Thu.Sep 29, 2022

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FDA Fast Tracks Treatment for for Select Stage IIB to IV Malignant Melanoma

Pharmacy Times

KIN-2787 is a potential treatment for BRAF class II or III alteration-positive and/or NRAS mutation-positive, metastatic or unresectable, stage IIB to IV malignant melanoma.

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Ebola experimental vaccine trial may begin soon in Uganda

STAT

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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Trending Sources

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Challenges with Current Treatments and Emerging Treatments for C. difficile Infection (CDI)

Pharmacy Times

Drs Chopra and Feuerstadt summarize challenges with current treatments and discuss live biotherapeutic products that are being studied for recurrent C difficile infection (rCDI).

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Efficacy and Safety of Ranibizumab and Lucentis for Wet AMD Compared

Drug Topics

The authors noted that the proportion of patients losing fewer than 15 letters from the baseline BCVA score in the study eye was comparable between the two groups.

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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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FDA Approves Bevacizumab Biosimilar for Six Types of Cancer

Pharmacy Times

Bevacizumab-adcd (Vegzelma) is indicated for the treatment of nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic colorectal cancer; persistent, recurrent, or metastatic cervical cancer; metastatic renal cell carcinoma; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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Increased Menstrual Cycle Length Tied to COVID-19 Vaccine

Drug Topics

In a recent study, participants who had received a COVID-19 vaccine saw an average increase in menstrual cycle length of less than 1 day.

More Trending

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Biogen, Eisai say lecanemab has aced phase 3 Alzheimer’s study

pharmaphorum

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the

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Tip of the Week: Routine Opioid Outcome Monitoring in Community Pharmacy Presents Opportunities

Pharmacy Times

With a simple intervention, pharmacists came off as compassionate and caring while their efficacy in treating patients improved.

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The Effects of Psychedelics in Healthy Participants

Drug Topics

In a well-blinded study, researchers investigated and directly compared the acute effects of LSD and psilocybin in healthy participants.

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Study: Multivitamin Mineral Supplements Have Potential to Improve Cognition

Pharmacy Times

In a study of 2262 individuals, investigators also found that cocoa extract had no effect on cognition.

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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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Is TEE the key for novel antibiotics?

European Pharmaceutical Review

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

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Foundational Trials for Fecal Microbiota Transplantation for C. difficile Infection

Pharmacy Times

Dr Lodise summarizes foundational trials that led to the use of fecal microbiota transplant for the treatment of rCDI.

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STAT+: Burning questions left unanswered about the latest Alzheimer’s therapy

STAT

News of the first clearly successful clinical trial for a new Alzheimer’s disease treatment in two decades has brought hope, scrutiny, and skepticism to a field accustomed to disappointment. Whether that treatment is a meaningful advance or another false dawn depends on scientific details yet to be presented and corporate decisions still to be made.

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Continuous Glucose Monitors Offer Substantial Glucose Improvements in Patients with Poorly Controlled Diabetes

Pharmacy Times

Continuous glucose monitors eliminate the need for frequent fingerstick use and carrying blood glucose monitoring supplies.

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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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An Alzheimer’s therapy scores winning results, but what could it mean for patients?

STAT

The news Tuesday night that a clinical trial of an experimental Alzheimer’s therapy had succeeded hit like a blast — at last, a rare win in a disease devastating nearly 6 million Americans and countless more caregivers. The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo.

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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S.

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Opinion: Rabies will continue to take lives without stronger human-animal health policies

STAT

The Covid-19 pandemic set back many of the global health goals for 2030. One of the most feasible to recover is the target of eliminating human deaths from rabies , thanks to an effective, inexpensive vaccine for dogs. Yet this ambition, backed by the United Nations , is in jeopardy because public health budgets for controlling the disease are often directed toward treatment for people exposed to it, even though the greatest public health risk comes from infected dogs.

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Researchers Explore Approaches to Block T-Cell Exhaustion

Pharmacy Times

Expert discusses whether epigenetic programs regulate human T cell exhaustion and whether epigenetic-based strategies can be used to enhance T cell-based therapies.

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FDA proposes new rules for which foods can be called ‘healthy’

STAT

The Food and Drug Administration wants to update its rules for which foods can be branded “healthy.” The proposed label rule aims, in part, to address a question as old as medicine: What does it mean for a food to be healthy? It would update the “healthy” label guidelines from 1994 to match up-to-date nutrition research — a notoriously messy and heavily debated field.

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Recalls Due to Nitrosamine & Legal Action Being Taken

Digital Pharmacist

Over the past few years, the FDA has recalled many popular drugs due to a contaminant, Nitrosamine, being found in them. Medications that have been found to include concerning amounts of nitrosamines include losartan and other ARB’s, Metformin, ranitidine, rifampin, and Chantix. Let’s talk a bit more about these recalls and what nitrosamines exactly are, what to do if a patient inquires about this recall, and the legal actions that are being taken.

