KBI Biopharma's acquisition of Elion Labs expands KBI's biophysical and analytical characterization capabilities.

Carver will feature its Auto Series Plus automatic hydraulic laboratory press at Pittcon 2018.

The acquisition would boost Sanofi's position in hematology and specialty medicines.

The acquisition builds on the companies' earlier collaboration to develop T-cell-based therapeutics.

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.

The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.

Paragon Bioservices will build a new cGMP facility in Maryland and expand its existing cGMP facility at the University of Maryland's BioPark.

Clover Biopharmaceuticals will use GE's FlexFactory biomanufacturing platform with single-use bioreactors to produce innovative and biosimilar fusion protein products in China.

The FDA center released its list of planned guidance documents for the rest of the year.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.

1CryoBio’s Flexiquot technology allows for the deep-freeze storage and handling of multiple aliquots in a single tube, winning it the CPhI Pharma Award 2017 for Excellence in Pharma: Analysis, Testing, and Quality Control.

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

The NGC Fraction Collector from Bio-Rad Laboratories allows researchers to choose how to collect and when to access their fractions for analytical or preparative chromatography applications.

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.

FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.

The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.

A ceremony was held at Cambrex’s Karlskoga facility to mark the commencement of a long-term manufacturing agreement with AstraZeneca for a key intermediate.