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Medication Optimization Needed for Patients with Long COVID

Drug Topics

Investigators said there is an imperative to optimize medication utilization and explore the consequences of medication burden on treatment outcomes in patients with long COVID.

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STAT+: New details on a risky medical device show need for more FDA transparency, researchers say

STAT

Tonya Brand was horrified to find a piece of metal poking out of her inner thigh while relaxing at her house in Georgia in 2011. She had no idea what it could be.  It was only after extensive imaging that her doctors realized what had happened: A medical device that had been implanted in her two years earlier to catch blood clots had broken and was now migrating to different parts of her body.

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Opinion: The FDA’s risky action on compounding weight loss drugs

STAT

When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

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Smart ring maker Oura picks up $75M series D, inks strategic partnership with Dexcom

Fierce Healthcare

Oura is partnering with medical device maker Dexcom to integrate data from glucose biosensors with the Oura Ring, which tracks sleep, heart rate and activity. | Oura is partnering with medical device maker Dexcom to integrate data from glucose biosensors with the Oura Ring.

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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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FDA Grants Rare Pediatric Disease Designation for Treatment of Neonatal SP-B Deficiency

Pharmacy Times

The disorder presents as severe lung disease, with lung transplantation as the only current therapeutic option for long-term survival.

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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H5N1 bird flu virus in Canadian teenager displays mutations demonstrating virus’ risk

STAT

The genetic sequence of the H5N1 bird flu virus that infected a teenager in British Columbia shows that the virus had undergone mutational changes that would make it easier for that version of H5N1 to infect people, scientists who have studied the data say.  There’s currently no evidence the teenager, who remains in critical condition in hospital, infected anyone else.

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Primary care player Forward shutters after raising $400M, rolling out CarePods

Fierce Healthcare

Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday. | Primary care player Forward is abruptly shutting down its operations, closing its locations and canceling scheduled visits, the company publicly announced Wednesday.

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AHA 2024: Tirzepatide Lowers Risk of Worsening Heart Failure, CVD Death in Adults With Obesity

Pharmacy Times

This is the first trial that tested the effect of any medication on major heart failure outcomes in patients with HFpEF and obesity, according to investigators.

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Despite fears over RFK Jr. pick, industry should focus more on FDA job: analyst

Fierce Pharma

Robert F. | In a contrarian take offered by BMO Capital Markets' Evan Seigerman, the analyst said Robert F. Kennedy Jr. may not rock the boat as much as feared for the biopharma industry.

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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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Q&A: Common Reasons Independent Pharmacies Face PBM Audits

Drug Topics

A conversation with Trent Thiede, PharmD, MBA, president of PAAS National, at NCPA 2024.

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Opinion: RFK Jr. says he isn’t an anti-vaxxer. He’s wrong

STAT

If he can make it past the Senate, Robert F. Kennedy Jr. will be the next secretary of Health and Human Services. Since the position was created, each secretary has had significant experience in public health, health care administration, or related government work. None has listed “spreading vaccine misinformation” as their primary health care experience.

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FDA advisory committee to roll up sleeves on generative AI

Fierce Healthcare

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. | The FDA seeks advice on regulatory challenges it has identified for generative AI used in medical devices, which include uncertainty about the foundation model, hallucinations and the ability to define intended use.

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AHA 2024: GLP-1, SGLT2 Treatments May Lower Risk of Future Heart Attack, Stroke for Stroke Survivors

Pharmacy Times

The 2024 American Heart Association and American Stroke Association stroke prevention guidelines recommend glucagon-like peptide-1 receptor agonists to reduce the risk of stroke in individuals with diabetes and high cardiovascular risk.

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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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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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Community Pharmacists Crucial in RSV Vaccine Education Efforts

Drug Topics

After shared decision making with their community pharmacist, patients were more likely to receive an RSV vaccine.

