Fri.Aug 02, 2024

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Pancreatic Cancer Dendritic Cell Vaccine Receives FDA Fast Track Designation

Drug Topics

The technology from Diakonos Oncology initiates a natural immune response that targets and eliminates cancer cells by activating cytotoxic TH1 cell signaling pathways.

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CDC Recommends International Travelers Receive MMR Vaccination 2 Weeks Prior to Travel

Pharmacy Times

The CDC says that even if travel is less than 2 weeks away, unvaccinated individuals should still receive a dose of the measles, mumps, and rubella vaccine for protection against the disease.

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Opinion: The coronavirus lab leak hypothesis is damaging science

STAT

Where and when the Covid-19 pandemic began — in Wuhan, China in late 2019 — is well known. How it began is a matter of heated controversy. There are two competing hypotheses, one of which is hindering the process of scientific discovery and could hold back the development of vaccines and other antiviral agents in the U.S. The zoonosis hypothesis proposes that SARS-CoV-2, the virus that causes Covid-19, was naturally transmitted from an animal to one or more humans in a so-called we

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Expert: The Definition of Alzheimer Disease is Shifting From Clinical to Biological

Pharmacy Times

Edward B. Lee, MD, PhD, also describes how understanding Alzheimer disease requires the integration of multiple fields including genetics, pathology, epidemiology, pharmacology, and physiology.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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STAT+: UnitedHealth and HCA clash over hospital chain’s rates in ‘battle of the giants’

STAT

Contract disputes between hospitals and health plans have become routine, but they tend to be local , affecting a handful of hospitals and the people in the surrounding communities. This latest one is different. It involves the country’s biggest private health insurer, UnitedHealthcare, and its biggest hospital chain, HCA Healthcare. If they can’t strike a deal on prices by Sept. 1, 38 hospitals and their affiliated physician groups and surgery centers across four states — T

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Vertex lifts sales guidance as launch of gene therapy Casgevy picks up steam

Fierce Pharma

As growth in Vertex's cystic fibrosis portfolio buoys the company amid the launch of gene therapy Casgevy, the company is feeling confident enough to boost its revenue outlook for the year. | As of mid-July, around 20 patients completed the first step of Casgevy treatment by having their cells collected, up from five patients during the first quarter.

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Pharmacists’ Ability to Close Gap in Delivery of Oral Anticoagulation Therapy

Drug Topics

Researchers aimed to discover whether pharmacist-led delivery of oral anticoagulation therapy can lead to an increase in stroke risk reduction for patients with actionable atrial fibrillation.

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What we do and don’t know about the shortage of blood culture bottles

STAT

In July, federal health officials warned hospitals that there would be a critical shortage of blood culture bottles that will stretch into September. Blood culture bottles are key in diagnosing sepsis, a deadly infection of the bloodstream caused by a number of different bacteria. According to the Centers for Disease Control and Prevention, about half of U.S. labs get their bottles from a company known as BD, the supplier that is in shortage, meaning that the shortage could have big implications

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FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor

Fierce Pharma

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

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Opinion: ACL tears in women: Too many injuries and too little research

STAT

Some of the world’s finest athletes were sidelined by a torn anterior cruciate ligament (the ligament that helps stabilize the knee joint) long before the torch was lit for the Paris Olympics. The list of women competitors with ACL tears is stunning. Basketball player Cameron Brink , rugby medalist Shiray Kaka, gymnast Asia D’Amato, and several other athletes will not be competing because of this all-too-common, season-ending, and potentially career-ruining injury.

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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.

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2-Drug Regimen Shows Comparable Effectiveness With 3-Drug Regimen to Treat HIV-1

Pharmacy Times

Dolutegravir/lamivudine was non-inferior to bictegravir/emtricitabine/tenofovir alafenamide fumarate, meeting the study’s primary end point.

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STAT+: FDA approves innovative T cell immunotherapy for rare soft-tissue cancer

STAT

LONDON — U.S. regulators have authorized a cutting-edge treatment relying on T cells for a rare cancer that arises in the body’s soft tissues, extending the power of immunotherapies to difficult-to-reach sarcomas.   The medicine, called Tecelra and developed by Adaptimmune Therapeutics, is what’s known as a T cell receptor therapy.

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Intravenous Immunoglobulin Effective in Achieving Viral Clearance, Neutralizing Several SARS-CoV-2 Variants

Pharmacy Times

In an analysis of 16 immunocompromised patients with COVID-19, intravenous immunoglobulin was effective and associated with clinical cure.

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Q&A: Understanding Benefits, Managing Adverse Effects of GLP-1 Receptor Agonists

Drug Topics

These therapies are highly beneficial, but can come with a host of gastrointestinal adverse effects that patients may not be prepared to manage alone.

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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.

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BLZ945 Offers New Possibilities for Eradicating HIV From the Brain

Pharmacy Times

The experimental drug successfully reduced levels of SIV, the nonhuman primate equivalent of HIV, in the brain.

