Thu.Sep 29, 2022

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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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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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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.

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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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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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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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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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More Trending

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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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Woman of the Week: Pepper Bio’s Samantha Dale Strasser

PharmaVoice

The co-founder of Pepper Bio entered the biotech world three years ago with the goal of transforming drug discovery through the emerging discipline of transomics.

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Glargine May Be Effective Addition to Metformin in Maintaining Target Glycated Hemoglobin Levels for Type 2 Diabetes

Pharmacy Times

New research suggests patients with type 2 diabetes who have elevated glycated hemoglobin levels, even when on metformin, could benefit by adding glucose-lowering glargine.

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Early analysis suggests monkeypox vaccine is reducing risk of infection in U.S.

STAT

A very preliminary analysis of data from 32 states appears to suggest that the monkeypox vaccine being used in the United States is reducing the risk of infection among vaccinated people, Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said Wednesday. Walensky said the analysis showed that people who were eligible to be vaccinated against monkeypox because of their personal level of risk but who had not received the vaccine were 14 times more likely to contract

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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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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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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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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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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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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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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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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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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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People on the move … Sept. 29

Drug Store News

Important personnel changes you should know this week.

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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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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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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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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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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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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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Amazon invests nearly $1B to expand pay, benefits for front-line employees

Drug Store News

​​​​​​​Pay increases for front-line employees begin in October, with average starting pay now more than $19 per hour.

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Virtual Event: When the Barrier to a Breakthrough Drug Is You Can’t Make It

STAT

Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET. Despite all of their promise, newer medicines, especially those based on advanced technologies, have been met with unprecedented challenges in scaling up manufacturing, quality control, and commercial launch.

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Rite Aid reports loss in fiscal 2023 Q2

Drug Store News

The retailer’s revenues for Q2 were $5.9 billion, compared with prior year revenues of $6.1 billion.

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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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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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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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Patient Engagement is no longer optional

pharmaphorum

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. Shifting operations to meet this new way of working may seem challenging, but it doesn’t have to be, as very often there is an existing ground in pharmaceutical and biotech companies to align advocacy and engagement in medicines development and access, says Red Thred S

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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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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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STAT+: Pharmalittle: Biogen Alzheimer’s drug slowed cognitive decline in a trial; European pharma warns energy costs may halt some generic production

STAT

Good morning, everyone, and how are you today? We are doing just fine, thank you, after a brief respite to observe ancient rituals. Now, though, we have returned to the usual routine of online meetings, calls, and deadlines. Some things are predictable, yes? So to cope, we are enjoying a cup of stimulation — chocolate raspberry is our flavor du jour — and we invite you to join us.

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