Tag: pharmalittle

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cup of stimulation, which we hope to find shortly since we are on the road. Perhaps we can meet? Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips, and criticism. …

Martin Shkreli is back, but the U.S. Federal Trade Commission is not happy, STAT says. The agency and seven states asked a U.S. court to hold Shkreli in contempt for “flagrantly and repeatedly” violating a court order banning him from working in the pharmaceutical industry. Shkreli, known as “pharma bro” for imperiously defending his decision to raise the price of a drug by 5,000%, was sentenced to seven years in prison for defrauding investors in 2018. Before his release in 2022, a court banned him from ever working in the industry again, saying he illegally tried to prevent generic competition to the drug. Since then, he became a prolific trader in pharma stocks, broadcasting his analysis in posts and livestreams on X and other platforms.

European Union antitrust regulators accepted concessions from Sanofi to settle an investigation into an allegedly “misleading” campaign that disparaged the only rival flu vaccine recommended for vulnerable patients at risk for developing the illness, STAT tells us. In doing so, the company avoided being fined. The European Commission had suggested that Sanofi portrayed the Fluad vaccine marketed by CSL Seqirus as inferior to its own Efluelda vaccine in a communication campaign that primarily targeted health care professionals in Germany and France. Sanofi holds a dominant position in both countries, according to the EC.

Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. As for the official mascots, they are happily snoozing in their respective corners. As for us, we are firing up the trusty kettle for another cup of stimulation. Our choice today is butter pecan. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few items of interest. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

Two months after the release of an open letter on potential safety issues tied to a rare disease drug sold by Neurocrine Biosciences, patient advocates and some experts are expressing growing alarm over the perceived risks of the therapy, STAT reports. The drug, approved to treat Prader-Willi syndrome, which can cause an insatiable feeling of hunger, has been linked to the deaths of seven people and the  hospitalization of nearly 100 others — all since the treatment, called Vykat XR, was approved 18 months ago. Case reports on those deaths and hospitalizations that were submitted to regulators do not prove causality; many of the Vykat cases involved complex medical issues and multiple medications. But some experts say the evidence is sufficient to conclude Vykat is causing unacceptable harm.

The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, STAT writes, citing a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice. In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices.

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips, and criticism. …

The World Health Organization released its first guidelines addressing the sharp rise in obesity among children and adolescents, Health Policy Watch says. In 2024, 170 million children and adolescents aged 5–19 years were living with obesity, including 70 million children aged 5 to 9 years and 100 million adolescents aged 10 to 19 years. Obesity prevalence in this age group quadrupled since 1990, rising from 2% to 8%. But the WHO does not recommend pharmacological treatment, bariatric surgery, or weight loss devices for children aged 0 to 9 years. For adolescents aged 10 to 19 years, treatment with approved drugs may be considered only when a supervised multimodal lifestyle program has not achieved desired results.  

Caribou Biosciences is shutting down after failing to raise the money necessary to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma, STAT notes. The biotech, borne from the research lab of CRISPR scientist and Nobel laureate Jennifer Doudna, will discontinue clinical development of its two CRISPR-based CAR-T therapies, including vispa-cel for the treatment of advanced B-cell non-Hodgkin lymphoma. Over the past year, Caribou had worked successfully with the Food and Drug Administration to finalize the design of a Phase 3 trial for vespa-cel. Unfortunately, raising the money to pay for the study proved too difficult.

Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. As for the official mascots, they are happily snoozing in their respective corners. As for us, we are firing up the trusty kettle for another cuppa stimulation. Our choice today is honeybush vanilla turmeric. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few items of interest. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

The Trump administration is advancing the first government-funded clinical trials of the psychedelic drug ibogaine to treat opioid addiction and ​post-traumatic stress disorder, Reuters says. The initiative ⁠follows an executive order signed last April by President Trump that dedicated $50 million ​to the federal ibogaine research, as well as recent calls by experts and ​veterans for strict safety standards on psychedelic treatments. The U.S. Food and Drug Administration said it has opened a public docket seeking feedback on trial design, dose selection, patient ​eligibility, safety monitoring, study-stopping rules, and oversight by Nov. 20.

AstraZeneca’s pivot towards the U.S. market has continued with the opening of a new R&D center in the biotech hotspot of Cambridge, Mass., the centerpiece of a $1 billion investment program in the state, Pharmaphorum explains. The new facility in the Kendall Square area — which is one of the densest biotech clusters in the world, with hundreds of small and large biopharma companies present — covers 570,000 square feet of lab and office space over 18 stories. The center is part of a major investment program by the U.K.-based company that was first announced in 2024 and dramatically expanded to around $50 billion last year.