Regulatory Affairs
Pharmaceutical trading partners are behind the curve in exchanging electronic product information with each other under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires these exchanges go live by 27 November 2023.
Posted: September 24, 2021, 7:15 pm
The US Food and Drug Administration is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe and effective (GRASE) for marketing.
Posted: September 24, 2021, 6:43 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: September 24, 2021, 5:22 pm
The process used by the US Food and Drug Administration to vet new drugs and biologics is inconsistent in borderline cases and fails to rely on evidence standards used in previous decisions, according to findings from a case series that examined the process across 22 "close call" applications in recent years.
Posted: September 23, 2021, 9:13 pm
Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one of the led the US Food and Drug Administration (FDA) to issue two warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.
Posted: September 23, 2021, 7:50 pm
Biotechnology
Targovax ASA, a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, announce that the European Patent Office has granted EU Patent no EP3402889.
Posted: September 24, 2021, 12:00 am
Reven Holdings Announces Successful Completion of the First Part of RPI015 Clinical Trial Evaluating Its Lead Anti-sepsis Drug Candidate RJX in Hospitalized High-risk COVID-19 Patients
Posted: September 24, 2021, 12:00 am
Capricor Therapeutics, a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced positive final data from the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of Duchenne muscular dystrophy.
Posted: September 24, 2021, 12:00 am
Life sciences organizations strengthen their leadership teams and boards with these Movers & Shakers.
Posted: September 24, 2021, 12:00 am
The United States has seen companies launching left and right. Check out the top 10 biopharma Series A rounds in the U.S. so far this year.
Posted: September 24, 2021, 12:00 am
Pharmaceuticals
The World Health Organization added a Regeneron medication to its list of recommended treatments for Covid-19, but also criticized the company's pricing and distribution of the drug.
Posted: September 24, 2021, 8:46 pm
The Biden administration’s careening rollout of Covid-19 booster shots has pitted key public health officials against their own scientific advisers.
Posted: September 24, 2021, 6:40 pm
The process used by the Food and Drug Administration to vet new drugs and biologics is inconsistent in borderline cases.
Posted: September 24, 2021, 5:25 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Posted: September 24, 2021, 5:03 pm
The inaugural trio of commercial spaceflights represent a new era of space health research that will benefit all humans exploring space as well as those who stare up at it…
Posted: September 24, 2021, 8:45 am
Human Resources
The appellate court reversed a portion of a lower court’s ruling that Rowan University did not retaliate against a professor for taking leave.
Posted: September 24, 2021, 2:38 pm
An audit by applicant tracking system Jobvite shows how Fortune 500 companies are failing potential hires.
Posted: September 24, 2021, 1:45 pm
"Nobody is interested in coming to a party they think is being thrown for someone else," one speaker said during SHRM21.
Posted: September 24, 2021, 1:19 pm
The rule addresses fines for accidental or first-time offenses and is expected to take effect in late November.
Posted: September 23, 2021, 5:53 pm
In removing salary history requests from its hiring process, Ingka Group joins a growing movement for pay equity.
Posted: September 23, 2021, 2:04 pm