FDA blasts another US drugmaker for faulty quality controls on now-recalled thyroid meds

October 21, 2020

Category: FDA, Regulations

The COVID-19 pandemic has put a damper on the FDA’s on-site inspections in 2020, but that doesn’t mean the agency isn’t making the rounds and putting drugmakers on notice. A second U.S. company making prescription thyroid meds is on the […]

Coronavirus clinical trials are pausing over safety concerns – here’s what that means

October 15, 2020


Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants. J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate […]

Rentschler Contributes to COVID-19 mRNA Vaccine Manufacture

October 9, 2020

Rentschler Biopharma agreed to serve as CDMO partner for BioNTech whereby Rentschler Biopharma will be responsible for key aspects of cGMP drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech, and […]

Manufacturing, Research and Development

CNS Pharmaceuticals Completes U.S. Manufacturing of Berubicin

October 20, 2020

Via: Contract Pharma

CNS Pharmaceuticals Inc.’s U.S. manufacturer, Pharmaceutics International Inc., has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. “Completing the manufacturing […]

FDA, Regulations

FDA Approves New Container System for Peritoneal Dialysis Solutions

October 19, 2020

Via: BioSpace

Fresenius Medical Care North America’s (FMCNA) Renal Therapies Group announced today that DELFLEX peritoneal dialysis solutions in Biofine, an innovative bag material, has been approved by the U.S. Food and Drug Administration (FDA). The milestone marks another important step in […]

Cell and Gene Therapy, Industry

Deep Learning Model Developed to Identify Appropriate Lung Cancer Therapy

October 19, 2020

Via: Genetic Engineering and Biotechnology News

Choosing the right therapy for a non-small cell lung cancer (NSCLC) patient may be difficult, as biomarkers can change during therapy rendering that treatment ineffective. Now researchers from the Moffitt Cancer Center report they are developing a noninvasive, method to […]

Manufacturing, Research and Development

Manufacturing a Personalized Cellular Universe: 3D Bioprinting in the Biotech Industry

October 16, 2020

Via: BioSpace

Tissues in the body work as a complex team of interconnected cells. For instance, the heart is comprised of contractile cardiomyocytes, along with a vast array of endothelial cells, immune cells and fibroblasts. Similarly, the liver includes hepatocytes, immune cells, […]

FDA, Regulations

FDA Warns of Dangers of Common Painkillers During Pregnancy

October 16, 2020


If you’re pregnant and you think popping nonsteroidal anti-inflammatory drugs (NSAIDs) for your aches and pains is safe, think again. The U.S. Food and Drug Administration warned on Thursday that taking these widely used painkillers — which include Advil, Motrin, […]