Thu.Aug 08, 2024

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Problematic Opioid Prescribing Among Patients with Chronic Pain

Drug Topics

Researchers conducted a systematic review of literature exploring the misuse of opioid prescriptions for patients with chronic non-cancer pain.

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Market share shakeup: Big Pharma’s bestselling drugs drive industry shifts in 2024’s first half

PharmaVoice

The top drugs at each of the world’s most valuable pharma companies tell the story of just how much the industry has changed over the course of a few years.

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As FDA Decision on MDMA for PTSD Looms, What Would Approval Mean for Mental Health Treatment?

Drug Topics

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.

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Scientists are starting to uncover how neighborhood can affect the biology of cancer

STAT

Where you live has a relationship to your odds of getting cancer and surviving cancer. Epidemiologists studying this link they see in the data have focused on so-called social determinants of health — poor access to transportation, for example, could make it harder for residents to see a doctor. Places lacking grocery stores with fresh food could mean worse nutrition for locals.

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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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Extended Guselkumab Dosing Intervals to Treat Psoriasis

Drug Topics

Researchers addressed the difference between prescribing guselkumab doses every 16 weeks and every 8 weeks for super responder patients with moderate to severe psoriasis.

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FDA Grants Nalmefene Injection Approval for Emergency Treatment of Opioid Overdose

Pharmacy Times

The injection adds an additional option to address emergency known or suspected opioid overdoses.

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More Trending

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Bavarian Nordic scores $157M contract to replenish US supplies of smallpox/mpox vaccine Jynneos

Fierce Pharma

Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. | The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” Jynneos vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox.

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Making Lemonade Out of Lemons: A Win-Win for Patients and Pharmacies Dispensing GLP-1s

Drug Topics

With the high demand in GLP-1 medications, pharmacists are now living in an unprecedented time of filling prescriptions for high-cost brand-name drugs.

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ASTP/ONC proposal would require HHS contractors to use certified health IT tech

Fierce Healthcare

The Department of Health and Human Services’ technology office dropped a new proposed rule on Thursday that would require healthcare entities that contract with HHS to use government-cert | The newly rebranded Office of the Assistant Secretary of Technology Policy released a proposed rule Thursday that could expand the use of government-certified health technology.

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FDA Approves Nalmefene Injection for Opioid Overdose

Drug Topics

Nalmefene injection is an opioid receptor antagonist and comes in a single-dose, pre-filled auto-injector that delivers 1.5 mg of the medication per actuation.

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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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Big Health clinches FDA clearance of its digital therapeutic for insomnia, SleepioRx

Fierce Healthcare

Big Health, a maker of digital treatments for mental health, has clinched Food & Drug Administration (FDA) clearance of its product for insomnia, Fierce Healthcare has learned in an a | SleepioRx, its flagship digital therapeutic, is intended for the treatment of chronic insomnia and insomnia disorder as an adjunct to usual care in adults over 18.

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Isatuximab Shows Promise in Enhancing PFS for Patients with Multiple Myeloma

Pharmacy Times

Isatuximab (Sarclisa; Sanofi) in combination with standard-of-care significantly improved progression-free survival in patients with newly diagnosed multiple myeloma.

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STAT+: AI app claiming to diagnose STIs from penis pictures shut down after FTC scrutiny

STAT

The company that claimed its AI model could identify sexually transmitted infections from a single penis picture was shut down by the Federal Trade Commission in July. STAT wrote about the app, Calmara, and the immediate critical response it drew from patient advocates, doctors, and privacy experts in April. The founders did not adequately explain how they would protect minors from accessing the app and sensitive user information.

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RHB-104 Plus Standard of Care Offers Extended Treatment for Crohn Disease

Pharmacy Times

The primary end point of clinical remission at week 26 was met, with 36.7% of individuals treated with RHB-104 achieving clinical remission.

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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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Mayo Clinic taps startup SandboxAQ to study new tech — quantum sensing and AI — for cardiac diagnostics

Fierce Healthcare

Mayo Clinic is partnering with startup SandboxAQ to study a new medical device that uses quantum sensing technology and advanced AI algorithms for rapid diagnosis in cardiac care, such as potential | Mayo Clinic is partnering with startup SandboxAQ to study a new medical device that uses quantum sensing technology and advanced AI algorithms for rapid diagnosis in cardiac care, such as detecting a heart attack.

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Intravenous Immunoglobulin Shows Safety and Effectiveness as Treatment of Pyoderma Gangrenosum

Pharmacy Times

Intravenous Immunoglobulin as a therapy for patients with pyoderma gangrenosum could open new treatment avenues for the rare and challenging condition.

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Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

PharmaVoice

Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

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Tirzepatide Meets Both Primary End Points in Phase 3 SUMMIT Trial

Pharmacy Times

Tirzepatide demonstrates statistically significant improvements in adult patients who have heart failure with preserved ejection fraction and obesity.

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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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Many want employer benefits for substance, alcohol use issues—but few have them, survey finds

Fierce Healthcare

Though more than half of workers believe employer support for substance and alcohol issues is important, only 14% have access to such a benefit, a new survey finds. | The survey found that about a third of the workforce—or 60 million Americans—experience personal or family issues related to substance or alcohol use. This causes losses in productivity and increases in healthcare costs.