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Her mother’s abortion was required under China’s one-child policy. Her own would be illegal under Tennessee’s post-Roe ban

STAT

This is part of a series of snapshots from post-Roe America. I t started as a joke. Jen was early in her first pregnancy, sitting with her husband after lunch. You know those gimmicky websites, he was saying, where you can name a star after someone and the person gets a certificate in the mail? What if, instead, we named our child after the biggest planet in the solar system?

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AAM report: Generics, biosimilars generated $373B savings in 2021

Drug Store News

The Association for Accessible Medicines has released its 2022 U.S. Generic & Biosimilar Medicines Savings report highlighting the value of generic and biosimilar medicines.

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A bionic pancreas aims to take the math out of managing type 1 diabetes

STAT

For people living with type 1 diabetes, it pays to be good at math. Keeping blood glucose in a healthy range requires a constant stream of calculations: counting the carbs in each meal, and then finding the right dose of insulin to balance them out. But new clinical trial results from an automated insulin delivery system from Beta Bionics suggest that computation can be reliably outsourced to a machine — potentially putting better blood glucose control in the hands of more patients.

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Patient-centered services is one way to improve health outcomes

Drug Store News

Nicholas Turos, vice president of business development at Babson Diagnostics, discusses making blood testing more convenient and accessible.

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Opinion: How health systems can truly value Black lives: help close the racial wealth gap

STAT

Institutional declarations of support for Black lives were ubiquitous in the aftermath of the murder of George Floyd. The radical, transformative change demanded by hundreds of thousands of protestors across the country, however, has not been realized. Health systems can and must help move the country in that direction. Addressing immediate social needs, such as food insecurity, housing, or access to health care, as some health systems are now doing, is important.

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Targeted Therapies Could Be Key to Treating Myelodysplastic Syndrome

Pharmacy Times

IDH inhibitors show encouraging results in patients with myelodysplastic syndrome, but longer follow ups are needed in a larger patient population to confirm the results.

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Virtual drug screening identifies possible new antidepressants in LSD-like molecules

STAT

What’s a hallucinogen without the hallucinations? Perhaps a potent and fast-acting antidepressant, according to a new study based on virtual drug screening. Psychedelic drugs are now widely understood to have striking antidepressant effects , so a group of computational biologists sought to determine whether any new, LSD-adjacent molecules might have other medicinal powers.

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Tom’s of Maine intros 1st incubator initiative

Drug Store News

Tom’s of Maine launched its first-ever incubator initiative to help propel the next generation of BIPOC leaders driving environmental solutions.

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STAT+: If a new Alzheimer’s drug works, was there any point to the Aduhelm controversy? Yes

STAT

The announcement Tuesday night from Eisai and Biogen that their experimental medicine, lecanemab, reduced Alzheimer’s patients’ decline as measured by a clinical questionnaire is one of the biggest — and potentially happiest — shocks in the recent history of medicine. It’s a shock because Biogen had so bungled the launch of their previous Alzheimer’s drug, Aduhelm, with failed clinical trials, a tortuous path to approval , and a wholesale rejection by Me

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Daratumumab Resistance in Multiple Myeloma May Be Associated With High Levels of NHE6 Expression

Pharmacy Times

Two Houston Methodist cancer researchers were granted a quarter of a million dollars each to study some of the most lethal cancers.

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STAT+: Lilly is accused by the federal government of discriminating against older sales reps

STAT

In an unusual move, the U.S. Equal Employment Opportunity Commission has filed a lawsuit accusing Eli Lilly of age discrimination in hiring its sales representatives around the country. The federal agency contended that a Lilly human resources executive made a presentation in April 2017 that indicated the company’s national workforce was “skewed toward the older generations” and had 20% fewer millennials than the American workforce, overall, which was seen as a problem that

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme. 1 One of the recommendations in a report by the FDA’s Drug Shortage Task Force called for the implementation of such a ratings system that would provide pharmaceutical buyers greater

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STAT+: A ‘disaster’, or a ‘clear path’ forward?: New FDA guidance on AI in medicine sparks strong reactions

STAT

New guidance from the Food and Drug Administration is triggering strong reaction from researchers and regulatory experts, who see it as an attempt to significantly expand the oversight of software tools used to guide clinical decisions. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.

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Making Connections: Dr. Alexander Jarasch

Pharmaceutical Commerce

Former head of data management and knowledge management at Germany’s National Center for Diabetes Research, Dr. Alexander Jarasch outlines his ideas around the future of AI and data management in the pharma and healthcare space.

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