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)
- FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Diseaseon April 25, 2024 at 12:00 am
Medivir AB, a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation as well as Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease.
- PRISM BioLab, enters into a Joint Research and Licensing Agreement with Onoon April 25, 2024 at 12:00 am
PRISM BioLab, Co. Ltd. announced that it has entered into a target-exclusive research and licensing agreement with ONO PHARMACEUTICAL CO., LTD.
- Invitae Enters into Agreement with Labcorp for Sale of Businesson April 25, 2024 at 12:00 am
Invitae, a leading medical genetics company, announced that Labcorp, a global leader of innovative and comprehensive laboratory services, has been selected as the winning bidder in the Company's auction in its sale process under Section 363 of the U.S. Bankruptcy Code.
- GenScript Biotech Releases 2023 ESG Report: Deepening Green Development Practices, Constructing Sustainable Future Blueprinton April 24, 2024 at 12:00 am
Recently, GenScript Biotech Corporation, a world leader in technologies and services for life science R&D and manufacture, released its 2023 Environmental, Social, and Governance report.
- AffyImmune Announces Presentation on Affinity-Tuned CAR T Therapy AIC100 at ASCO 2024on April 24, 2024 at 12:00 am
AffyImmune Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced an abstract detailing its affinity-tuned CAR T therapy AIC100 will be presented at the American Society of Clinical Oncology 2024 Annual Meeting, held May 31-June 4, at McCormick Place Convention Center in Chicago, IL.
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+: 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.
- STAT+: Pharmalittle: We’re reading about GLP-1 spending, biosimilar patient costs, and moreby Ed Silverman on April 24, 2024 at 1:17 pm
Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and they're set to cost the U.S. health care system and the federal government still more.
- STAT+: Biosimilars haven’t always yielded lower out-of-pocket costs for patients, study findsby Ed Silverman on April 24, 2024 at 11:48 am
The authors of a new study argue the heralded arrival of biosimilars failed to fully deliver on their promise.
- STAT+: Pharmalittle: We’re reading about Lilly buying a plant, a Pfizer antibiotic, and moreby Ed Silverman on April 23, 2024 at 1:43 pm
Eli Lilly agreed to acquire a manufacturing facility in Wisconsin from Nexus Pharmaceuticals to produce injectable medicines amid shortages of Mounjaro and Zepbound.
- STAT+: Pharmalittle: We’re reading about an OptumRx contract, 340B dispute resolution, and moreby Ed Silverman on April 22, 2024 at 1:24 pm
Cardinal Health announced its pharmaceutical distribution contracts with UnitedHealth's OptumRx unit will not be renewed after they expire in June.
Human Resources
HR Dive - Latest News Human Resources and Workforce Management News
- Delta Air Lines raises starting wage to $19 per hour, increases pay by 5%by Emilie Shumway on April 24, 2024 at 8:24 pm
The pay raise comes amid a union-organizing campaign among the company’s flight attendants.
- US Chamber sues to block FTC noncompete banby Ryan Golden on April 24, 2024 at 8:11 pm
The commission’s final rule is outside the scope of the authority granted by Congress, the Chamber alleged Wednesday.
- DOL’s ‘unprecedented,’ two-pronged overtime rule adds new HR wrinklesby Ryan Golden on April 24, 2024 at 8:06 pm
Employers must decide whether to incrementally comply with the rule’s salary threshold updates or move straight to compliance with the higher 2025 threshold, attorneys told HR Dive.
- Citi failed to protect managing director from sexual harassment, lawsuit claimsby Rajashree Chakravarty on April 24, 2024 at 7:34 pm
Ardith Lindsey filed additional details Monday in her lawsuit against the bank regarding a supervisor’s threats against her and her family.
- How does remote monitoring work? Here’s what HR needs to know.by Caroline Colvin on April 24, 2024 at 3:29 pm
Many workers may not be aware that such monitoring is taking place — and that poses a culture problem.