Pharmacy Times
NOVEMBER 15, 2023
Taurolidine and heparin (Defencath; CorMedix) is indicated to reduce catheter-related bloodstream infections for adults with kidney failure who are receiving chronic hemodialysis via central venous catheter
STAT
NOVEMBER 15, 2023
The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country. The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing.
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Pharmacy Times
NOVEMBER 15, 2023
Session speaker Powell-Wiley explains how screening for SDOH in patients as cardiovascular-kidney-metabolic syndrome stages progress can help better understand their individual social needs.
STAT
NOVEMBER 15, 2023
Step inside Natasha Sheybani’s office at the University of Virginia, where she runs a bioengineering lab, and you’ll find a kaleidoscopic sea of sticky notes. She uses purple for ideas sparked by meetings, orange for future grant proposals. But she’s most excited about the yellow stickies, which Sheybani saves for moonshots: projects that are high-risk and high-reward.
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
Fierce Pharma
NOVEMBER 15, 2023
In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.
Fierce Healthcare
NOVEMBER 15, 2023
Primary care player Forward unveiled this week what it has been quietly working on the past two years—self-serve CarePods that use artificial intelligence to screen and diagnose health conditions.< | Primary care player Forward unveiled this week what it has been quietly working on the past two years—self-serve CarePods that use artificial intelligence to screen and diagnose health conditions.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
Fierce Healthcare
NOVEMBER 15, 2023
UnitedHealthcare is facing a potential class action lawsuit following allegations that it used an algorithm to deny claims for post-acute care services in Medicare Advantage. | UnitedHealthcare is facing a potential class action lawsuit following allegations that it used an algorithm to deny claims for post-acute care services in Medicare Advantage.
Pharmacy Times
NOVEMBER 15, 2023
In this episode, you'll hear a conversation with Ron Lanton, partner at Lanton Law, who gets us up to speed on all of the legal cases surrounding this issue thus far.
STAT
NOVEMBER 15, 2023
WASHINGTON — House lawmakers late Tuesday voted to attach a U.S. ban on controversial infectious disease research to legislation that could ultimately fund federal health agencies like the National Institutes of Health. The bill would bar any federal agencies from funding so-called gain-of-function research, which involves altering a pathogen to study its spread, potentially making it more transmissible or severe in the process.
Pharmacy Times
NOVEMBER 15, 2023
The business model took time to catch up to pharmacy’s potential, and community-based patient care leads the way
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Drug Topics
NOVEMBER 15, 2023
Presenters at a NCPA 2023 session highlighted the importance of overcoming hesitations to implement new clinical services and taking an employee-centric approach in doing so.
STAT
NOVEMBER 15, 2023
One day in early 2020, just weeks before Philadelphia entered lockdown, Thomas Jefferson University’s public safety lead Joseph Byham abandoned a brisk walk to respond to an urgent incident. A clinician at one of Jefferson’s Center City hospitals had pressed a badge-worn button summoning security immediately: a traumatic brain injury patient was attempting to flee, and they feared it would escalate into violence.
Drug Topics
NOVEMBER 15, 2023
Compounding parenteral nutrition solutions is a complex process with a high risk for error, which can lead to serious adverse outcomes.
Pharmacy Times
NOVEMBER 15, 2023
Investigators believe that the activation of mast cells drives inflammation and contributes to plaque buildup, causing heart attacks and other damage to the heart.
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STAT
NOVEMBER 15, 2023
Convenience is rapidly becoming a guiding principle for hospital system strategy and competition. As patients demand a more convenient, integrated care experience, and new partnerships/acquisitions (for instance, CVS Health and Oak Street Health, or Amazon and One Medical) redefine what the consumer health care journey looks like, the industry will continue to see a collision between virtual, at-home, and in-person care.
Pharmacy Times
NOVEMBER 15, 2023
The genes that predispose a person to sleep problems can impact that person across their entire lifetime, so interventions targeted toward a younger audience could be beneficial.
Fierce Healthcare
NOVEMBER 15, 2023
Postmeds, doing business as Truepill, confirmed that hackers accessed the personal data of more than 2.3 million patients. | Postmeds, doing business as Truepill, confirmed that hackers accessed the personal data of more than 2.3 million patients.
