Regulatory Affairs
In the event of a no-deal Brexit, the National Institute for Biological Standards and Control (NIBSC) will be a stand-alone National Control Laboratory, and the UK will require national certification by NIBSC before batches of biological medicines can be placed onto the UK market, according to guidance released Tuesday.
Posted: February 19, 2019, 9:13 pm
The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.
Posted: February 19, 2019, 9:03 pm
Ocular Therapeutix drew a US Food and Drug Administration (FDA) warning letter for failing to comply with post-approval study requirements (PAS) set as part of its ReSure Sealant’s conditional approval.
Posted: February 19, 2019, 7:55 pm
The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized on Tuesday the classification of the auto titration device for oral appliances into class II with special controls.
Posted: February 19, 2019, 6:59 pm
Research published in JAMA on Tuesday details how a US Food and Drug Administration (FDA) class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients.
Posted: February 19, 2019, 6:58 pm
Biotechnology
Global healthcare spending is expected to increase dramatically to more than $10 trillion by 2022, driven primarily by an increase in spending on data that will increase value and create a sustainable culture.
Posted: February 20, 2019, 12:00 am
Proxy-CRISPR technology provides solution to improve genome editing and advance new possibilities for research
Posted: February 19, 2019, 12:00 am
On Monday, N.C. Gov. Roy Cooper announced the expansion to the company’s Durham facility that was first announced in May 2018. It's expected to provide up to 200 additional jobs.
Posted: February 19, 2019, 12:00 am
AP-CD/LD met primary endpoint of reducing plasma levodopa variability compared to standard oral CD/LD with statistical significance
Posted: February 19, 2019, 12:00 am
Intercept Pharma plans to seek regulatory approval in the U.S. and Europe in the second half of this year.
Posted: February 19, 2019, 12:00 am
Pharmaceuticals
The biopharma industry is often painted as a villain. But from my perspective as someone with a rare disease, that label is scarily without nuance.
Posted: February 20, 2019, 9:45 am
Dr. Taha Kass-Hout, a senior leader of artificial intelligence at #Amazon, emphasized the need to back up the hype surrounding #AI with validated results.
Posted: February 20, 2019, 9:40 am
The psychiatry field is buzzing with anticipation — and hesitation — about esketamine for depression
Many experts have lauded esketamine as an important option for patients with depression, but others aren’t convinced there’s enough data to show it is effective.
Posted: February 20, 2019, 9:35 am
There’s a critical national shortage of a #cancer drug that has been used for decades and that is a remarkably effective medicine.
Posted: February 20, 2019, 9:30 am
Federal prosecutors are more aggressively pursuing drug makers for wayward programs that provide patients with free medications, copay assistance, or other help.
Posted: February 19, 2019, 7:25 pm
Human Resources
As employers scramble to train staffers on cybersecurity threats, lack of available talent is exacerbating the problem.
Posted: February 19, 2019, 8:06 pm
VR-based training may grow more popular if the technology continues to prove its usefulness in the workplace.
Posted: February 19, 2019, 7:46 pm
To ensure programs are successful, employers have to bridge the divide between their needs and the needs of employees.
Posted: February 19, 2019, 7:33 pm
The Dough & Degrees program will cover tuition costs for undergraduate and graduate degrees through Purdue Global’s online platform.
Posted: February 19, 2019, 6:44 pm
Some have alleged the closure is retaliation for workers' highly publicized pregnancy discrimination allegations.
Posted: February 19, 2019, 4:33 pm