If Prescribed Opioids for Pain, Ask Lots of Questions: FDA

May 21, 2020

Category: FDA, Regulations

If your doctor prescribes opioid painkillers such as hydrocodone, oxycodone, codeine or morphine for you, there are a number of questions you should ask, the U.S. Food and Drug Administration advises. Opioids can be used to treat certain kinds of […]

Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19

May 15, 2020

Category: FDA, News, Regulations

Hologic, Inc. (Nasdaq: HOLX) announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Aptima SARS-CoV-2 assay to detect the novel coronavirus. The newly authorized test runs on Hologic’s fully […]

Univercells Launches New Bioprocess Subsidiary

May 7, 2020

Univercells launched a new bioprocess subsidiary—Univercells Technologies—which will focus on the commercialization of the product portfolio and will explore new technology developments to expand its position in the cell and gene therapy market, according to Mathias Garny, general manager. “With […]

FDA, Regulations

FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

May 21, 2020


Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved Kynmobi (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). OFF episodes are the […]

Clinical Trials, Industry, Research and Development, Vaccines

Expediting COVID-19 Research

May 20, 2020

Via: Genetic Engineering and Biotechnology News

The world is waiting for vaccines and treatments to mitigate the spread and severity of the coronavirus COVID-19 pandemic. The Jackson Laboratory (JAX) is working to ensure that the worldwide research community has access to a mouse model that can […]

Industry, News, Vaccines

Improving the Pneumococcus Vaccine

May 19, 2020

Via: Genetic Engineering and Biotechnology News

Vaccines that protect people from infection by Streptococcus pneumoniae, which kills up to one million children ever year worldwide, train the immune system to recognize the pathogen’s thick sugar capsule. Pneumococcus capsules are not only the active ingredient in vaccines; […]

FDA, Regulations

FDA Grants Genentech’s Checkpoint Inhibitor Tecentriq Another NSCLC Approval

May 19, 2020

Via: BioSpace

Genentech, a Roche company, announced that the U.S. Food and Drug Administration (FDA) had approved its checkpoint inhibitor Tecentriq (atezolizumab) for first-line treatment for metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. An accompanying FDA-approved diagnostic test is […]

Biotech, Industry

Trends in Bioprocess 4.0 and their Impact on Biomanufacturing

May 18, 2020

Via: Genetic Engineering and Biotechnology News

The biomanufacturing industry is currently undergoing a revolution in how it produces biopharmaceutical products. The driving force behind this paradigm shift is known as Bioprocess 4.0 or Industry 4.0. The approach focuses on how to apply data, predictive modeling, analytics, […]