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Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.
July 27, 2016
FDA and industry seek speedy Congressional approval of new user fee plan.
The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.The recent resurgence of yellow fever incidences over the past six months has prompted health officials to ramp up the fight against the virus. Like the Zika virus, yellow fever is transmitted primarily through the bite of infected female Aedes aegypti mosquitoes.
The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.
July 26, 2016
The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.
July 25, 2016
The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.
July 20, 2016
Gamma-stable fluoropolymers are an alternative material for single-use bags and assemblies in biopharmaceutical manufacturing.
July 19, 2016
The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.
The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
July 18, 2016
The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.
