BioPharm International Editors

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

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 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.

A new target for the treatment of multiple myeloma using CAR-T technology was discovered by researchers at Osaka University.

An antibody-based Zika virus therapeutic that protected monkeys from infection might be safe enough for administration to pregnant women.

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

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 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.

Pharma Team Up has launched Poseidon, an integrated ocean freight program, to address the disconnect between pharma companies and their logistics providers.

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

AptarGroup’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

The company is voluntarily recalling product because of glass particles found in vials.

The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.

The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

The companies have entered an agreement involving assay development and the manufacturing of kits supporting biomarker research programs.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.