Fri.Nov 22, 2024

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Is Ozempic a controlled substance?

The Checkup by Singlecare

Ozempic (semaglutide) has made its way into headlines and water-cooler conversations largely due to its off-label use for weight loss more than its approved use for Type 2 diabetes mellitus. The glucagon-like peptide-1 (GLP-1) receptor agonist helps the pancreas release insulin and lowers blood sugar. It also mimics the GLP-1 hormone that tells your brain you’re full.

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STAT+: BridgeBio wins FDA approval for heart disease drug

STAT

The Food and Drug Administration approved on Friday a new medicine from BridgeBio for patients with a progressive heart disease — the first new treatment for the condition in over five years and the company’s first significant commercial product. The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby.

FDA
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Can you take Wegovy a day early?

The Checkup by Singlecare

Wegovy (semaglutide) is a once-a-week injection that’s approved by the Food and Drug Administration (FDA) to: Reduce excess body weight and maintain weight reduction in: Adults with a body mass index (BMI) of 30 or higher Adults with a BMI of 27 or higher who also have weight-related medical problems, such as high cholesterol or high blood pressure Adolescents ages 12–17 who are at or above the 95th percentile on sex- and age-specific growth charts Reduce the risk of major adverse cardiovascu

FDA
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STAT+: Sanofi plans to change payment terms for 340B hospitals

STAT

The battle over prescription drug discounts offered to hospitals under a federal program escalated as Sanofi became the third pharmaceutical company to disclose plans to change the way it will make payments. In a letter sent to hospitals and clinics on Friday, Sanofi indicated that certain hospitals covered by the 340B Drug Discount Program would receive credits for medicines ordered at full price from a wholesaler.

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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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As J&J tries to wrap up talc litigation in the US, the company now faces class action in UK

Fierce Pharma

While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the United States, its baby power problems are only just beginning in th | While Johnson & Johnson hopes to soon resolve more than 60,000 talc lawsuits with an $8 billion bankruptcy settlement in the United States, its baby power problems are only just beginning in the U.K.

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STAT+: What could Trump mean for the business of health? Scenarios for an RFK Jr. HHS

STAT

What happens when the Trump train hits the health care establishment? There’s no doubt that President-elect Trump’s decision to nominate Robert F. Kennedy Jr., an environmental activist and vaccine critic, as the secretary of the Department of Health and Human Services has thrown the health care sector into disarray.   This analysis is an attempt to imagine a future where Kennedy is running HHS, informed by interviews with current and former government officials, industry

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Skills Needed to Thrive in the Evolving Industry Landscape

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, comments on the specific technical and soft skills that are critical in order for pharma leaders and frontline employees to excel in ever-changing industry landscape, while explaining why these skills are beneficial when it comes to being proactive in handling talent shortages.

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H5N1 Bird Flu: A Slowly Looming Public Health Threat

Drug Topics

Public health and infectious disease experts offered their perspectives on the 2024 US bird flu outbreak and its potential of becoming a greater public health crisis.

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Will Walgreens’ store closures derail its clinical trial aims?

PharmaVoice

Despite a plan to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy juggernaut remains committed to drug research.

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No Association Between High-Dose NSAIDs, Hypertension in axSpA | ACR Convergence

Drug Topics

NSAIDS are typically the first line of treatment for axial spondyloarthritis.

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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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Pfizer led industrywide sales surge in Q3 after several quarters of dominance by Eli Lilly, Novo Nordisk

Fierce Pharma

After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue growth among the top companies in the biopharma industry, there was a new champion in the | After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue increases among the top companies in the biopharma industry, there was a new growth champion in the third quarter.

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Chain Pharmacist Embracing Expanded Role in the Profession

Drug Topics

On the most recent episode of Over the Counter, James Rider, PharmD, joined Drug Topics to discuss his career journey as a chain pharmacist.

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FDA Grants Orphan Drug Designation to RAG-21 for Treatment of ALS

Pharmacy Times

If approved, RAG-21 can offer improved outcomes in patients with amyotrophic lateral sclerosis (ALS), particularly those with aggressive subtypes.

