Regulatory Affairs
With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.
Posted: October 23, 2020, 10:19 pm
The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.
Posted: October 23, 2020, 9:31 pm
In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling.
Posted: October 23, 2020, 8:40 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: October 23, 2020, 8:10 pm
This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differerences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.
Posted: October 23, 2020, 3:00 pm
Biotechnology
Kezar Life Sciences, Inc., a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designations for KZR-616 for the treatment of polymyositis and dermatomyositis.
Posted: October 23, 2020, 12:00 am
In the meeting, both the FDA and the U.S. Centers for Disease Control and Prevention presented details about COVID-19 and the requirements for a vaccine.
Posted: October 23, 2020, 12:00 am
The pharmaceutical supply chain is being pushed to its limit as it prepares to deliver COVID-19 vaccines and therapeutics to the entire world as soon as possible, while continuing to produce and deliver all the usual medications and products.
Posted: October 23, 2020, 12:00 am
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
Posted: October 23, 2020, 12:00 am
Foghorn Therapeutics hits the Nasdaq offering 7.5 million shares at $16 apiece.
Posted: October 23, 2020, 12:00 am
Pharmaceuticals
After months of delay, Health Canada has released a final version of new regulations that are designed to cut prescription drug spending by the Canadian government.
Posted: October 23, 2020, 9:09 pm
STAT convened several leaders across the health tech industry for a virtual roundtable discussion on digital health technologies.
Posted: October 23, 2020, 8:26 pm
Two major studies of vaccines against Covid-19, both paused because of potential safety concerns, are set to restart, the companies running them said Friday.
Posted: October 23, 2020, 8:21 pm
The biotech company is working on a system to regulate genes to treat cancer.
Posted: October 23, 2020, 5:39 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: October 23, 2020, 4:26 pm
Human Resources
A September executive order prohibits contractors from delivering diversity training that includes "race or sex stereotyping or scapegoating."
Posted: October 23, 2020, 4:33 pm
HR leaders can focus on trust and team cohesion, according to the firm's report.
Posted: October 23, 2020, 2:19 pm
The NRF Foundation's new credentials will also provide enhanced training on safety measures as the COVID-19 pandemic continues.
Posted: October 23, 2020, 2:16 pm
The in-person debate began with questions regarding COVID-19 strategies and eventually touched on "Bidencare" and racism.
Posted: October 23, 2020, 1:56 pm
As employers formulate answers to the nationwide call for racial equality, many have boosted their diversity, equity and inclusion initiatives.
Posted: October 22, 2020, 3:21 pm