Regulatory Affairs
A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins.
Posted: August 10, 2020, 9:06 pm
In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).
Posted: August 10, 2020, 8:41 pm
The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale.
Posted: August 10, 2020, 8:25 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: August 10, 2020, 5:14 pm
President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.
Posted: August 7, 2020, 9:02 pm
Biotechnology
On August 9th, 2020, Viva Biotech Co., Ltd. entered into the Share Purchase Agreement pursuant to which Viva Biotech agreed to acquire and the Vendors agreed to collectively sell 80% of the equity interest in Zhejiang Langhua Pharmaceutical Co., Ltd, at the Consideration of RMB 2,560 million.
Posted: August 10, 2020, 12:00 am
Cyrus Biotechnology, Inc., announced it has developed new antibody structure prediction software, Cyrus NextGen, that is significantly more accurate than other leading methods according to a third-party test administered by BIOCAD.
Posted: August 10, 2020, 12:00 am
Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies
Posted: August 10, 2020, 12:00 am
Convalescent therapy has been touted as a fast, effective response to COVID-19, but a new therapy by GigaGen Inc. could be even more promising.
Posted: August 10, 2020, 12:00 am
- Primary endpoint met assessing safety and tolerability in the Phase 1b monotherapy portion of the study - - Preliminary results demonstrate an encouraging trend in C-peptide levels, a biomarker for T1D disease progression - - Preliminary data shows an increase in the frequency of islet-specific Tregs, a potential mechanistic indicator of therapeutic activity - [10-August-2020]
Posted: August 10, 2020, 12:00 am
Pharmaceuticals
Genomic sequencing to screen newborns raises more false alarms than routine blood tests, study finds
New research sharpens questions about whether deep genome sequencing of newborns can produce sufficiently accurate results.
Posted: August 10, 2020, 3:22 pm
As Indian regulators endorse controversial treatments for Covid-19, a group of high-profile physicians and activists is urging the government to bolster transparency surrounding all drug approvals.
Posted: August 10, 2020, 1:16 pm
One in three Americans would refuse an FDA-approved Covid-19 vaccine even if it were offered at no cost, according to a Gallup Poll.
Posted: August 10, 2020, 1:14 pm
Four years after a devastating clinical trial failure, Seres Therapeutics seems to have found success with its microbe-based treatment for C. difficile.
Posted: August 10, 2020, 10:30 am
The momentum of collective intelligence must stay strong while Covid-19 is with us, remain strong after it has faded, and provide lasting connections to the world's knowledge, know-how, and manufacturing…
Posted: August 10, 2020, 8:45 am
Human Resources
When workers get political, how can employers respond? Two federal laws, Title VII of the Civil Rights Act of 1964 and the National Labor Relations Act, offer some guidance.
Posted: August 10, 2020, 5:00 pm
EEOC alleged the test was not job-related for the position in question and consistent with business necessity.
Posted: August 10, 2020, 1:35 pm
Nonwhite women, in particular, are at risk of never returning to the workforce, according to a study.
Posted: August 10, 2020, 1:18 pm
Such requirements may be unenforceable, attorneys warned, and they also can create publicity concerns.
Posted: August 10, 2020, 12:00 pm
Assistant store managers had alleged they were misclassified as exempt from overtime pay.
Posted: August 7, 2020, 4:36 pm