News

FDA’S CDER and ORA have entered into a concept of operations agreement to integrate facility evaluations and inspections for human drugs.

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

The KBF 1020 constant climate chamber from Binder offers storage for large quantities of test specimens or large samples.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

The private equity funding will enable the startup biotech firm to expand product development as well as sales and marketing capabilities.

Watson-Marlow Fluid Technology Group added platinum-cured silicone gaskets and platinum-cured silicone braided hoses for fluid path validation to its BioPure range.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Sartorius Stedim Biotech presents a new system for laboratories needing low volumes of ultrapure water.

Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

The International Society for Pharmaceutical Engineering (ISPE) announced its Europe Pharma 4.0 Conference, taking place November 23 – 24, 2017 in Verona, Italy.

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.

The agency published guidance on identifying trading partners under DSCSA.

FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.

GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.

The 2017 Chem Show announced the focus of the event’s latest installment taking place from October 31 - November 02, 2017 at the Javits Center in New York City.

The $12-million acquisition will strengthen Cancer Genetics Inc.’s (CGI) capabilities in drug discovery, drug development, and early phase clinical trial testing in the field of oncology.

A research collaboration joins Aslan with an academic research institute for studying small-molecule cancer drug candidates.

The US Patent and Trademark Office issued three new patents that extend protection for Alexion’s rare-disease drug, Soliris, for an additional 10 years.

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

The MDL15 combustible dust air-vac from Vac-U-Max is part of the company’s industrial vacuum cleaning product range for combustible dusts and offers high-volume cleanup of powders and combustible dusts.

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

Lonza announced an endothelial cell application center, which expands Lonza’s support for researchers.

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.