Regulatory Affairs
Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday.
Posted: April 19, 2019, 8:19 pm
In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.
Posted: April 19, 2019, 7:44 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: April 19, 2019, 6:10 pm
A new literature review of studies of direct-to-consumer (DTC) prescription drug advertising identifies potential positives and negatives for DTC advertising on the patient-prescriber relationship and highlights gaps in the current medical literature on the topic.
Posted: April 18, 2019, 9:12 pm
As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices.
Posted: April 18, 2019, 8:12 pm
Biotechnology
Possibly in response to a trend for Medicare-for-All initiatives, healthcare stocks plunged this week. This largely affected companies like UnitedHealth, which fell 3.2%, Anthem, dropping by 6.8%, and Cigna Corp., sliding 5.1%.
Posted: April 19, 2019, 12:00 am
Biotech, pharma and life science companies make appointments to leadership roles, with additions at Cerevance, Obsidian, KSQ, Lygos, and more.
Posted: April 19, 2019, 12:00 am
Akorn secured approval for a post-operative eye drop, as well as a generic over-the-counter version of GSK's Flonase.
Posted: April 19, 2019, 12:00 am
There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.
Posted: April 19, 2019, 12:00 am
Here’s a look at six San Francisco Bay Area life science companies that have hit a variety of “best of” lists recently, in no particular order.
Posted: April 19, 2019, 12:00 am
Pharmaceuticals
They were supposed to be novel pain treatment and future blockbusters. Instead it appears that hopes for a class of medicines called NGF inhibitors are increasingly dim.
Posted: April 19, 2019, 5:00 pm
Three months ago, this flu season was shaping up to be short and mild in the U.S. But a surprising second viral wave has made it the longest in 10…
Posted: April 19, 2019, 3:41 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: April 19, 2019, 2:09 pm
A lower dose of non-opioid painkiller developed by Pfizer and Eli Lilly failed to meet main goals in a late-stage study in osteoarthritis patients.
Posted: April 19, 2019, 1:19 pm
Michael Gilman's company, Arrakis, is going after RNA, the messenger-like molecules that turn genetic instructions into proteins.
Posted: April 19, 2019, 8:40 am
Human Resources
Employers "can't excuse the shortcomings of younger workers while bringing down the hammer on older workers," the court said.
Posted: April 18, 2019, 3:00 pm
The haste could be due to emotional discomfort; respondents in a previous survey reported that signing up for benefits resulted in stress and anxiety.
Posted: April 18, 2019, 2:58 pm
Employer maintenance of online brand reputation may be a factor driving the trend, new survey results show.
Posted: April 18, 2019, 2:48 pm
Sponsorship and mentoring are key steps on the path to the C-suite for many women in leadership roles.
Posted: April 18, 2019, 2:28 pm
These solutions come with several benefits, but tend to make communication and implementation a problem for employers.
Posted: April 18, 2019, 2:00 pm