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The many legal fronts of RFK Jr.’s fight against vaccines

STAT

Robert F. Kennedy Jr. took leave as chairman of Children’s Health Defense, a nonprofit known for spreading doubt about vaccines, to run for president last year. But he is still fighting in court alongside the group, putting him in an unusual position for someone nominated as Secretary of Health and Human Services.   If confirmed by the Senate, Kennedy will have power to guide the agencies he oversees toward his priorities.

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Amazon One Medical rolls out telehealth treatment services in competition with Ro, Hims & Hers

Fierce Healthcare

Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men's hair loss and anti-aging skin care. | Amazon One Medical is rolling out a new service to provide Prime members access to clinical treatments for common health and lifestyle conditions like men's hair loss and anti-aging skin care.

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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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FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label

Pharmacy Times

The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.

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England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo

Fierce Pharma

Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.

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COVID-19 Significantly Impacted Health Services for Patients with Pancreatic Cancer

Drug Topics

Researchers analyzed the impact of the COVID-19 pandemic on outcomes for patients with pancreatic cancer living in England.

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Opinion: New guidance endangers the rights of people with disabilities

STAT

Nothing brought Olivia more joy than when her daughter and grandchild visited her group home in Brooklyn in the early 2000s. Each hug and shared laugh lit up her face with pride like any mother’s, grounded in love, family, and connection. Olivia’s story should not be remarkable, but history almost denied her the chance to experience her family.

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Grifols linked to €7bn takeover offer from Brookfield

pharmaphorum

Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).

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What Will Happen if Millions of Americans Lose Access to GLP-1s at the Same Time?

Pharmacy Times

There has never been such widespread and popularized use of compounded products due to shortages. Will consumers rise up with pitchforks if the party is shut down?

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Rapid growth spurt for UCB's Bimzelx continues with hidradenitis suppurativa nod marking 5th FDA approval

Fierce Pharma

It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. | The latest nod positions Bimzelx to go head-to-head with Novartis' Cosentyx in the hidradenitis suppurativa market.

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J&J sues HRSA for blocking controversial 340B rebate plan

Fierce Healthcare

Johnson & Johnson is escalating its fight with the federal government over its controversial plan to change how it doles out drug discounts to hospitals. | Johnson & Johnson is escalating its fight with the federal government over its controversial plan to change how it doles out drug discounts to hospitals. J&J is suing the Health Resources and Services Administration for blocking the implementation of its new 340B rebate model.

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First U.S. case of new mpox strain detected in California

STAT

California has detected the country’s first case of a new mpox strain that is spreading from person to person. The infected individual had recently traveled from Eastern Africa, where multiple countries are battling transmission of this virus. The individual was treated in a health facility in San Mateo County and is in isolation at home, the California Department of Public Health announced in a statement released Saturday.

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MSD joins PD-1/VEGF push in cancer with LaNova deal

pharmaphorum

There has been a lot of talk about drugs targeting both PD-1 and VEGF stealing the crown held by MSD's Keytruda in cancer immunotherapy. Now, the company has made a move to try to make sure it isn't left behind. Its solution is a licensing deal with Chinese biotech LaNova Medicines for LM-299, which consists of an anti-VEGF antibody joined to the functional parts of a pair of anti-PD-1 antibodies.

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Insights on Innovation: Craig Beavers Previews AHA 2024 and Emerging Trends in Cardiovascular Care

Pharmacy Times

Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, CACP will be moderating a session about social determinants of health and heart failure.

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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Providers, payers focused on initial 'quick wins' for AI with plans to grow investment: survey

Fierce Healthcare

More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds. | More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.

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Opinion: FDA commissioner: We need action and higher-quality research on ultra-processed foods

STAT

As the saying goes, you are what you eat. And, unfortunately, the food we eat is only solidifying America’s tragic title: We have the lowest life expectancy among large high-income countries. The U.S. Food and Drug Administration is taking a number of steps to help people in the U.S. build healthy diets — including with respect to ultra-processed foods — and the food industry and research community should, too.

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Syndax gets FDA okay for first-in-class leukaemia drug

pharmaphorum

Shortly after a disappointing trial readout for Syndax's menin inhibitor Revuforj in one form of leukaemia, the company has claimed FDA approval in another

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