Sat.Aug 19, 2023 - Fri.Aug 25, 2023

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Elevating Pharmacy Technicians: Remote Work Can Enhance Prescription Duties

Pharmacy Times

By embracing collaboration, optimizing work hours, and prioritizing patient care, pharmacy technicians are leading the charge towards an inclusive, technologically advanced, and patient-focused era in pharmaceutical practice.

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FDA Delays Drug Supply Chain Security Act Deadline Until November 2024

Drug Topics

The new deadline to be in compliance with the requirements will be November 27, 2024.

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U.S. health officials lay out plans to cope with respiratory virus season

STAT

With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different. In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention and the Food and Drug Administration detailed the various countermeasures available to combat Covid-19, RSV, and influenza, and discussed the expected timing on the rollout

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Bright Energy Wellness launches CBD-infused powdered drink mixes

Drug Store News

The powdered drink mixes—available in Lemonade and Berry Medley flavors—are infused with 25 mg of 100% CBD per serving.

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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 Clears Investigational New Drug Application to Treat Amyotrophic Lateral Sclerosis

Pharmacy Times

The drug can now be tested for safety, tolerability, and efficacy in a phase 1 study.

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Pharmacy Staffing Shortages Lead to Disruptions in Patient Care

Drug Topics

A 2022 survey conducted by the National Community Pharmacists Association reported that more than 70% of pharmacies were struggling to fill staff positions.

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Pharmaceutical migration study sampling procedure reported

European Pharmaceutical Review

A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.

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Study: Some Health Care Professionals Found to Spread COVID-19 Misinformation Via Social Media

Pharmacy Times

Investigators determined that there needs to be an evaluation of harm caused by pharmacy professionals who are in unique positions on social media, propagating misinformation about COVID-19, vaccines, treatment, masks, and other conspiracy theories.

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Moderna, Novavax Update Vaccines as COVID-19 Variants Cause Rise in Cases

Drug Topics

The CDC and WHO are currently tracking several variants that are driving the majority of new cases around the world.

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Another Keytruda-Lenvima ambition is dashed as Merck, Eisai end head and neck cancer trial

Fierce Pharma

Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. | Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. The companies have decided to shut down a phase 3 study testing the PD-1/TKI combo in first-line head and neck cancer.

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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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Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision? According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments.

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Study: New Digital Tobacco Cessation Program Leads to 44% Quit Rate of Smoking Compared to Control Program

Pharmacy Times

The digital cessation platform is the first FDA-cleared OTC device to help individuals quit smoking tobacco.

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Rise of Third-Party Pharmacy Audits

Drug Topics

A greater number of pharmacy audits are originating not only from third party payors, but also from various government agencies, such as Medicare and Medicaid.

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AstraZeneca scores its second paediatric approval for Soliris in Japan

Pharmaceutical Technology

Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.

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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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Chutes & Ladders—CEOs on the move at Cano Health, Ascertain and more

Fierce Healthcare

Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry.

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Scientists Identify New Cause for Inherited Neurodegenerative Diseases

Pharmacy Times

The recent discovery could aid further research on the cause of Huntington’s disease and other inherited conditions.

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Mid-Year Updates on PBM Legislation

Drug Topics

The Modernizing and Ensuring PBM Accountability Act, recently passed by the Senate Finance Committee, aims to regulate PBMs in the Medicare Part D, Medicare Advance, and Medicaid spaces.

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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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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An effort to diversify genetic research finds new variant for Parkinson’s disease in African populations

STAT

A group of Nigerian, British, and U.S. doctors have discovered a genetic variant that increases the risk of Parkinson’s disease in people of African and mixed-African descent and is not seen in those with European ancestry, a finding that could improve treatment of the movement disorder in a vastly underserved population. “It could be a major mechanistic basis of Parkinson’s disease in African populations,” the researchers said in their paper , published this week in

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Expert: Pharmacists Should Be Using a Holistic Approach for Women’s Health

Pharmacy Times

There is lots of information about matters of women's health online, both true and untrue, but pharmacists remain a credible source for educating women about health matters.

