Regulatory Affairs
Eye on FDA RX for Pharma Industry Communications and Planning
- FDA Adds New AdComm to Address Genetic Metabolic Diseasesby Mark Senak on March 7, 2024 at 4:05 pm
Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, … Continue reading →
- What They Said – FDA Press Releases in 2023by Mark Senak on February 8, 2024 at 1:27 pm
Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency … Continue reading →
- FDA’s OPDP Sends First Regulatory Letter of the Year Aimed at Rx Drug Promotionby Mark Senak on January 22, 2024 at 7:39 pm
Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … Continue reading →
- The Year in AdComms – A Look Back at 2023by Mark Senak on December 7, 2023 at 7:15 am
For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more … Continue reading →
- FDA’s OPDP Issues Two New Untitled Lettersby Mark Senak on November 10, 2023 at 7:01 am
While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading →
Biotechnology
Biotechnology Industry News | BioSpace RSS Feed for Biotechnology Industry News | BioSpace (Generated by New Sloth)
- Medigene AG reports Financial Results and Business Update for Q1 2024on April 26, 2024 at 12:00 am
Medigene AG, an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the first quarter of 2024.
- Krystal Biotech to Report First Quarter 2024 Financial Results on May 6, 2024on April 26, 2024 at 12:00 am
Krystal Biotech, Inc., a commercial-stage biotechnology company, announced that it will report its first quarter 2024 financial results on Monday, May 6, 2024, prior to the open of U.S. markets.
- Allogene Therapeutics Awarded Grant from the California Institute for Regenerative Medicine to Advance Development of an Allogeneic CAR T in Renal Cell Carcinomaon April 26, 2024 at 12:00 am
Allogene Therapeutics, Inc. announced that it has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of ALLO-316, an AlloCAR T™ investigational product targeting CD70 in development for the treatment of advanced or metastatic renal cell carcinoma (RCC).
- Bio-Techne and Novomol-Dx Announce Point-of-Care Ocular Biomarker Assayon April 26, 2024 at 12:00 am
Bio-Techne Corporation and Novomol-Dx, a molecular diagnostics company, are pleased to announce the development of Bio-Marker Pathfinder, a first of its kind ocular biomarker kit, as a point-of-care application.
- AbbVie Raises 2024 Profit Outlook, Reports Strong Q1 Sales for Skyrizi and Rinvoqon April 26, 2024 at 12:00 am
Humira maintained its blockbuster status and market share dominance in the first quarter of 2024, but experienced a drop in sales as biosimilar competition heated up, AbbVie reported on Friday.
Pharmaceuticals
STAT Pharmalot: Insight and analysis by Ed Silverman Ed Silverman began writing Pharmalot at The Star Ledger of New Jersey in 2007 and it continues to this day at STAT. He joined STAT at its founding in 2015, coming from the Wall Street Journal. He has covered the pharmaceutical industry since 1995. For more insights and analysis, bookmark this page or sign up for his newsletter here.
- STAT+: Up and down the ladder: The latest comings and goingsby Ed Silverman on April 26, 2024 at 4:56 pm
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
- STAT+: Pharmalittle: We’re reading about Cigna biosimilar plans, a Vertex deal in South Africa, and moreby Ed Silverman on April 26, 2024 at 1:45 pm
Cigna plans to make copies of AbbVie's Humira arthritis drug available with no out-of-pocket payment to eligible patients in the U.S.
- STAT+: Vertex offers limited access to a cystic fibrosis drug in South Africa — and may undercut a court caseby Ed Silverman on April 25, 2024 at 8:51 pm
"This is not a solution for all South African patients” and is “likely to widen the disparity between rich and poor,” advocates complained.
- STAT+: Pharmalittle: We’re reading about a Senate probe into Novo pricing, a new UTI antibiotic, and moreby Ed Silverman on April 25, 2024 at 1:28 pm
The U.S. Senate health committee is investigating the prices Novo Nordisk charges for its blockbuster medications Ozempic and Wegovy.
- STAT+: Colombia issues a compulsory license for an HIV medicine and ‘plants a flag for global health equity’by Ed Silverman on April 25, 2024 at 12:22 am
“Colombia is planting a flag for global health equity,” said Peter Maybarduk, who heads the access to medicines campaign at Public Citizen.
Human Resources
HR Dive - Latest News Human Resources and Workforce Management News
- 17 states sue to block EEOC pregnancy accommodation ruleby Ryan Golden on April 26, 2024 at 7:15 pm
The rule’s abortion accommodation provisions conflict with the Pregnant Workers Fairness Act, the plaintiffs, led by Tennessee, alleged.
- Men more likely to say in-office work improves visibility to leadershipby Carolyn Crist on April 26, 2024 at 2:18 pm
Regardless of remote, hybrid or in-person schedules, all workers should receive equal access to training and mentoring opportunities, AMA says.
- Wells Fargo saleswoman alleges she was held to ‘entirely different standard’ in ‘boys club’ workplaceby Ginger Christ on April 25, 2024 at 8:05 pm
The worker alleged her employer gave large, more profitable accounts to her male colleagues because they were “sole breadwinners,” while she was a “second income” for her husband.
- Chipotle, Starbucks have highest burnout among major restaurants: studyby Aneurin Canham-Clyne on April 25, 2024 at 7:23 pm
Chipotle, which recently added new worker benefits to attract hires, had the second-highest burnout rating of any company in the study, surpassed only by Progressive.
- DHL will pay $8.7M to settle allegations it gave Black workers more dangerous assignmentsby Caroline Colvin on April 25, 2024 at 6:54 pm
The Civil Rights Act of 1964 was signed 60 years ago this July; “Some employers still fail to get the message," the EEOC chair said in a statement.