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Eli Lilly lifts sales guidance by $3B as supplies of Mounjaro and Zepbound recover

Fierce Pharma

While a glut of drugmakers have raised their 2024 financial guidance after the second quarter, those upgraded sales expectations pale in comparison to Eli Lilly’s new forecast for the year. | Lilly, which reported a 36% sales increase year-over-year to $11.3 billion in the second quarter, is raising its guidance for the full year by a staggering $3 billion.

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STAT+: AI drug developers Recursion, Exscientia to merge

STAT

Two of the leading companies in the AI drug development field, Recursion Pharmaceuticals and Exscientia, said Thursday that they will merge into one company. The new company will continue using the Recursion name and be led by Recursion co-founder and CEO Chris Gibson. Exscientia’s interim CEO, David Hallett, will serve as the company’s science chief.

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Citius notches first FDA approval, scoring with Lymphir for cutaneous T-cell lymphoma

Fierce Pharma

A year after it was hit with a rejection from the FDA, Citius Pharmaceuticals has scored an approval for Lymphir to treat cutaneous T-Cell Lymphoma.

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STAT+: Judge rules against Chamber of Commerce in Medicare drug negotiation lawsuit

STAT

WASHINGTON — A federal judge on Thursday tossed out a U.S. Chamber of Commerce lawsuit challenging Democrats’ drug pricing law. The decision is yet another loss for the pharmaceutical industry and its allies, which have filed lawsuits across the country arguing that the Inflation Reduction Act, which created a drug price negotiation program in Medicare , is unconstitutional.

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AI biotechs Exscientia and Recursion agree $688m merger

pharmaphorum

Recursion Pharma has agreed to merge with rival AI-powered drug discovery firm Exscientia in an all-stock deal valued at $688 million

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Watch: How drug patents pave the way to profit

STAT

This is Part 3 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. Discovering a new drug is a big win for a pharmaceutical company, but selling it for lots of money with no competition? The cherry on top. This kind of market exclusivity is only possible because of patents.

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Does Roche have buyer's remorse for Flatiron takeover?

pharmaphorum

Roche is said to be considering a sale of cancer data specialist Flatiron Health, just a few years after it bought the company for $1.

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How experiencing famine in the womb may shape people’s health as adults

STAT

Hunger killed an estimated 4 million people in Ukraine between 1932 and 1933 — the result of Holodomor, a famine inflicted by the Stalin-led Soviet regime. New research shows how the harm experienced during famines can extend even to people who haven’t yet been born. The study , published Thursday in Science, strengthens the link between fetal exposure to famine and increased risk for type 2 diabetes later on in life.

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Prospect Medical Holdings finds buyer for Crozer Health

Fierce Healthcare

Private equity firm Prospect Medical Holdings has entered into an agreement to sell off Crozer Health to CHA Partners. | Prospect Medical Holdings has entered into an agreement to sell off Crozer Health to CHA Partners.

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STAT+: Eli Lilly boosts 2024 revenue guidance by $3 billion on Mounjaro, Zepbound sales

STAT

Eli Lilly raised its full-year revenue guidance by $3 billion, driven by massive sales of its GLP-1-based diabetes and obesity drugs Mounjaro and Zepbound. The pharma giant on Thursday boosted its forecast for 2024 sales to a range of $45.4 billion to $46.6 billion from the previously guided range of $42.4 to $43.6 billion. It also raised its guidance for adjusted earnings per share to a range of $16.10 to $16.60 from the previously guided $13.50 to $14.00.

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Apellis, Sobi's 'enormous' Empaveli win could pressure Novartis in rare kidney diseases: analyst

Fierce Pharma

While Apellis Pharmaceuticals has spent much of the year working around setbacks that derailed the ongoing launch of its geographic atrophy (GA) drug Syfovre, a major phase 3 triumph could open up | Empaveli showed strong efficacy in two rare kidney diseases. The result “exceeded our already high expectations," an Apellis exec said, and it led analysts at Evercore ISI to assign the drug a majority future market share against Novartis’ rival.

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STAT+: Big Health gets FDA nod for its digital therapy for insomnia

STAT

Digital Therapeutics developer Big Health this week received Food and Drug Administration clearance for SleepioRx, a prescription treatment for insomnia. Big Health already sells a wellness version of the app, called Sleepio, to employers and health plans that make the product available to their members. The app delivers a specialized type of cognitive behavioral therapy for insomnia and the company boasts that it is backed by dozens of studies.

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CMS touts transparency and expediency in finalized transitional medical device coverage program

Fierce Healthcare

The Centers for Medicare and Medicaid Services released a final procedural notice on Wednesday to expedite Medicare coverage of novel medical devices and get the devices to Medicare benef | CMS released a final procedural notice on its TCET rule, which would expedite coverage for FDA Breakthrough medical devices. A bill is also making its way through Congress that would replace the rule.

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Sandoz lifts guidance after Humira biosimilar drives another quarter of sales growth

Fierce Pharma

After taking a market share lead in the crowded Humira biosimilar space and with other key launches in the works, Novartis spinout Sandoz is raising its full-year sales guidance. | The company touts leading biosimilar market share for its version of AbbVie's Humira.

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