June, 2024

article thumbnail

Slideshow: Everything You Need to Know About the US Bird Flu Outbreak

Drug Topics

In a webinar conducted by the National Foundation for Infectious Diseases (NFID), experts gathered to publicly address the ongoing bird flu outbreak across many US states.

192
192
article thumbnail

STAT+: Vertex reports positive results in stem cell trial for type 1 diabetes

STAT

ORLANDO — Twelve people with type 1 diabetes who received a therapy derived from stem cells were able to produce enough of their own insulin to maintain healthy blood glucose levels 90 days later, Vertex Pharmaceuticals said Friday. All but one reduced or eliminated the need to inject insulin over those three months and three people followed for one year no longer needed to inject insulin at all.

138
138
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Study Finds Alterations in Functional Connectivity of Brain Regions in Adolescents With Internet Addiction

Pharmacy Times

The authors noted that these networks have a significant role in intellectual ability, physical coordination, working memory, emotional processing, and overall mental health.

152
152
article thumbnail

Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

FDA 135
article thumbnail

Position Your Pharmacy for Expansion

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.

article thumbnail

Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

article thumbnail

‘A mixed bag’: Fifth Circuit rules on ACA preventive services legal case

Fierce Healthcare

The Fifth Circuit Court of Appeals has issued a decision in a major legal case that observers have said could fundamentally alter the preventive services provision in the Affordable Care Act. | The Fifth Circuit Court of Appeals has issued its ruling on Braidwood Management v. Becerra, a case that has wide-ranging implications on millions of Americans.

122
122

More Trending

article thumbnail

STAT+: Gilead’s twice-yearly antiviral protected women from HIV infection in large trial

STAT

Gilead said Thursday that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected cisgender women from contracting HIV in a large Phase 3 trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV.

141
141
article thumbnail

Study Finds Asthma Severity is Not Associated With Reactivity to Allergen Skin Testing

Pharmacy Times

The findings also show that skin testing positivity for perennial allergens was higher in patients with childhood-onset asthma compared with those with adult-onset asthma.

137
137
article thumbnail

Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

Vaccines 145
article thumbnail

Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

Vaccines 144
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

2024 shaping up to be a big year for healthcare AI companies. But some investors remain cautious

Fierce Healthcare

AI deal activity is dominating healthcare investment with one in four dollars invested in healthcare going toward companies leveraging AI, according to a new report. | So far, in 2024, $2.8 billion has already been invested in AI healthcare companies, with SVB projecting the sector to see $11.

136
136
article thumbnail

Increasing Prevalence of T1D Calls for Age-Specific Clinical Guidelines of Management

Drug Topics

Clinical recommendations for the management of type 1 diabetes (T1D) in older adults are urgently needed as the global population ages and as improved diabetes care and management of complications have extended the life expectancy of the patient population.

197
197
article thumbnail

Opinion: Long Covid feels like a gun to my head

STAT

I have spent my career studying infectious diseases that fall under the heading of neglected tropical diseases. Now I have a neglected disease — long Covid — an incurable (for now and for me) disease. As a medical anthropologist working in global health, I thought I understood the despair of poor health. I didn’t. I join 7% of the U.S. adult population — or about 18 million Americans — who have experienced long Covid.

145
145
article thumbnail

Researchers Find Shared Multiomic Molecular Dysregulations in Brains With PTSD and MDD

Pharmacy Times

The investigators are optimistic that the data can establish stress-related pathways while revealing potential therapeutic options for patients with major depressive disorder and post-traumatic stress disorder.

149
149
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

article thumbnail

Can you eat popcorn if you have diabetes?

The Checkup by Singlecare

If you’re managing Type 2 diabetes , choosing foods that help regulate blood glucose levels is essential. According to the American Diabetes Association , the best food choices for people with diabetes include whole grains, lean proteins, healthy fats, and non-starchy vegetables. Foods that are high in fiber and low in sugar are good snack options for individuals with diabetes because they help prevent rapid increases in blood sugar levels, improve heart health, and assist with weight mana

111
111
article thumbnail

After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

FDA 134
article thumbnail

Color Health taps OpenAI to generate screening plans for cancer patients

Fierce Healthcare

Color Health is working with OpenAI to test out computer-generated personalized care plans for cancer patients. | Color developed a new copilot app that leverages GPT-4o to identify missing diagnostics and create tailored workup plans for patients.

