News

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.

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

The 2018 Short Course program at Pittcon, taking place Feb. 24–Mar. 1, will feature 23 new short courses geared towards laboratory professionals.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

The company completed its oral solid dose production facility in Suzhou, China.

A Takeda and Denali collaboration includes three named programs for treating Alzheimer’s disease and other neurodegenerative diseases, using Denali’s antibody transport vehicle (ATV) technology to enhance blood-brain barrier penetration.

The company will use funding from the Bill & Melinda Gates Foundation to develop a new production method for artemisinin, a therapeutic used to treat malaria.

The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.

Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.

The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

The Tamper Evident Labeller from LSS Labelling Systems Scandinavia is compliant with the European Falsified Medicines Directive.