Fri.Jun 16, 2023

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Biopharmaceutical science powered by PRIDE

PhRMA

This June marks Lesbian, Gay, Bisexual, Transgender and Queer (LGBTQ+) Pride Month. At PhRMA, we’re proud to celebrate the diversity and inclusion of our LGBTQ+ colleagues and the patients our companies aim to help. As an industry driven by science, we believe diversity in the lab drives greater collaboration, scientific advancement and groundbreaking medicines impacting the lives of patients.

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Management of Clostridoides Difficile: A Focus on the Pharmacist's Role in the Care Continuum

Pharmacy Times

Patient education and counseling play a critical role in preventing C. difficile recurrence, and pharmacists are uniquely positioned to provide treatment recommendations, educate patients and health care providers, optimize transitions of care, and reduce the risk of recurrent CDI.

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Trending Sources

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New data: America is an API powerhouse

PhRMA

Policymakers and the media have been taking a close look at the medical supply chain recently, including the manufacturing locations of active pharmaceutical ingredients (APIs) for medicines used by Americans. APIs are what make a medicine a medicine — they are the substance in the medicine that treats or cures a disease or affects a condition within the body.

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Have Children Truly Ever Been ‘Therapeutic Orphans?’

Pharmacy Times

Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.

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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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Merck's Keytruda aims for updated stomach cancer label with positive data

Fierce Pharma

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study. | After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors.

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Expert: Immunotherapies, Targeted Therapies Show Promise in Melanoma

Pharmacy Times

Heidi Finnes, PharmD, BCOP, FHOPA, director of clinical ambulatory pharmacy practice at Mayo Clinic, discussed updates in melanoma and the use of immunotherapies and targeted therapies.

More Trending

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FDA Committee Recommends Development of Monovalent, XBB-Containing Vaccines

Drug Topics

The VRBPAC committee voted 21-0 in favor of this recommendation.

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FDA Approves Supplemental New Drug Application To Expand Mavacamten Label for Obstructive Hypertrophic Cardiomyopathy

Pharmacy Times

VALOR HCM is the second study to show that mavacamten can significantly reduce symptoms of obstructive hypertrophic cardiomyopathy, which includes left ventricular outflow tract.

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Game on, AbbVie. Roche's Columvi nabs FDA nod as 2nd bispecific for large B-cell lymphoma

Fierce Pharma

Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma. | Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label.

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AmerisourceBergen Corporate Partnerships Team Aims to Support, Guide Pharmacy Customers

Pharmacy Times

Claire Biermaas, president of Corporate Partnerships at AmerisourceBergen, discussed the Corporate Partnerships Team, which works closely with pharmacy customers to guide their processes and help execute their vision.

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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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Stanford Medicine launches initiative to advance responsible AI in healthcare

Fierce Healthcare

With the release of ChatGPT, what had long been science fiction became a reality, leaving healthcare wondering where medicine meets machine. | This week, Stanford Medicine and Stanford Institute for Human-Centered Artificial Intelligence (HAI) launched Responsible AI for Safe and Equitable Health (RAISE-Health) with the goal of addressing critical ethical and safety issues regarding the technology.

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FDA Grants Accelerated Approval to Glofitamab-gxbm for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Pharmacy Times

Glofitamab targets CD3, a protein found on the surface of immune T cells in patients with relapsed or refractory diffuse large B-cell lymphoma, and CD20, a healthy or malignant protein that lines the surfaces of B cells.

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Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab

STAT

Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured an unusual sentiment: optimism inflected with worry. Optimism because, after years of failed studies and the disastrous accelerated approval of aducanumab, we’re enjoying a less than one-year-old streak of good news. The latest bright flash is the June 9 Food and Drug Administration hearing on the anti-amyloid antibody lecanemab (to be sold by Eisai as Leqembi).

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New Therapies Show Significant Efficacy in Breast Cancer

Pharmacy Times

Both immunotherapies and targeted therapies are showing significant promise in these areas, offering patients new treatment options.

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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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Prevention Strategies Critical for Child Safety During Summer

Drug Topics

Melody L. Berg, PharmD, MPH, BCPS, editorial director, American Society of Health-System Pharmacists, explains best practices, treatments, and preventive measures for sunburn, bug bites, and waterborne infections.

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Educate Patients About Hand Sanitizers

Pharmacy Times

Health care professionals can provide patients with tips on appropriate hand sanitizer use, as well as product recommendations.

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Automation platform Luma Health launches digital call deflection to save providers, patients time

Fierce Healthcare

Luma Health, a platform automating the patient journey, has launched a new digital call deflection service to reduce inbound call volume for provider staff. | Calls are redirected to self-service text messaging, which the company argues helps short-staffed providers get patients to the next step in their care quickly.

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Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

Over the past few years, my mission to help people recover from Hashimoto’s has become increasingly focused on using food as medicine (or food pharmacology) to address many of the root causes and symptoms of thyroid conditions. In addition to incorporating healing foods into my diet, I’ve also discovered many herbs and spices that can have profound benefits for healing.

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FDA advisory committee recommends a monovalent COVID booster

Fierce Pharma

Hello again to a monovalent COVID-19 vaccine. Goodbye to the bivalent shot. | Hello again to a monovalent COVID-19 vaccine. Goodbye to the bivalent shot. That was the message Thursday from an FDA advisory committee, which decided unanimously that COVID vaccines this fall should not provide coverage against the original, wild-type coronavirus and that protection only is needed against an XBB strain.