STAT
NOVEMBER 15, 2023
WASHINGTON — Panels in both the House and Senate have now passed restrictions to drug middlemen business practices, increasing the chances of those measures being included in future government spending bills. The bipartisan reforms to pharmacy benefit managers were among 21 bills that the House Energy & Commerce health subcommittee passed today.
Drug Topics
NOVEMBER 15, 2023
A study found that around 75% of children who had reported experiencing pollen-AR by the ages of 4 or 8 continued to have persisted in their condition until they reached 24 years of age.
STAT
NOVEMBER 15, 2023
LONDON — Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world. A study published Wednesday backs up the idea that they can.
Fierce Healthcare
NOVEMBER 15, 2023
Summer Health launched a year ago as a text-based service for parents to get answers to urgent needs from pediatricians. | There is a growing shortage of pediatric clinicians. To meet the demand for primary care services, Summer Health rolled out a new on-demand text message service for parents to connect with pediatricians, sleep coaches and lactation experts.
STAT
NOVEMBER 15, 2023
The patents on medicines and devices approved by the U.S. Food and Drug Administration were more frequently invalidated due to information misrepresented or withheld from patent examiners than any other industry sector, according to a new analysis. Between 2004 and 2021, a U.S. appeals court that handles patent litigation found 36 cases in which companies committed what is called inequitable conduct — failing to provide accurate or complete information to the U.S.
Fierce Pharma
NOVEMBER 15, 2023
If you’re curious about the pitfalls of CAR-T drug commercialization, look no further than Bristol Myers Squibb’s Abecma partner 2seventy bio. | After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.
PharmExec
NOVEMBER 15, 2023
Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.
STAT
NOVEMBER 15, 2023
WASHINGTON — There’s about to be a new acronym in town. The Food and Drug Administration is in the final stages of cementing sweeping changes to the Office of Regulatory Affairs, which oversees inspections and compliance for all its regulated products, according to three people familiar with the planning. That overhaul includes a new name: Meet the Office of Inspections and Investigations.
Fierce Pharma
NOVEMBER 15, 2023
How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? | How popular have Novo Nordisk’s semaglutide drugs become for weight loss in Europe? The craze is such that Germany’s drug regulator is considering banning the export of Ozempic, according to a report in Der Spiegel magazine.
Pharmacy Times
NOVEMBER 15, 2023
The drug may be a risk factor for dementia-related illnesses.
Fierce Pharma
NOVEMBER 15, 2023
CorMedix went through a lot to secure its FDA approval for DefenCath. | CorMedix went through a lot to secure its FDA approval for DefenCath. There was a reorganization, a CEO change, an exit from Europe, two complete response letters and a switch of manufacturers and suppliers. And it took a novel pathway for the approval to finally come through on Wednesday.
STAT
NOVEMBER 15, 2023
For the many high-achieving perfectionists who enter medical school each year, the stakes of their success have never been higher. Becoming a doctor means lives will be in their hands — and failing to make it through med school means they’ll be stuck with an unthinkable amount of debt without a viable way to pay for it. It’s no wonder that medical students suffer greatly from burnout and mental health struggles.
Pharmacy Times
NOVEMBER 15, 2023
Researchers provided recommendations based on the current status of COVID-19 infection and role of therapies.
STAT
NOVEMBER 15, 2023
A gene therapy study, halted when four children with a rare neuromuscular disorder died after treatment, showed enough promise to merit finding a path forward, according to the medicine’s manufacturer. The treatment, made by the Japanese pharmaceutical company Astellas, led to severe and fatal liver problems for four of the 24 treated children with X-linked myotubular myopathy, or XLMTM, a genetic disease that severely degrades muscle function and kills most patients before the age of 10.
PharmExec
NOVEMBER 15, 2023
Pharm Exec’s 19th annual report on the trends of the day in drug development examines the surging investment in new treatments and advances for so-called “first-world” conditions, capturing the landscape of five expanding therapeutic areas: weight loss, osteoarthritis, Alzheimer’s disease, COPD, and psychedelics.
STAT
NOVEMBER 15, 2023
WASHINGTON — The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. Richard Pazdur, director of the FDA Oncology Center of Excellence, hates bureaucracy. It stifles his ideas for getting treatments to cancer patients faster — of which there are many.
European Pharmaceutical Review
NOVEMBER 15, 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq ® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types.
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