Regulatory Affairs
Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety information for marketed Class II, III and IV medical devices.
Posted: June 18, 2019, 7:39 pm
Swiss notified body (NB) QS ZÜRICH AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.
Posted: June 18, 2019, 7:01 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: June 18, 2019, 5:40 pm
The lengthy preclinical and clinical development necessary to bring a biologic to market has often been cited as one of the central reasons why biologics deserve 12 years of market exclusivity, or about five years more exclusivity than their small molecule counterparts.
Posted: June 18, 2019, 3:20 pm
Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday.
Posted: June 18, 2019, 2:37 pm
Biotechnology
Public-private investment will prepare 8th-12th grade students in rural communities for careers in biomanufacturing of agriculture, medicine, food and beverage products.
Posted: June 18, 2019, 12:00 am
Stoke Therapeutics, Inc. announced the pricing of its initial public offering of 7,891,110 shares of its common stock at a price to the public of $18.00 per share.
Posted: June 18, 2019, 12:00 am
EXUMA Biotechnology, a clinical-stage biotechnology company discovering and developing CAR-T products for solid tumors and affiliate of F1 Oncology, Inc., announced the expansion of its leadership team with the appointment of Wendy Li, M.D. as Chief Medical Officer and James Samuels as Chief Financial Officer.
Posted: June 18, 2019, 12:00 am
QPS announced continuing growth in Asia, a region that is fast becoming a robust biotech and pharmaceutical research hub.
Posted: June 18, 2019, 12:00 am
Novigenix SA announced the appointment of Francois Martelet, M.D., to its Board of Directors as a non-executive director.
Posted: June 18, 2019, 12:00 am
Pharmaceuticals
Scientists have developed a proof-of-concept tool that would allow smartphones or devices like Amazon's Alexa to detect gasps people make after cardiac arrest.
Posted: June 19, 2019, 9:00 am
Compounding pharmacies — and the patients they serve — benefit from a strong regulatory framework. But it needs to be a practical one that assures that patients have access to…
Posted: June 19, 2019, 8:45 am
For more than a decade, biosimilars have flourished in Europe. That hasn't happened in the U.S. because of misinformation and poor market preparation.
Posted: June 19, 2019, 8:40 am
The potential pitfalls of applying AI in medicine were the focus of a panel at a Harvard Medical School conference Tuesday.
Posted: June 19, 2019, 8:35 am
Before liquid biopsy tests can become a reality for early cancer detection, there are issues that need to be ironed out.
Posted: June 19, 2019, 8:30 am
Human Resources
The tech giant's employee volunteers have provided more than 1,000 hours of support to the project, which serves 6 million children.
Posted: June 18, 2019, 6:22 pm
A majority of CEOs also believe a "fail fast" culture, in which "lessons from failures are learned quickly," drives innovation today, KPMG said.
Posted: June 18, 2019, 5:00 pm
The program will provide access to degrees in leadership, business management, IT, leadership, aviation management and the liberal arts.
Posted: June 18, 2019, 4:48 pm
The former employee said her firing was linked to the cost of her husband's cancer treatments, which he received at the hospital.
Posted: June 18, 2019, 3:22 pm
Transparency and commitment to hiring goals can prevent perceptions from getting in the way, speakers at a U.S. Chamber of Commerce event said.
Posted: June 18, 2019, 3:07 pm