Thu.Aug 01, 2024

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FDA Warns Against Using At-Home Chemical Peels, Cites Retailers

Drug Topics

Pharmacists should be knowledgeable about the symptoms of chemical peel irritation to effectively advise patients.

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Behind the malaria vaccines: A 40-year quest against one of humanity’s biggest killers

STAT

Malaria is one of our most ancient foes — and one of the wiliest. Caused by parasites that certain mosquitoes spread through their bites, malaria overwhelms us, establishing an infection before we can put up a fight. It can go on to destroy red blood cells, batter organs, and even damage the brain.

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Trending Sources

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FDA to Weigh Bayer’s Treatment for Hot Flashes Associated with Menopause

Drug Topics

In 3 Phase 3 trials, elinzanetant reduced the frequency and severity of moderate to severe vasomotor symptoms, and improved sleep disturbances.

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STAT+: Eli Lilly’s obesity drug Zepbound shows benefits in heart failure patients

STAT

Eli Lilly’s obesity drug Zepbound cut the risk of complications and improved symptoms in patients with a common type of heart failure, making it the second GLP-1 drug to show positive results in the disease area after Novo Nordisk’s Wegovy. The Phase 3 trial studied patients who had heart failure with preserved ejection fraction (or HFpEF) and obesity.

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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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Expert: Tau Oligomers Are a Culprit in the Spread of Alzheimer Disease Pathology

Pharmacy Times

Tara Spires-Jones, DPhil, FMedSci, discusses how oligomeric tau clumps inside brain synapses, pointing to indirect evidence that it may be progressing through the brain by jumping between connections.

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Morning Rounds: Inside the making of the first malaria vaccine

STAT

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. Okay, I know it’s unoriginal to express awe at the speed at which time passes, but like … how is it already August? Okay, instead I will recall Louise Glück’s “ Matins.” (“You want to know how I spend my time?

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More Trending

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STAT+: Jim Wilson, gene therapy pioneer, departs Penn to set up new companies

STAT

Jim Wilson, a leading gene therapy researcher who has persisted through the field’s ups and downs , is leaving his longtime academic home at the University of Pennsylvania to found two new companies. Penn is spinning out much of the work of its Gene Therapy Program, where Wilson had served as director, to the two new companies. Most of the program’s employees will be offered roles at the new companies, according to a statement released Wednesday night.

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Changing Faces: May and June 2024 supplier and digital hires

pharmaphorum

Changing Faces announces new supplier and digital hires for May and June 2024, including AxoSim, ERS Genomics, Newcells Biotech, SHINE Technologies and more. Stay updated with the latest industry developments.

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STAT+: With new data, Regenxbio advances plan for Duchenne gene therapy

STAT

Regenxbio said Thursday that its experimental gene therapy for Duchenne muscular dystrophy was administered to two more boys and produced high levels of a miniaturized version of the protein needed for muscles to function properly. The updated results from an early study suggest the Regenxbio therapy, called RGX-202, could become the second genetic medicine for Duchenne to reach the market, following the Food and Drug Administration’s approval of Sarepta Therapeutics’ Elevidys in J

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Changing Faces – Pharma and biotech May and June 2024

pharmaphorum

Stay updated on the latest hiring news and developments from Pfizer, Lilly, Gilead, Epsilogen, and other pharma and biotech companies in May and June 2024 with Changing Faces.

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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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4 takeaways from STAT’s story on the development of malaria vaccines

STAT

For the first time, the world is starting to roll out malaria vaccines to children in sub-Saharan Africa. The story of the development of those vaccines, a decades-long effort that stretched from labs in New York, England, and Belgium to clinical research sites in a number of African countries, is detailed in a STAT special report  published Thursday.

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Another IRA lawsuit bites the dust with ruling on Novo Nordisk case; company pledges to appeal

Fierce Pharma

Like clockwork, another lawsuit challenging the constitutionality of the Inflation Reduction Act's (IRA's) price-setting measures has been shot down in the courts. | The ruling from the New Jersey federal court marks the latest in a string of rejections as various drugmakers have taken to the courts to fight the drug pricing legislation.

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STAT+: Private equity firms to acquire health care billing and payments firm R1 in $8.9 billion deal

STAT

R1 RCM is finally getting taken off the public markets, ending a months-long saga between private equity firms that were trying to take control of the large health care billing and collections company. Private equity firms TowerBrook Capital Partners and Clayton, Dubilier & Rice are teaming up to buy R1 , the companies said Thursday. TowerBrook, in a partnership with the Catholic hospital system Ascension, already owns 36% of R1 — which made TowerBrook and Ascension the company’

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Going beyond the hype: Embracing AI for strategic advantage

pharmaphorum

Discover how AI is revolutionising the medical and pharmaceutical industries. Learn how to leverage AI for strategic advantage and stay ahead of the competition in this insightful article.

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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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venBio raises $528 million for its fifth fund

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. We’ve got another busy day of earnings and new data readouts. Let’s get straight into it.

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Bilateral Mastectomy Lowers Risk of Contralateral Breast Cancer But Not Mortality

Pharmacy Times

The findings provide guidance for clinicians and patients when navigating therapeutic options to establish treatment plans.

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Listen: The long journey to make malaria vaccines, and Sarepta’s ties with patient advocates

STAT

Why has it taken so long for the world to get malaria vaccines? What relationship should drug companies have with patient advocates? And who in biotech is having a brat summer? We discuss all that and more in this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. Andrew Joseph, our Europe correspondent, joins us to talk about his special report on the 40-year quest to develop the world’s first malaria vaccines.

