Tue.Jun 11, 2024

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FDA, DOJ Launch Multi-Agency Task Force to Address Illegal E-Cigarettes

Drug Topics

The new task force highlights a stronger government focus on curbing the risks of e-cigarettes for young people, especially after sustained calls for stricter action on the public health issue by lawmakers and the public.

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Four Tops singer’s lawsuit says he visited ER for chest pain, ended up in straightjacket

STAT

When Alexander Morris, a member of the Motown group The Four Tops , visited a Detroit-area Ascension hospital with chest pain and trouble breathing, he said the staff assumed he was mentally ill after he told them he was a famous singer. Instead of treating Morris, a white security guard told him to “sit his Black ass down” and he was placed in a straightjacket, Morris claims in a new lawsuit.

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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.

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Opinion: Empathy should guide responses to reported vaccine injuries

STAT

As a co-leader of the team at the National Institutes of Health that developed technologies powering a number of Covid-19 vaccines, I often speak publicly about vaccine science, even though I no longer work for the government. After my talks, people often approach me, almost always thanking me for my work. There is no denying the millions of lives that Covid-19 vaccines saved. sometimes, though, they relate stories of vaccine injuries.

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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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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.

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Melinda French Gates, going solo, aims to influence reproductive rights in the U.S.

STAT

Last week, Melinda French Gates officially left the Bill & Melinda Gates Foundation with a $12.5 billion check from Bill Gates, per the terms of their separation. Her departure from the foundation she co-founded in 2000 had been announced in May , and on Friday she published a parting memo thanking all who worked with her during her tenure at the foundation.

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STAT+: Biotech co-founded by entrepreneur Bob Langer is testing a new approach to developing obesity treatments

STAT

A new company founded by a group of biotech veterans, including Bob Langer , came out of stealth mode Tuesday with plans to create pills for everything from obesity to rare diseases. The company, Syntis Bio, is based on a technology developed by Langer and MIT professor Giovanni Traverso that can coat the stomach and potentially other organ surfaces, changing the way that drugs are absorbed or, in the case of obesity, which hormones are triggered.

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Clear expands footprint in healthcare with InterSystems, Epic partnerships

Fierce Healthcare

Clear, a company well recognized for its biometric identity tech used in airports, is expanding its reach in healthcare and ramping up partnerships with major health IT companies like InterSystems | Clear, a company well recognized for its biometric identity tech used in airports, is expanding its reach in healthcare and ramping up partnerships with major health IT companies like InterSystems and Epic.

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Opinion: Blood tests for cancer detection aren’t yet ready for prime time

STAT

Multi-cancer early detection tests (MCEDs), sometimes called liquid biopsy tests , are a new method of detecting cancer early. While the concept is promising, these untested tests currently pose significant problems. MCEDs look for circulating DNA or cells from cancers. The goal is to detect cancer in its earliest stages in people without any signs or symptoms of the disease.

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Balancing Trust and Technology: The Role of AI in Patient-Pharmacist Interactions

Pharmacy Times

At ASHP Pharmacy Futures 2024, Casey Olsen, PharmD, explains that AI can affect patient trust in providers, with implications for the importance of learning to balance use of technology with human elements in clinical settings.

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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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STAT+: Google’s Verily to offer GLP-1 drugs through Lightpath, its retooled chronic care app

STAT

For the second time in as many years, Google’s health tech spinout Verily is pivoting. The company announced Tuesday that it will phase out its chronic disease management app Onduo over the next year and a half as it transitions to a new, “evolved” product called Lightpath. Lightpath Metabolic, expected to be available in 2026, will not only include programs for people with type 1 and type 2 diabetes and hypertension — as the current iteration of Onduo does — b

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3rd to 7th June – This week in clinical trials

pharmaphorum

Get the latest updates on clinical trials from 3rd to 7th June involving companies like uniQure, Takeda, Otsuka, CatalYm, Agios, and Transgene. Stay informed on the latest developments in the field.

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Bernie Sanders calls vote to subpoena Novo Nordisk U.S. head over Ozempic, Wegovy prices

STAT

WASHINGTON — Senate health committee chair Bernie Sanders has called a vote to subpoena the chief of Novo Nordisk’s U.S. division over the company’s pricing of the popular diabetes drug Ozempic and the obesity drug Wegovy, his office announced Tuesday. The vote is scheduled for June 18. Sanders (I-Vt.) is seeking the appearance of Novo’s Doug Langa at a hearing next month.

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AHIP 2024: The hurdles to widespread biosimilar adoption

Fierce Healthcare

LAS VEGAS—Biosimilars hold significant promise in reducing pharmacy costs, and pharmacy benefit managers have touted them for years as being the key to introducing competition to some of the most i | LAS VEGAS—Biosimilars hold significant promise in reducing pharmacy costs, and pharmacy benefit managers have touted them for years as being the key to introducing competition to some of the most in-demand branded products.

