News

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.

The company opened its new global headquarters in Japan.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.

The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.

Catalent’s acquisition of Juniper Pharmaceuticals further expands its early development capabilities.

The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

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.