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Tapinarof Cream 1% Shows Positive Topline Results for Treatment of Pediatric Atopic Dermatitis

Drug Topics

According to Dermavant, tapinarof cream 1% is a novel, aryl hydrocarbon receptor agonist in development as a once-daily topical cream.

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Opinion: The DNA from dog tumors may hold the secret to better human cancer drugs

STAT

This year, nearly 6 million dogs in the U.S. will receive a cancer diagnosis. That’s approximately three times greater than the number of Americans who will be diagnosed with cancer this year, even though humans are estimated to outnumber pet dogs by nearly 4 to 1. Yet the genetic similarities between human and dog cancers may point the way to treatments that can save lives on both ends of the leash.

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Ibuprofen Injection Approved by FDA to Treat Fever, Pain in Infants

Drug Topics

The expanded labeling allows for an intravenously delivered formulation of ibuprofen (Caldolor) in infants aged 3 to 6 months.

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Nurses Experience Needlestick Injuries With Evenity Syringe Needle

Pharmacy Times

Errors risk transmission of blood-borne pathogens, including HBV, HCV, HIV, to health care providers, patients.

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Testosterone supplementation not linked to heart attacks in study, reversing earlier finding

STAT

Testosterone supplementation in men with low levels of the hormone did not increase the risk of heart attacks in a 5,246-patient study, allaying fears that were raised more than a decade ago in a smaller trial, researchers said Friday. Although the results ease a significant safety concern about testosterone-containing gels and patches, the researchers running the study emphasized it does not address the more widespread use of such products in men who have normal levels of testosterone but who h

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Here's what hospitals need to know about MedPAC, MACPAC's latest payment recommendations to Congress

Fierce Healthcare

A pair of key panels advising Congress on Medicare and Medicaid policy recommended lawmakers adopt contentious site-neutral payment for certain ambulatory services and amend the Social Security Act | The congressional advisory panels backed site-neutral payments for certain ambulatory services and called for amendments to secure uncompensated care payments during economic downturns.

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Getting rid of bias in clinical calculators isn’t as simple as taking race out of the equation

STAT

Racial bias is everywhere in medicine, including the calculators doctors commonly use to predict a patient’s risk of disease and inform their treatment. A growing movement is encouraging medical specialties and hospitals to reconsider the use of race in those tools. But a new study shows that removing bias isn’t as simple as taking race out of the equation.

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Exchanging Mantra’s for M.A.P.S.

ISPE

Exchanging Mantra’s for M.A.P.S. Trudy Patterson Fri, 06/16/2023 - 16:37 iSpeak Blog iSpeak Exchanging Mantra’s for M.A.P.S. Edyna Miguez 16 June 2023 ISPE’s Women in Pharma ® Hosts a Self Defense and Kickboxing Class at the 2023 ISPE Annual Meeting & Expo. In the spirit of celebrating strength, the Women in Pharma ® International Steering Committee decided to change things up for the 2023 ISPE Annual Meeting & Expo , and in lieu of the annual Tuesday Morning Yoga session, Women in Pharma ® is p

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Can you drink coffee with Plavix?

The Checkup by Singlecare

Heart disease is the leading killer of Americans in the U.S. A common antiplatelet medication known as Plavix ( clopidogrel bisulfate ) is commonly prescribed to people with heart disease to prevent blood clots and lower the risk of having a heart attack or stroke. In fact, Plavix is often prescribed after a heart attack or stroke or a stent is inserted, or if you have narrowing of the peripheral arteries, poor circulation, or recurring chest pain.

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STAT+: Pharmalittle: FDA cites another troubled plant at company contributing to cancer drug shortages; USDA to push food producers over antibiotic claims

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we plan to manicure the grounds, promenade with the official mascots and check in on the Pharmalot ancestors. And if time permits, there may be another listening party, where the rotation may include this , this, this, and this.

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Biosimilar Infliximab Not Shown to Cause Adverse Outcomes in Patients With IBD

Drug Topics

Hesitation from patients and providers to switch to an infliximab biosimilar may not be necessary, new study finds.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Pharmacists’ Involvement in Treatment Decisions for NSCLC Has Increased and Evolved

Pharmacy Times

A plethora of targeted therapies, biomarker-driven therapies, and immunotherapies are now available.

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STAT+: Trade group scolds drugmaker for ‘unethical’ attempt to gain info about rival product

STAT

In a notable move, a U.K. trade group has rebuked Leo Pharma for a “serious and extremely concerning” violation of voluntary codes after learning a company manager coerced staff into gaining competitive information. And by doing so, the drugmaker discredited and lowered confidence in the pharmaceutical industry. The incident involved an attempt by a Leo manager to gain pricing information about a rival medicine from an unnamed individual who, at the time, worked for the U.K.

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How can AI be best harnessed for pharmacovigilance data?

European Pharmaceutical Review

According to a recent review funded by GSK Biologicals, artificial intelligence (AI) and machine learning (ML) seems intuitively, to be well suited to perform pharmacovigilance (PV) tasks given the large volume of data, high degree of uncertainty and need to learn from data. However, the paper highlighted the challenges these technologies hold for analytics.