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FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

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.

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

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.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

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

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

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.