Pharmaceutical Technology Editors

The new biotech company, Mereo, is based in the United Kingdom, and kicks off with three mid-stage assets from Novartis.

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

The purchase will strengthen Hikma’s position in the US generic drug market.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

Moses Lake Professional Pharmacy issues recall due to lack of sterility assurance.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

This move is expected to stimulate the exploration of many more medicines for use in children.

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity.

MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

World Courier receives pharmaceutical storage and transportation accreditation in the United Kingdom.

Katsuaki Kaito has been named president of Shimadzu Scientific Instruments.

CSafe and AES will support controlled-temperature shipping through the Basel, Switzerland airport from their new service center.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

FDA releases a report that analyses why some diseases are lacking treatment options.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

Sanofi's new business-unit structure focuses on growth drivers.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.