Pricing of a lifesaving allergy treatment raises concerns.

The new facility is solely dedicated to offer extractables and leachables (E&L) testing services to the pharmaceutical and related industries.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.

Results from a small Phase Ib trial with Biogen’s aducanumab showed the drugs potential as an investigational treatment for patients with Alzheimer’s disease (AD). Researchers from the University of Zurich evaluated the efficacy of aducanumab in 165 patients with early-stage AD. At the conclusion of 54 weeks, the researchers reported seeing a dose-dependent reduction of amyloid-beta in patient’s brains compared to a placebo. Exploratory results indicate the drug may also slow clinical decline.

GE and Sealed Air extend their long-term collaboration to develop single-use films purposefully constructed for bioprocessing applications.

SpacePharma will give US researchers access to microgravity solutions to advance R&D projects.

The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.

The AIM-9000 infrared microscope contains automated analysis functions and a wide-field camera option.

ISPE announced the results of its 2016–2017 International Board of Directors election.

The merger of Avantor Performance Materials and Nusil Technology positions the company for growth in bioprocessing.

The company announced that it will be expanding its portfolio of single-use vessels for fermentation.

Organization plans networking event at CPhI Worldwide to serve expanding global membership.

The Empyrean Nano edition offers a combination of advanced X-ray scattering techniques.

API and drug product manufacturer changes name to align with parent company.

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

The agreement comprises technology transfer and commercial manufacturing of Tillotts’ gastroenterology products.

Sandoz won FDA approval for its biosimilar version of Enbrel.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Researchers at the Massachusetts Eye and Ear Infirmary developed a potential drug delivery method using a contact lens to deliver glaucoma medication.

The company is voluntarily recalling one lot of product due to a potential packaging mistake.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

FDA issued a warning letter to College Pharmacy for multiple violations.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.