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Opinion: Address liquid biopsy disparities today to ensure equity in outcomes tomorrow

STAT

The promise of scientific and medical innovation often comes with a downside: improvements in care benefit some people, but not all. Without concerted effort, that is exactly what could happen with liquid biopsy — an evolving technology aimed at improving cancer care using just a few milliliters of blood or other body fluids. Liquid biopsy technologies are maturing at a rapid pace.

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FDA Approves MAGE-A4 IHC 1F9 pharmDx as Diagnostic Tool in Patients With Synovial Sarcoma

Pharmacy Times

The diagnostic tool can aid the identification of patients with synovial sarcoma who may be eligible for treatment with newly approved afamitresgene autoleucel.

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STAT+: 23andMe board rejects co-founder Anne Wojcicki’s offer to take company private

STAT

A special committee of the board of directors of 23andMe rejected an offer from the company’s co-founder and CEO, Anne Wojcicki, to take the company private. In a letter made public Friday, the board said that Wojcicki’s proposal failed to offer a premium to 23andMe’s current stock price, did not have committed financing from other investors, and came with other conditions it rejected.

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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.

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Benefits of GLP-1s Transcend Simple Weight Loss for Individuals With Overweight, Obesity, and Comorbidities

Drug Topics

Losing even 5% of body weight can improve comorbid conditions and other health complications for individuals with overweight and obesity.

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Moderna is still in a Covid hangover

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning and happy Friday. We discuss a new innovative immunotherapy, and we take a look at some of the earnings highlights yesterday.

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Lilly gets first heart outcomes readout with tirzepatide

pharmaphorum

Eli Lilly's dual GLP-1/GIP agonist tirzepatide has been shown to reduce the risk of worsening disease in people with heart failure and obesity in a phase 3 trial, the first to show a benefit on cardiovascular outcomes with the drug.

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FDA Grants Accelerated Approval to First Engineered Cell Therapy for Synovial Sarcoma

Drug Topics

Afami-cel is the first new treatment for synovial sarcoma in more than 10 years, ending a long-standing therapeutic gap.

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Building a future-ready digital workforce in pharma

pharmaphorum

Discover how digital transformation is reshaping the pharmaceutical industry and learn how to prepare your workforce for the future with this guide on building a future-ready digital workforce in pharma.

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Managing “Class Action” Adverse Effects Crucial for GLP-1 Medication Adherence

Drug Topics

Some patients may have difficulty managing the gastrointestinal adverse effects associated with GLP-1 therapies.

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Closed and Collaborative: Mergers, acquisitions, and partnerships in June 2024

pharmaphorum

Explore the latest mergers, acquisitions, and partnerships in June 2024 involving LucidHealth, Syncona, Spur Therapeutics and more. Stay updated on the business collaborations shaping the industry.

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Fierce Pharma Asia—Merck's surprise hiccup in China; Leqembi's slow ramp; Lawmakers' new biosecurity target

Fierce Pharma

Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp. | Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp.

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AbbVie Completes $8.7 Billion Acquisition of Cerevel Therapeutics to Boost Neurological Pipeline

BioPharm

With this acquisition, AbbVie gains Cerevel’s clinical-stage assets that complement AbbVie's emerging neuroscience pipeline as well as branded products for treating psychiatric disorders, migraine, and Parkinson's disease.

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FDA approves innovative engineered cell therapy

European Pharmaceutical Review

For the first time in over a decade, there is a new treatment option for patients with synovial sarcoma, a rare soft tissue cancer. The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ® (afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease. Adaptimmune Therapeutics highlighted that TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy.

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What 'The Next Berlin Patient' and a PrEP’s 100% efficacy mean for HIV drug development

Fierce Pharma

This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS | This week on “The Top Line,” we dive into two studies in HIV research that were presented at the 25th International AIDS Conference in Germany.

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Artificial intelligence: The saviour of the pharmaceutical industry?

pharmaphorum

Discover how artificial intelligence is revolutionising the pharmaceutical industry and how it can potentially save time, resources, and lives. Learn more about the impact of AI on pharma and discussions at PING 2024.

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Otsuka Pharmaceutical to Purchase Jnana Therapeutics

Pharmaceutical Commerce

In deal that has the potential to reach $1.1 billion, Otsuka aims to grow its drug pipeline, specifically in the field of rare and autoimmune diseases.

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STAT+: Pharmalittle: We’re reading about a soft-tissue cancer drug approval, the Zepbound shortage ending, and more

STAT

Good morning, and happy Friday. This is Jonathan Wosen, West Coast biotech and life sciences reporter, filling in for Ed Silverman while he’s away from the Pharmalot campus. As you may know from my past entries, I’m no coffee drinker, but here are some newsy items to help wake you up and kick-start your weekend. … The FDA has approved a cutting-edge treatment for a rare soft tissue cancer, STAT tells us.

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Rejuvenate Biomed and SAS unveil AI tool to accelerate age-related drug development

Outsourcing Pharma

Rejuvenate Biomed and SAS have announced a creative partnership aimed at making big changes to drug discovery through the development of a user-friendly, AI-powered tool.

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