Thu.Nov 21, 2024

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Understanding endotoxin cartridge testing: frequently asked questions

European Pharmaceutical Review

Can cartridges be used as a standard method for assessing endotoxins across various sample types throughout the industry? A : FDA-licensed cartridges utilise the kinetic chromogenic method and are fit to test any type of endotoxin sample including, but not limited to, waters, raw materials, in-process samples, final products, medical devices and radiopharmaceuticals.

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After youth vaping surge, the U.K. moves to ban disposable e-cigarettes

STAT

LONDON — The stacks of brightly colored disposable e-cigarettes, touting flavors like cotton candy ice and greengrape melon and often looming over the not-dissimilar-looking candy displays, have become a commonplace sight in convenience stores in both the U.S. and the U.K.  But here, they’re on their way out.

FDA
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European Pharmaceutical Review Issue 5 2024

European Pharmaceutical Review

Articles in Issue 5 of European Pharmaceutical Review include: FOREWORD ICH Q6(R1): test criteria and specifications Dave Elder David P Elder Consultancy CELL & GENE THERAPY How automation and digital technologies will unlock the full potential of advanced therapies Dr Stephen Ward CGT Catapult Hydrogel encapsulation: unlocking the potential of cell therapies for targeted treatments Dr Stephen Harrington and Francis Karanu Likarda SUSTAINABILITY Transitioning to digital product information t

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Which NP Specialty is Right For Me?

Board Vitals - Pharmacist

Before applying to NP school, one of the most important questions that you should answer for yourself is “What type of nurse practitioner do I want to become?” While many of us have experience working in a certain setting (ICU, clinic, emergency room, general pediatric floor, etc.) or with a certain population (babies, children, women, older adults, etc.), that does not mean that we automatically have a specialty in mind when considering becoming a nurse practitioner.

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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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Easing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?

European Pharmaceutical Review

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults. With the recent failure of Lykos’ trial, how do you see the future of psychedelic therapies in research, especially in treating disorders like depression, PTSD, and substance use diso

FDA
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STAT+: Novartis buys gene therapy startup Kate Therapeutics, joining pursuit of muscular dystrophy treatment

STAT

Novartis said Thursday it purchased gene therapy startup Kate Therapeutics for up to $1.1 billion in upfront payments and milestones.  It’s a rare buyout for a field that has quieted over the last couple years, amid a wider biotech downturn and questions about both the effectiveness and profitability of these one-time treatments.  With the deal, Novartis will acquire a pipeline of preclinical gene therapies for three different genetic neuromuscular diseases, along with the under

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Amgen and Pfizer appoint new Science executives

European Pharmaceutical Review

Several new appointments were announced by Amgen and Pfizer yesterday, focusing on R&D functions. Pfizer Inc. is appointing Dr Chris Boshoff , PhD, as Chief Scientific Officer and President, Research & Development. Dr Boshoff will begin this new role on 1 January 2025 and will oversee all R&D functions across every therapeutic area in the company.

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Tai Chi Intervention, Liver Disease Prevalence for People with OA | ACR Convergence

Drug Topics

Researchers explored the benefits of tai chi and prevalence of liver disease in patients with osteoarthritis.

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Guide to Outsourcing 2024

European Pharmaceutical Review

Nowadays it is not uncommon to see “help wanted” signs in storefront windows. The current labour shortage has impacted many quality control (QC) microbiology labs, just like any other industry, which results in overworked and unsatisfied employees. However, outsourcing microbial identification is a tried-and-true method to save time by placing attention on other high value tasks, while simultaneously relieving overworked employees, leading to increased retention.

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Despite Benefits, Mediterranean Diet Adherence in RA Remains Low | ACR Convergence

Drug Topics

The Mediterranean diet is largely considered one of the healthiest diets.

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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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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals

PharmaVoice

A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.

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Outcomes Vary When Cannabis Is Used for Pain Management in Rheumatic Disease | ACR Convergence

Drug Topics

Investigators evaluated the role that cannabis plays in pain management in different populations with rheumatic diseases.

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Clinical Safety Data Show Switching Between Rituximab Biosimilars Does Not Increase Adverse Events

Pharmacy Times

There were 2 main types of switches, including switching to rituximab subcutaneous and switching among different intravenous rituximab treatments.

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PMDD More Prevalent in RA, Leading to Worsened Mental Health | ACR Convergence

Drug Topics

Premenstrual Dysphoric Disorder is considered a psychiatric disorder and is associated with moderate to severe physical, affective, and behavioral symptoms.

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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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Public Health Matters: Pharmacists as Frontline Health Providers: Collaborating for Better Patient Outcomes

Pharmacy Times

In this episode of Public Health Matters, Christina Madison discusses pharmacist-physician collaborations with Amina Abubakar and Stephen Lewis.

