Regulatory Affairs
Presidents of the European Commission and European Council and UK Prime Minister Boris Johnson on Friday signed a withdrawal agreement that will see the UK continue to follow EU rules through the end of the year while seeking a deal for future ties with the EU.
Posted: January 24, 2020, 9:06 pm
The US Food and Drug Administration (FDA) on Friday finalized guidance to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials for treating specific hematologic malignancies.
Posted: January 24, 2020, 7:39 pm
Back in November, the US Department of Health and Human Services (HHS) took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).
Posted: January 24, 2020, 5:49 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: January 24, 2020, 5:24 pm
This article discusses employing regulatory affairs consultants and offers advice on who needs consultants and why, the “dos and don’ts” of finding, managing and maintaining consultants, how to choose the right consultant with the right background and expertise for the needed tasks and consultant service and pricing models.
Posted: January 24, 2020, 5:00 pm
Biotechnology
Adaptive Biotechnologies Corporation, a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced today the pricing of its underwritten public offering of 8,000,000 shares of its common stock by certain selling shareholders at a public offering price of $26.50 per share, before underwriting discounts and commissions.
Posted: January 24, 2020, 12:00 am
Genentech, a member of the Roche Group, announced that the Phase III IMvigor010 study evaluating Tecentriq® as an adjuvant monotherapy treatment did not meet its primary endpoint of disease-free survival compared to observation in people with muscle-invasive urothelial cancer.
Posted: January 24, 2020, 12:00 am
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, Genentech’s chief medical officer and head of Global Product Development.
Posted: January 24, 2020, 12:00 am
Pharma and life sciences companies strengthen their leadership and boards with this week's appointments.
Posted: January 24, 2020, 12:00 am
The layoffs are in departments across the company that aren’t central to its consumer testing and therapeutics business.
Posted: January 24, 2020, 12:00 am
Pharmaceuticals
As epidemiologists race to contain the outbreak of a novel #coronavirus, they’re getting backup from the explosion in genetic technologies
Posted: January 25, 2020, 12:21 am
Patient Services agreed to settle allegations of violating federal law by enabling drug makers to pay kickbacks to Medicare patients who took their medicines.
Posted: January 24, 2020, 8:51 pm
History suggests the road to a vaccine for the new pneumonia-causing virus will be long, unpredictable, and expensive.
Posted: January 24, 2020, 8:03 pm
STAT Plus: What does the latest twist in the Sarepta saga mean for the future of the FDA? We discuss
Recent documents reveal a stark divide within the FDA over its Sarepta drug approvals. We discuss.
Posted: January 24, 2020, 7:38 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: January 24, 2020, 4:18 pm
Human Resources
Romance at work isn't necessarily a bad thing, sources told HR Dive, but it can create consequences ranging from irritating to legally actionable.
Posted: January 24, 2020, 5:02 pm
The suit comes at an uncertain moment for federal LGBTQ workplace discrimination protections.
Posted: January 24, 2020, 4:44 pm
While the extent of Title VII's protections for gender identity is still unclear, experts say employers should strive to create a culture of inclusivity.
Posted: January 24, 2020, 4:18 pm
AI is driving changes in recruiting, learning — but employers must proceed with caution, report says
To truly realize the tech's potential, employers may need to think about talent differently.
Posted: January 24, 2020, 3:47 pm
But one of the biggest struggles for employers may be ensuring talent practices live up to employee expectations.
Posted: January 24, 2020, 3:41 pm