase line to demonstrate the company’s new serialization solutions.

Piramal entered into an agreement with Janssen Pharmaceuticals to acquire five of the company’s injectable products.

FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

Marken announced the opening of a new depot and logistics operations center in Argentina.

Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.