130
130
article thumbnail

Pharmacy in the Digital Age

Drug Topics

The world’s information is at our fingertips, but understanding that information and applying it to patient care still requires a rigorous education.

article thumbnail

Inside Anthony Fauci’s ‘On Call’: 9 health and science takeaways from the memoir of America’s most famous doctor

STAT

Anthony Fauci spent 40 years in the top echelons of government. It was no accident. To read the forthcoming memoir by the country’s former top infectious disease expert, “On Call: A Doctor’s Journey in Public Service,” a copy of which was obtained by STAT, is to get a sense of his finesse while advising seven presidents. He strove, he writes, to speak with complete candor and stay out of politics, while remaining strategic in pushing for policies he considered vital t

144
144
article thumbnail

Study: Ultraviolet-B Radiation Could Improve Widespread Vitamin D Deficiency

Pharmacy Times

Ambient-UVB radiation could improve 25(OH)D prediction in the future, improving widespread vitamin D deficiencies among non-White individuals.

144
144
article thumbnail

NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production

Outsourcing Pharma

Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).

111
111
article thumbnail

Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults

Fierce Pharma

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

Vaccines 124
article thumbnail

Value-based care, GLP-1s: 4 takeaways from AHIP 2024

Fierce Healthcare

LAS VEGAS — Last week, leaders across the health insurance industry descended on Sin City to dig deep into the biggest topics facing payers. | LAS VEGAS — Last week, leaders across the health insurance industry descended on Sin City to dig deep into the biggest issues facing payers.

Insurance 128
article thumbnail

Cannabis to Treat Cancer: Younger Populations Reluctant to Disclose as Overall Use Becomes More Accepted

Drug Topics

Researchers addressed the use of cannabis to treat cancer symptoms in rural and urban areas, as well as patients’ comfortability discussing it with their providers.

210
210
article thumbnail

New Merck pneumococcal vaccine wins FDA approval

STAT

The Food and Drug Administration on Monday approved Merck’s new pneumococcal vaccine for adults 18 and older. The vaccine, which will be sold under the name Capvaxive, is designed to protect against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the United States every year and kills about 1 in 20 who develop it, according to the National Foundation for Infectious Diseases.

Vaccines 141
article thumbnail

Drug Shortages in Community Oncology: Ensuring Access to Chemotherapy

Pharmacy Times

Persistent chemotherapy drug shortages challenge oncology providers. American Oncology Network employs a drug shortage committee for organized shortage management that involves pharmacists and interdisciplinary stakeholders.

article thumbnail

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

The FDA Law Blog

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

Dosage 116
article thumbnail

Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

Vaccines 128
article thumbnail

National Nurses United pushes back against deployment of ‘unproven’ AI in healthcare

Fierce Healthcare

The nation’s largest nurses union is demanding that artificial intelligence tools used in healthcare be proven safe and equitable before deployment. | A union organization for nurses nationwide says the deployment of AI in healthcare will push nurses out of patient rooms and compromise patient safety. A new AI Bill of Rights lays out nurse and patient protections, which are not currently being met.

137
137
article thumbnail

Value-Based Care Models Can Help Pharmacies Improve Operations

Drug Topics

Sandra C. Canally, RN, founder and CEO of The Compliance Team, discussed the goals, benefits, and opportunities of value-based care in pharmacy.

201
201
article thumbnail

Global health leader critiques ‘ineptitude’ of U.S. response to bird flu outbreak among cows

STAT

LONDON — Seth Berkley, a longtime and widely respected global health leader , said Thursday that it has been “shocking to watch the ineptitude” of the U.S. response to the avian influenza outbreak among dairy cattle , adding his voice to a chorus of critics. In a presentation in London about vaccine development, Berkley, the former CEO of Gavi, the Vaccine Alliance, raised the issue of H5N1 bird flu when discussing whether the world was ready for another pandemic following i

Vaccines 145
article thumbnail

Navigating the Deluge of Clinical Literature During and After COVID-19: Insights From ASHP Pharmacy Futures 2024

Pharmacy Times

Speakers at American Society of Health-System Pharmacists (ASHP) Pharmacy Futures 2024 discuss the significant increase in published clinical literature during and after the COVID-19 pandemic, and the evolving role and reliability of AI tools such as ChatGPT in providing accurate medical information.

138
138
article thumbnail

Pharmacogenomics and IVDR: Overcoming transition challenges

pharmaphorum

Understanding the challenges and opportunities in transitioning to IVDR for pharmacogenomics can be complex. Learn more about how to overcome these challenges effectively.

124
124
article thumbnail

In fight against knockoff weight loss meds, Eli Lilly accuses sellers of 'deceptive' advertising

Fierce Pharma

Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. | Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. The Indianapolis-based drugmaker is suing six wellness centers, medical spas and others that it claims are using "deceptive" advertising.