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COVID-19 Booster During Pregnancy Increases Antibodies in Mother, Infant

Drug Topics

Receiving the vaccine during pregnancy is cited as crucial for both confronting disproportionate infant vulnerability and easing the disease burden for new and expecting mothers.

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FDA grants first approval for multiple sclerosis biosimilar

European Pharmaceutical Review

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Tyruko (natalizumab-sztn) is a biosimilar to Tysabri (natalizumab) injection for adults with relapsing forms of MS. Approval of Tyruko has been granted to Sandoz Inc. It is indicated for the following relapsing forms of MS: Clinically isolated syndrome – a single, first occurrence of MS symptoms Relapsing-remitting disease – in this type of MS, episodes of new neurological symptom

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On a roll, Novo's star obesity drug Wegovy shows benefits in patients with heart failure

Fierce Pharma

Just a few short weeks after Wegovy posted a major cardio outcomes win, Novo Nordisk has chalked up another heart-related victory for its semaglutide star. | In a phase 3 study, semaglutide at the 2.4 mg dose bested placebo at reducing symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction. The drug also led to greater improvements in exercise function and more weight loss versus a dummy drug, according to study results published in The New

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FDA Approves First Biosimilar of Natalizumab for the Treatment of Relapsing Multiple Sclerosis

Pharmacy Times

The FDA is the first regulatory agency globally to approve natalizumab-sztn as a biosimilar for natalizumab.

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Majority of Infants in ICU for RSV Have No Underlying Health Conditions

Drug Topics

A recent study found that Infants younger than 3 months, those born prematurely, and those who were publicly insured were at a higher risk for intubation.

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

The FDA Law Blog

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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10 benefits of acidophilus probiotics

The Checkup by Singlecare

Maybe you’ve heard that acidophilus is excellent for your gut health. Or perhaps a friend has recommended it as an immunity booster for fighting the cold or flu. The truth is that acidophilus—a beneficial bacteria found in your body, certain foods, and most probiotic supplements —has many health benefits. L. acidophilus probiotics can help your body in several ways, including aiding in weight loss, reducing cholesterol levels, and helping to treat vaginal infections.

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Vaccine Candidate Shows Promise for Slowing Cognitive Decline in Mild Alzheimer Disease

Pharmacy Times

UB-311 has shown to be well-tolerated with a durable antibody response in a previous phase 1 trial, and new results from a phase 2a study support its continued development.

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ChatGPT Often Provides Inaccurate Cancer Treatment Recommendations

Drug Topics

A new study found that 34% of the chatbot’s answers included 1 or more recommendation that did not align with clinical guidelines.

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Cabometyx study ends early after researchers see 'dramatic' benefits in neuroendocrine tumors, Exelixis says

Fierce Pharma

It's not always a good thing when a drug developer stops a cancer trial. But in a recent case for Exelixis, a Cabometyx trial ended early because of an undeniable efficacy showing. | Exelixis' drug proved its worth in treating advanced pancreatic and extra-pancreatic neuroendocrine tumors, so much so that an independent board unanimously recommended an early stop.

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Birch bark extract recommended by NICE for epidermolysis bullosa-induced wounds

Hospital Pharmacy Europe

A birch bark extract has been recommended by NICE for treating skin wounds associated with dystrophic and junctional epidermolysis bullosa. In the UK, draft guidance from NICE has recommended a birch bark extract within its marketing authorisation, as an option for treating partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in people aged 6 months and over.

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FDA Approves Remdesivir to Treat COVID-19 in Patients with Hepatic Impairment

Pharmacy Times

The drug is the first approved antiviral COVID-19 treatment that could be used across all stages of liver disease.

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FDA Approves Pfizer RSV Vaccine for Use During Pregnancy to Protect Infants

Drug Topics

The respiratory syncytial virus vaccine (Abrysvo) is the first and only maternal RSV vaccine used to help protect infants from the virus.

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