American Pharmaceutical Review

American Pharmaceutical Review
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Pharmaceutical Grade Chemicals – And More Many companies can supply a pharmaceutical chemical, but how many have the experience, the expertise and the quality to ensure that your products always meet your quality standards, FDA regulations, and the demands of healthcare consumers? Spectrum Chemical Mfg. Corp., headquartered in New Brunswick, New...

While Puerto Rico is making progress in its effort to recover from the devastation left by the hurricanes, it remains a long process and there’s a lot of work left to do. At the FDA, we’re vigilant about helping address the challenges that remain. Power is being restored across the island and, importantly, some major medical product manufacturing...

Ferring Pharmaceuticals and Aché Laboratórios Farmacêuticos announced their joint nanotechnology center in São Paulo, Brazil. Focused exclusively on nanotechnology research and development, the center forms the first phase in a long term collaboration to optimize patient care through enhanced drug delivery systems and product solutions. The...

U.S. Stem Cell responded to the recently-announced Food and Drug Administration’s (FDA) comprehensive policy framework for the development and oversight of regenerative medicine products, including stem cell treatments. The framework is described among four FDA guidance documents that build upon its existing, risk-based regulatory approach that...

The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken today by the EU 27 Member States in the margins of the General Affairs Council. The Agency has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. “We welcome today’s decision on...

Fresenius Kabi will expand itsmanufacturing operations in Wilson County, Governor Roy Cooper announced. The expansion project will bring hundreds of new jobs and more than $100 million in investment to Wilson, where the company currently employs more than 100 people.“I’m proud that North Carolina is home to so many strong life sciences companies...

Quotient Sciences has acquired Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, U.K.. The acquisition supports the growth of Quotient’s Translational Pharmaceutics platform, following the acquisitions of SeaView Research and QS Pharma in February 2017. Pharmaterials has a track record in supporting the...

Amgen announced that the ENBREL Mini with AutoTouch is now available in the United States. The new delivery system provides an additional administration option for appropriate ENBREL patients. The AutoTouch reusable autoinjector has an ergonomic design that includes an ergonomic handle, a needle designed to stay hidden during the injection, a...

Results from two early clinical trials show that it may be possible to use human embryonic stem cells as treatment for the dry form of macular degeneration, according to presentations given today at AAO 2017, the 121st Annual Meeting of the American Academy of Ophthalmology. Stem cells injected into the eye appear to have replaced the missing cells...

Mylan announced the U.S. launch ofClofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials, a generic version of Genzyme's Clolar. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of pediatric patients 1 to 21...