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Sotagliflozin’s Effect on BP Remains in T2D Regardless of Kidney Function | AHA 2024

Drug Topics

Research presented at American Heart Association’s 2024 Scientific Sessions examined the SGLT inhibitor’s effect on systolic blood pressure.

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Antibody Drug Conjugate Targeting CLDN1 Receives FDA Fast Track Designation

Pharmacy Times

ALE.P02 could provide further treatment options for advanced or metastatic anti–claudin-1+ squamous cancers.

FDA
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Examining Impact of COVID-19 Diagnosis Timing on AF Progression | AHA 2024

Drug Topics

“[O]ur data do not support the hypothesis that early COVID resulted in more significant structural or electrical cardiac remodeling that would increase the likelihood of atrial fibrillation progression,” the authors said.

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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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Usage of AI With PET/CT Images Could Detect Impacts of Immunotherapy in Lung Cancer

Pharmacy Times

The risk of developing interstitial lung disease after immunotherapy was 6.5 times higher in individuals with high inflammation.

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Q&A: Chain Pharmacist Shares Keys to Success in Retail Settings

Drug Topics

James Rider, PharmD, shared reflections on his experiences as a pharmacy manager at CVS.

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FDA Accepts sNDA for Darolutamide With ADT for Patients With mHSPC

Pharmacy Times

The supplemental new drug application (sNDA) is based on results from a phase 3 trial that enrolled patients with metastatic hormone-sensitive prostate cancer (mHSPC).

FDA
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Expiration of hospital-at-home, telehealth policies threatens nonprofit hospitals' recovery: Fitch

Fierce Healthcare

Not-for-profit hospital and health systems are slowly recovering from their worst year financially in 2022. | If federal lawmakers don't act to extend the Acute Hospital Care at Home program, which expires at the end of this year, it could dampen not-for-profit hospitals' nascent financial recovery, according to a new report from Fitch Ratings.

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Intravenous Injections of Zanidatamab-Hrii Receives FDA Accelerated Approval for IHC+ BTC

Pharmacy Times

The indication is for adults with previously treated unresectable or metastatic HER2+ (IHC+) biliary tract cancer (BTC) as detected by an FDA-approved test.

FDA
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Roche's Vabysmo shows potential to treat eye disorder common in Asia

Fierce Pharma

Few pharmaceutical products have taken the market by storm like Roche’s Vabysmo. | Interim results from a late-stage trial of Roche's Vabysmo on Asian patients with polypoidal choroidal vasculopathy suggest that the injected treatment is effective. After 16 weeks, patients showed vision improvement which was equivalent to reading roughly one and a half more lines on an eye chart.

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Higher Composite Dietary Antioxidant Index Reduces Risk of Diabetes for Women

Pharmacy Times

Investigators also established a negative association with higher vitamin C intake and diabetes prevalence.

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Sweeping nonprofit House bill passes, healthcare groups turn attention to Senate

Fierce Healthcare

Legislation that gives a president wide-reaching power to financially harm any nonprofit an administration deems as terrorist supporting passed out of the House of Representatives Nov. 21. | H.R. 9495 passed in the House on Thursday. If signed into law, a president would be able to take a nonprofit's tax-exempt status away without due process, critics say.

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Novel IVIG Formulation KIG10 Is Effective, Well Tolerated in Adults With Primary Immunodeficiency

Pharmacy Times

No acute serious bacterial infections were observed in a trial of patients with the debilitating immune disorder, a strong mark of safety and tolerability.

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Versant enters obesity with new startup

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hullo! Today, some squiddy drug delivery, a leukemia deal between Kura Oncology and Kyowa Kiri, and a new GLP-1 startup from Versant Ventures.

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Rusfertide Reduces Phlebotomy Need, Improves Symptom Control in Polycythemia Vera

Pharmacy Times

Rusfertide may sustain hematocrit levels in patients with polycythemia vera.

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Pfizer, under pressure to change, names oncology head as new R&D chief

PharmaVoice

Chris Boshoff will replace Mikael Dolsten, who’s stepping down after 15 years leading research at the drugmaker.

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Advancing Compounding Standards: Insights From the USP Compounding Implementation Workshop

Pharmacy Times

The workshop addressed trends, initiatives, and regulations for quality compounding.

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From promise to reality: Unlocking the true business potential of genomic medicine

pharmaphorum

Explore how investing in genomic medicine can unlock the true business potential in the manufacturing and therapeutic areas. Understand the promise and reality of this cutting-edge field.

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Mass General Brigham primary care docs petition to unionize, citing burnout and lacking resources

Fierce Healthcare

Nearly 300 primary care doctors at Mass General Brigham (MGB) have petitioned to unionize. | The group, if approved, would join the Doctors Council, an affiliate of the Service Employees International Union representing attending physicians nationwide.