
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

Sciex’s latest additions to its biopharma portfolio helps to optimize workflow for better analytics in the lab.

The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).

Hamilton Robotics and Waters Corporation have partnered to develop StarWorks, automated, end-to-end workstations for biopharmaceutical sample preparation.

Thermo Fisher Scientific’s mass spectrometer combines mass-analyzer technology with an intelligent data acquisition strategy.

The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.

Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

The companies will partner to develop T-cell therapies for cancer.

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

Vac-U-Max received “atmosphères explosibles” or equipment for potentially explosive atmospheres (ATEX) approval for three product ranges of compressed-air-powered vacuums.

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The approval is intended to increase patient access to treatment for opioid addiction.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.