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)
- Aptevo Participating in The Springtime Partnering Event, a Bio-Europe Conferenceon March 18, 2024 at 12:00 am
Aptevo Therapeutics Inc. announced that the Company is participating in The Springtime Event, a Bio-Europe conference occurring March 18-20, 2024 in Barcelona, Spain.
- BiomX Announces Closing of the Acquisition of Adaptive Phage Therapeutics and Concurrent $50 Million Financingon March 18, 2024 at 12:00 am
BiomX Inc. announced the closing of its previously announced acquisition of Adaptive Phage Therapeutics, Inc. and its previously announced $50 million private placement to certain institutional accredited investors, which was led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital.
- Tenaya Therapeutics Announces Publication of TN-401 Gene Therapy Preclinical Data in Nature Communications Medicineon March 18, 2024 at 12:00 am
Tenaya Therapeutics today announced the publication of its preclinical research related to its gene therapy candidate, TN-401, in the current issue of Nature Communications Medicine.
- GRO Biosciences Expands Executive Team with Appointment of Biopharma Veteran Tracey Lodie, PhD as Chief Development Officeron March 18, 2024 at 12:00 am
GRO Biosciences Inc., an emerging biotechnology company leveraging synthetic biology to expand the amino acid alphabet and deliver on the promise of protein therapeutics, announced the expansion of its leadership with the hire of Tracey Lodie, PhD as Chief Development Officer.
- Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussionon March 18, 2024 at 12:00 am
Oragenics, Inc. announced it has appointed Dr. James “Jim” Kelly, Neurologist, as its Chief Medical Officer, to oversee its upcoming Phase II clinical trial.
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+: Pharmalittle: We’re reading about CAR-T drugs for myeloma, CVS rebate credits, and moreby Ed Silverman on March 18, 2024 at 12:48 pm
A FDA panel voted in favor of expanding use of CAR-T therapy in multiple myeloma, despite concerns about side effects.
- STAT+: Up and down the ladder: The latest comings and goingsby Ed Silverman on March 15, 2024 at 2:45 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 a liver-drug approval, pharma’s positive outlook, and moreby Ed Silverman on March 15, 2024 at 1:25 pm
The FDA granted accelerated approval for the first medicine developed specifically to treat a serious liver disease known as MASH.
- STAT+: Pharmalittle: We’re reading about BIO cutting ties with WuXi, EU pharma rules, and moreby Ed Silverman on March 14, 2024 at 1:19 pm
The BIO industry trade group is cutting ties with China's WuXi in response to U.S. government scrutiny of the biotech and other Chinese companies.
- STAT+: Pharma loses a key battle over a state law concerning 340B pharmaciesby Ed Silverman on March 13, 2024 at 5:07 pm
A U.S. appeals court has upheld an Arkansas law that allows hospitals participating in a controversial federal discount program to ship medicines to certain pharmacies.
Human Resources
HR Dive - Latest News Human Resources and Workforce Management News
- Minimum-wage delivery drivers must be 100% reimbursed for using their own vehicles, 6th Cir. saysby Laurel Kalser on March 18, 2024 at 4:20 pm
The court didn’t say how employers should calculate these reimbursements, but it warned that underpayment may cut into a driver’s minimum wage and violate the FLSA.
- Although 80% of companies are investing in AI, half aren’t sure how to use itby Carolyn Crist on March 18, 2024 at 2:19 pm
A lack of organizational expertise, as well as employee skepticism and lagging regulations could affect AI adoption.
- Companies overestimate their employees’ trust. That’s bad for business, PwC says.by Kathryn Moody on March 18, 2024 at 2:01 pm
“The risk is not that people leave — it’s that they stay and work half-heartedly,” according to the firm's report.
- 4 things to look for in a digital staffing solution you can truston March 18, 2024 at 9:00 am
For businesses that are eager to optimize their process of finding workers (or curious about how), there are four things to look for in choosing a trustworthy solution.
- Cornell University employees ask SCOTUS to address retirement plan circuit splitby Ryan Golden on March 15, 2024 at 8:52 pm
The case concerns whether ERISA plaintiffs must “plead and prove additional elements and facts not contained” in the law’s text.