Regulatory Affairs
Federal criminal charges have been filed against a man previously warned by the FDA for peddling unproven and unauthorized “vaccines” against COVID-19.
Posted: January 22, 2021, 10:49 pm
Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.
Posted: January 22, 2021, 10:23 pm
Updated 22 January to include new information on brilacidin, convalescent plasma, bamlanivimab, Ilaris, Humira, and ivermectin.
Posted: January 22, 2021, 9:06 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: January 22, 2021, 8:14 pm
Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.
Posted: January 21, 2021, 11:09 pm
Biotechnology
Vancouver, British Columbia--(Newsfile Corp. - January 22, 2021) - Entheon Biomedical Corp. (CSE: ENBI) (OTC Pink: ENTBF) (FSE: 1XU1) ("Entheon" or the "Company"), a biotechnology company focused on developing psychedelic medicines to treat addiction, is pleased to announce its inclusion in the Horizon North American Psychedelic ETF, the first ever psychedelic ETF of its kind.
Posted: January 22, 2021, 12:00 am
ATVenture Center, LLC, announced today that its Sanatela cancer biotechnology subsidiary has moved into a 2,000 square foot clean room space in Fairport, NY and will begin ramping up production of the Sanatela MatrixTM, an advanced biomaterial that can be used as a tool for early cancer detection and treatment.
Posted: January 22, 2021, 12:00 am
Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response therapeutics for the treatment of cancer, announced that the first patient has enrolled into an investigator-initiated trial of its investigational drug, Silmitasertib, as a treatment for hospitalized COVID-19 patients at Banner Health-University Medical Center in Phoenix, Arizona.
Posted: January 22, 2021, 12:00 am
One year and more than 410,000 deaths later, the United States is still firmly in the grips of the COVID-19 pandemic.
Posted: January 22, 2021, 12:00 am
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the release of its inaugural ESG Report, which details the company’s commitments and efforts to build strong corporate governance, and operate sustainably and responsibly, including its response to the COVID-19 pandemic and prevailing social issues in 2020.
Posted: January 22, 2021, 12:00 am
Pharmaceuticals
Outside experts said the data, provided by press release, were too limited to draw conclusions, though they hoped that colchicine, a generic medicine with manageable side effects, would prove to…
Posted: January 23, 2021, 8:49 pm
There is no time machine that would allow us to return to January 24, 2020. But it is not too late to recognize the blunder about asymptomatic infection and aggressively…
Posted: January 23, 2021, 12:00 pm
EXCLUSIVE: PhRMA sued to block a Trump administration rule aimed at helping drug makers and health care providers resolve disputes related to the 340B program.
Posted: January 23, 2021, 1:24 am
The CDC reported Friday that Moderna's Covid-19 vaccine appears to induce rare anaphylactic reactions in a small number of people.
Posted: January 22, 2021, 6:00 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: January 22, 2021, 3:25 pm
Human Resources
The president also asked the agency to reconsider its decision to skip emergency temporary standards.
Posted: January 22, 2021, 6:44 pm
Despite bank exec's alleged ageist comments, teller's termination wasn't based on age, 6th Cir. says
The employer presented evidence that the teller was fired for insubordination, the court explained.
Posted: January 22, 2021, 4:38 pm
While market recovery seems to be in progress, the pandemic's effects will likely be felt for years to come, experts at Randstad said.
Posted: January 22, 2021, 3:44 pm
"Identifying business-critical technologies and preparing for their failure is vital," according to a Hogan Lovells executive.
Posted: January 22, 2021, 3:09 pm
The new administration's more labor friendly stance is "apt to make supposed wage theft its enforcement priority," the report said.
Posted: January 21, 2021, 5:09 pm