FDA
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Disconnect Between Adolescent, Caregiver Pain and Depression Symptoms in Rheumatic Diseases | ACR Convergence

Drug Topics

PROMIS scores demonstrated the disparities between reported pain and mental health outcomes.

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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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As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact

Fierce Pharma

As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact fkansteiner Fri, 11/22/2024 - 09:04

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Reproductive Health Counseling and Education Crucial for Women With Rheumatic Disease | ACR Convergence

Drug Topics

Despite an interest in services, a majority of women do not have these critical conversations with their health care providers.

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FDA experts lukewarm on AZ's anticoagulant antidote Andexxa

pharmaphorum

AstraZeneca is facing some pushback as it tries to upgrade anticoagulant antidote drug Andexaa to full approval in the US.

FDA
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Nonopioid Options to Manage Chronic Pain in Veterans | ACR Convergence

Drug Topics

Chronic pain is more prevalent—and more severe—in veterans compared with the general US population.

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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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After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

Fierce Pharma

For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. Companies rarely want to make the shift back. | The pivot comes after the FDA issued a notice that the deficiencies in the company's approval bid for type 1 diabetes med Zynquista are too great to proceed for further discussion.

FDA
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Empowering community pharmacies: The key to bridging health inequalities

pharmaphorum

Community pharmacies play a crucial role in bridging health inequalities and empowering communities. Learn how the NHS and community pharmacies work together to improve health outcomes for all.

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Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

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Jazz gets first FDA nod for HER2 bispecific Ziihera

pharmaphorum

Jazz Pharma has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary tract cancer

FDA
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“No magic wand” for Novo Nordisk, as CagriSema pen supply rumours swirl

Pharmaceutical Technology

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

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Neuralink gets okay for its first international trial

pharmaphorum

Elon Musk's brain-computer interface (BCI) company Neuralink has been given the green light to test its device in tetraplegic patients in Canada

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Oseltamivir May Shorten Hospital Stays for Children With the Flu

Pharmacy Times

Children with obesity, asthma, and gastrointestinal disease had longer durations of stays compared with children without comorbidities.

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Enveda raises $130m to advance AI-driven plant based drug development

Pharmaceutical Technology

The biotech uses its AI platform to discover the therapeutic potential of plant-based molecules, advancing ten candidates with the funds.

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Arrowhead Pharmaceuticals Submits FDA Application for Plozasiran in Familial Chylomicronemia Syndrome

Pharmacy Times

Familial chylomicronemia syndrome (FCS) currently has no FDA-approved treatment and is associated with an increased risk of acute pancreatitis.

FDA
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Research digest: Assessing antibiotic appropriateness in hospital settings

Hospital Pharmacy Europe

A study aimed at quantifying excess antibiotic use in an acute UK hospital found that nearly a quarter of antibiotic days of therapy (DOTs) were unnecessary. The most significant opportunity to reduce antibiotic use came in optimising the pre-72 hours antibiotic review. Other important opportunities to reduce use included avoiding inappropriate initiation of antibiotics and ensuring course lengths were appropriate for each patient.

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FDA Grants Rare Pediatric Disease, Fast Track Designations to Gildeuretinol for Stargardt Disease Treatment

Pharmacy Times

As a rare and serious pediatric disorder, Stargardt disease can cause vision complications in patients.

FDA
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Zai Lab and Pfizer to commercialise XACDURO in China

Pharmaceutical Technology

Zai Lab and Pfizer have entered a strategic collaboration for the commercialisation of XACDURO in mainland China.

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Decision to Receive Pneumococcal Vaccine Among Older Adults Is Multi-Factorial, Influenced by Multidimensional Interventions

Pharmacy Times

Commonly cited factors influencing uptake of pneumococcal vaccination included knowledge of pneumococcal disease and vaccine benefits, recommendations from health authorities, and perceived risk of infection.

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Novartis acquires Kate Therapeutics to advance gene therapies

Pharmaceutical Technology

Novartis has announced the acquisition of Kate Therapeutics to enhance its portfolio of gene therapies for inherited neuromuscular diseases.

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Implementing CDC’s Core Elements of Sepsis

Pharmacy Times

The agency outlines key elements for building effective hospital sepsis programs.