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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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STAT+: Tweezers? Wrenches? Researchers plot prosthetics’ future with tools, not hands

STAT

Nearly half of people with upper-limb prosthetics abandon them. They’re often uncomfortable, dysfunctional or just don’t feel like a part of someone’s body. But in a recent study in iScience , researchers made an unusual choice. They used virtual reality to try out bionic tools like tweezers or wrenches as hand prosthetics. The participants felt as or even more embodied with these tools compared with a “natural” hand.

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Humana finds value-based care leads to fewer hospital admissions for kidney patients

Fierce Healthcare

Value-based care arrangements significantly reduce costs and improve outcomes for people with chronic kidney disease and end-stage renal disease, according to a report from Humana. | A new report from Humana shows value-based care lowers medical expenses and is coupled with fewer inpatient utilization for its members needing kidney care.

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FDA Approves Sarilumab for Active Polyarticular Juvenile Idiopathic Arthritis

Pharmacy Times

Polyarticular juvenile idiopathic arthritis is a form of arthritis that affects multiple joints at one time.

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New polymer-based drug delivery system developed for tuberculosis

European Pharmaceutical Review

Researchers have reported the successful formulation of clofazimine spray-dried poly (lactic acid-co-glycolic acid) (PLGA) microparticles as an “efficient” treatment for tuberculosis (TB). In treating this bacterial infection, the paper highlighted that oral therapy often fails to achieve therapeutic concentrations at the primary infection site, the lungs.

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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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OSF HealthCare President Sister Diane Marie McGrew dies at 57

Fierce Healthcare

Sister Diane Marie McGrew, president of the OSF HealthCare, died on Sunday. | McGrew had served as president of the 16-hospital Franciscan health system since 2006, and also held longstanding roles on its various boards. No plans for her succession have been disclosed.

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FDA says it’s getting serious about illegal vapes. It’s still likely to get a tongue lashing.

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. BIOSECURE might hitch a ride with a key defense bill Here at STAT we’ve not reported much on the annual National Defense Authorization Act, so it was surprising to learn that more than 1,300 amendments have been submitted to that bill for a House Rules Committee h

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Gilead forks over $40M to settle thousands of claims in web of litigation over alleged delay of safer HIV meds

Fierce Pharma

As Gilead Sciences awaits the progression of California state litigation over its alleged delay of safer HIV drugs, the company is biding its time with a proposed $40 million settlement t | More than 2,000 plaintiffs accused the HIV drugmaker of purposely waiting to launch safer TAF-based meds in the early 2000s in order to maximize profits from its older TDF-based products.

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FDA wants to make the home a healthcare hub

pharmaphorum

The FDA is exploring ways to transform the home into a healthcare hub, bringing healthcare services closer to individuals. This article discusses the potential impact of this trend on the future of healthcare.

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Wheel launches AI products for telehealth providers

Fierce Healthcare

Telehealth technology platform Wheel launched its new, AI-powered solution called Horizon on Wednesday. | Virtual care technology vendor Wheel launches a new AI product to drive insights from patient data and reduce burden on providers.

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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

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AHIP 2024: Oshi Health now available in all 50 states

Fierce Healthcare

Virtual gastrointestinal care clinic Oshi Health will be available nationwide by September 2024. | Oshi Health will soon be the only virtual gastrointestinal center of excellence available nationwide.

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Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone

pharmaphorum

The FDA's Single Institutional Review Board (sIRB) mandate is good news for clinical research. Learn more about how this mandate benefits everyone involved in the clinical research process.

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Ipsen, Genfit gain FDA approval for Iqirvo in liver disorder, teeing up Intercept showdown

Fierce Pharma

Once hyped as a potential blockbuster medicine for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s elafibranor has found its calling as a treatment for a lower-profile liver disorde | Once hyped as a potential blockbuster medicine for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s elafibranor has found its calling as a treatment for a lower-profile liver disorder.

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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

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Using CGM to Evaluate Hyperglycemia in Patients with Early Stage Breast Cancer

Drug Topics

In a study presented at ASCO 2024, investigators found that all 20 included patients with early stage breast cancer receiving chemotherapy developed hyperglycemia.

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EU orders bird flu vaccine supplies from CSL Seqirus

pharmaphorum

CSL Seqirus will provide 665,000 doses of bird flu vaccine to the European Commission to protect at-risk workers and guard against a potential outbreak

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NeuroFlow acquires measurement-based care platform Owl to expand behavioral health offerings

Fierce Healthcare

NeuroFlow, a behavioral health tech company, has acquired Owl, a measurement-based care tech startup. | Owl works with outpatient behavioral health providers like certified behavioral health clinics or addiction treatment centers, while NeuroFlow works with primary care and payers.

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Purity, potency, and safety – affordably – in stem cell therapy

pharmaphorum

In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh discusses stem cell therapy, and accessibility to and affordability of such treatment, with Rafael R Carazo Salas, founder and CEO of CellVoyant, an AI-first biotechnology company spun out from the University of Bristol.

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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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