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Bateman Horne Center leads the way in ME/CFS and long COVID education

Outsourcing Pharma

The Bateman Horne Center of Excellence (BHC) has established itself as a trusted leader in the clinical care, provider education, patient advocacy, and research of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID.

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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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South Africa's HIV Research: Unlocking the mysteries of elite controllers

pharmaphorum

South Africa occupies a pivotal position in the global battle against HIV. As of 2022, it is home to around 7.8 million individuals living with HIV, representing the largest HIV burden in the world. However, it is this very challenge that has placed South Africa at the leading edge of innovative HIV research, with potential ramifications for the millions affected by the disease globally - and that starts with elite controllers.

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Alignment Healthcare raises full-year guidance after favorable star rating recalculations

Fierce Healthcare

Plan membership at Alignment Healthcare is again higher than previously expected, the company announced ahead of its second-quarter earnings call. | Alignment Healthcare says it is on pace for full-year adjusted EBITDA guidance and increasing its membership outlook after its second-quarter earnings call.

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Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in Asia

Fierce Pharma

Like many other biopharma companies, Kyowa Kirin is in restructuring mode. | Kyowa Kirin is planning “a significant reduction” in its small molecule drug discovery research activities and will trim certain manufacturing roles. The company is also divesting its Chinese operations as part of a larger restructuring in the Asia-Pacific region.

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OneBlood hit with ransomware attack, state of donors' data unknown

Fierce Healthcare

OneBlood, a non-profit blood donation organization serving hospitals in the southeastern U.S., was hit by a ransomware attack on Wednesday that has impacted its operations. | OneBlood, a non-profit blood donation center servicing the southeastern United States, was attacked by cybercriminals on Wednesday.

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Opinion: PBMs aren’t opening access to lower-cost biosimilars. Reform is needed now

STAT

The Federal Trade Commission presents on Thursday  its interim staff report , “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.” It reveals how pharmacy benefit managers intentionally force people onto high-cost, high-rebate drugs. This report comes on the heels of Congress also  putting pressure on PBMs during a hearing that highlighted how these companies undermine patient health and increase drug costs.

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Bipartisan Policy Center urges Congress to extend Medicare hospital at home, telehealth policies by end of year

Fierce Healthcare

The Bipartisan Policy Center released a report on Wednesday that recommends that C | The Bipartisan Policy Center released a report on Wednesday that recommends Congress extend the Medicare Acute Hospital Care at Home waiver for five years to increase uptake.

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After series of patent lawsuits, Novartis doubles down in Entresto defense with FDA complaint

Fierce Pharma

Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.” | Novartis has filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories.

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Chronic, New Onset Anxiety Associated with Risk of Dementia

Drug Topics

Researchers aimed to address the association of all-cause dementia risk and 3 separate chronicities of anxiety.

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Five Ways Cancer Care Teams Can Best Utilize the Expertise of Pharmacists

Pharmacy Times

Pharmacists' roles in community-based cancer centers are expanding, with a more significant role in managing complex treatment regimens, ensuring comprehensive patient care, navigating drug shortages, and collaborating with multidisciplinary teams to enhance patient outcomes and streamline health care operations.

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How long does it take valacyclovir to work?

The Checkup by Singlecare

Valacyclovir, sold under the brand name Valtrex, is an antiviral drug. It’s an L-valine ester of acyclovir and belongs to a class of drugs called purine nucleoside analogs. The U.S. Food and Drug Administration ( FDA ) has approved it to treat and prevent herpes simplex virus (genital and cold sores) and varicella-zoster virus, which can cause chickenpox and shingles.

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Valneva, LimmaTech ally on quest for first Shigella vaccine

pharmaphorum

Valneva has bolstered its vaccines pipeline with a shot designed to protect against shigellosis – a major global health threat – licensed from LimmaTech Biologics.The French pharma company – best known for its COVID-19 jab and recent approval for the world's first chikungunya vaccine Ixchiq – is paying €10 million upfront for a stake in LimmaTech's S4V vaccine candidate, and promising undisclosed regulatory, development and sales-based milestone payments.

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STAT+: Pharmalittle: We’re watching positive Zepbound cardiovascular data, a move to take 23andMe private, and more

STAT

Greetings from London, with STAT reporter Andrew Joseph here filling in for Ed for the day. We’ve shifted to our afternoon version of a cup of stimulation (a nice glass of iced tea — it is summer after all), which is tasting extra delicious given that we just read a Wall Street Journal story on the Olympic triathlon that featured this review on the Seine swim: “It didn’t taste great.

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Regeneron touts launch of Eylea HD—and warns of manufacturing issue with linvoseltamab

Fierce Pharma

With U.S. sales of $304 million during the second quarter, Regeneron’s high-dose version of Eylea came up just short of analyst projections. | The launch of Regeneron's Eylea HD has helped the Eylea franchise to a rebound after U.S. sales had declined in each of the previous three quarters. Additionally, Regeneron reported that its FDA decision date on its application for approval of multiple myeloma therapy linvoseltamab is likely to be delayed because of a manufacturing issue.

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FDA Expands Approval of Dostarlimab-Gxly Plus Chemotherapy to All Adults With Primary, Recurrent Endometrial Cancer

Pharmacy Times

The RUBY trial will continue and analyze the overall population survival after treatment with the drug combination.

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STAT+: On Andrew Left and the government’s fraud case

STAT

I love the Summer Olympics. Every four years I transform into a huge fan of gymnastics and swimming, probably like all of you. But I also find myself obsessed with some of the nichier sports — handball, rowing, fencing! Go USA! As a reporter who spends most of his time at the intersection of biotech and Wall Street, I know Andrew Left, the short seller indicted by the government on fraud changes.

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