The agency has revised its good pharmacovigilance practices guide on risk management systems.

Company representatives said a bulk of the increase was due to strong sales of its bioprocessing products.

Cirrus Pharmaceuticals will launch services for manufacturing cGMP materials for early-phase clinical trials at its Raleigh-Durham, NC facility.

The collaboration is part of Innovate UK’s competition for the development of regenerative medicines.

Under the agreement, Caribou has granted IDT worldwide rights to commercialize CRISPR-Cas9 reagents under Caribou’s intellectual property.

Robert Califf has been confirmed by the US Senate as FDA commissioner.

ICIG’s CordenPharma Group expands fermentation-based production technology with acquisition of Sandoz Site.

Curida entered into a partnership with René Bommer, PhD, founder and owner of pharmAccel Consulting.

The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.

Patheon will assist in the development of INTAC, a technology designed to reduce the abuse of controlled substances.

Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.

AAIPharma/Cambridge Major Labs plans to invest $10.7 million to relocate the company’s analytical testing facility to the Cortex Innovation Center in Missouri.

PharmSource report addresses how the opportunity for antibody drug conjugates measures up to the bio/pharma industry’s expectations.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

The directorate is looking for experts to join the European Pharmacopoeia network.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

Recipharm plans to invest €40 million in the project as a result of EMA decision to make serialization of licensed drug products a legal requirement by 2019.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

Unchained Labs acquires Freeslate, marking the company’s fourth acquisition in the past 12 months.

Smart glasses enhance remote troubleshooting and process management for pharmaceutical manufacturing.

Effective design of the tablet core and the coating process can help prevent film coating problems.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

This marks Vetter’s fourth internationally recognized award for its syringe closure system, Vetter-Ject.

The collaboration will allow the companies to develop and manufacture novel inhaled therapeutics.

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.