Tue.Jan 09, 2024

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How Pharmacists Can Successfully Navigate the FDA’s New DSCSA Stabilization Policy

Drug Topics

In August, the FDA issued a 1-year stabilization policy on the final enhanced drug distribution security requirements under the DSCSA. What exactly does that mean for pharmacists?

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Real-World Experience With Continuous Glucose Monitoring Is an “Eye-Opening” Experience

Pharmacy Times

Most important of all, we gained a new level of empathy and understanding for patients diagnosed with diabetes whose diagnosis requires that they are constantly mindful and attentive to the balance of diet, exercise, and lifestyle in their day-to-day lives.

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Trending Sources

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STAT+: Doudna institute hatches plan to ‘cure hundreds of diseases’ left behind by CRISPR revolution

STAT

Researchers attending gene therapy meetings over the past couple years were liable to bump into a svelte, graying scientist explaining in emphatic, Russian-inflected English that the U.S. was wasting the grand potential of CRISPR gene editing. Fyodor Urnov, the scientist in question, estimates he gave the talk 30 to 40 times: to fellow researchers, pharma executives, Food and Drug Administration officials, congressional staff, journalists, patient advocates.

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FDA Approves Berdazimer Topical Gel as First Treatment for Molluscum Contagiosum

Pharmacy Times

Berdazimer topical gel, 10.3% (Zelsuvmi; Ligand Pharmaceuticals Inc) has been approved for the treatment of molluscum contagiosum in individuals aged 1 year and older.

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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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The Afghan father aided U.S. soldiers. Now Texas Medicaid won’t pay for his son’s gene therapy

STAT

On a sweltering day in August 2021, as the engines of a hulking C-17 cargo plane drowned out pops of gunfire and Taliban rocket explosions around them, the young Afghan couple looked down at their 4-month-old son, Mohammad, and felt a shuddering wave of relief. But as the plane lifted above the dusty peaks that hug Kabul like a fortress of sandstone and schist, that feeling grew heavy with grief — for the parents and siblings they were leaving behind, and for Afghanistan, the only home th

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JPM24: Pfizer CEO promises 'year of execution' after recent struggles, Seagen buyout

Fierce Pharma

Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. | Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches.

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How Co-Pay Accumulators, Maximizers Disrupt Patient Access to Care

Drug Topics

In this conversation from the Healthcare Advocate Summit, Ned Woody, senior associate director of field reimbursement at Daiichi Sankyo Inc. - Oncology, discusses the disruptive impact that these programs have on patients.

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STAT+: FDA’s Peter Marks seems inclined to grant full approval to Sarepta’s Duchenne gene therapy

STAT

SAN FRANCISCO — Peter Marks, the Food and Drug Administration’s top regulator of gene therapies, seems very comfortable with granting some form of full approval to Elevidys, the Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy, based on his comments to me on Monday night during our “fireside chat” at a STAT event.

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Opportunities Abound to Take Back Your Pharmacy

Drug Topics

Tyler Woods, PharmD, was joined by Ajay Mehra, chief financial officer and cofounder of UGO Rx, and Scott Cady, PharmD, during the Total Pharmacy Solutions Summit Fall 2023 to discuss how pharmacists can maximize opportunities to improve their stores.

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Opinion: Sen. Maggie Hassan on what Congress must do next to fight the opioid crisis

STAT

Few public health challenges have been more daunting and persistent than the opioid crisis, which started because of egregious conduct by opioid manufacturers and now is driven by an influx of fentanyl. In my home state of New Hampshire — which has been at the forefront of this heartbreaking epidemic for more than a decade — too many promising futures have been snatched away.

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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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JPM24: Cigna's top brass says PBM Express Scripts is poised to weather industry reform

Fierce Healthcare

Last August, Blue Shield of California made headlines when it rev | As the market shifts toward greater transparency, Express Scripts has rolled out multiple programs in the past year that aim to address some of the central criticisms of the industry.

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STAT+: JPM 2024: FogPharma’s new CEO, Mathai Mamman, unveils ‘contrarian’ plan in oncology

STAT

SAN FRANCISCO — Six months into his tenure as CEO of cancer startup FogPharma, Mathai Mammen is taking the stage at the Westin St. Francis Tuesday for what he’s calling a “big unveil” of how he’s reshaping the biotech. And he’s prepared to go against the grain. Perhaps the most important thing he’s telling investors at the J.P.

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FDA Accepts sBLA for Tisotumab Vedotin-tftv for the Treatment of Recurrent, Metastatic Cervical Cancer

Pharmacy Times

The accepted sBLA comes after phase 3 clinical trial results which demonstrated better overall survival, progression-free survival, and confirmed overall response rate than chemotherapy in patients with cervical cancer.

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Data-driven disease research harnessing the genome

pharmaphorum

Discover how the UK Biobank is leveraging technology and the power of genomics in data-driven disease research. Join the digital revolution in understanding and combating diseases using cutting-edge techniques and large-scale genomic data analysis.

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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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Pharmacy Focus: The Development of "HARMACY," an Upcoming Documentary

Pharmacy Times

Anaïs Webster Mennuti, PharmD and Kristin Speer, PharmD, BCPS, discuss their new documentary that highlights the understaffed and overwhelmed reality of retail pharmacy.

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STAT+: Morgan Health wants you to know it’s still here

STAT

SAN FRANCISCO  — Almost three years ago, the country’s biggest bank unveiled a lofty plan to fix the health care industry’s entrenched problems. It broke off $250 million to stand up a new business unit, Morgan Health, to do so.  Today, Morgan Health’s CEO, Dan Mendelson, aided by a newly hired flack, emailed reporters attending that bank’s annual investor confab, the J.P.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. This article highlights the manifold applications of AI, particularly cutting-edge image recognition and computer vision systems, which profoundly impact quality control.

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Study Data Show Telemedicine Endocrinology Care Not as Effective as In-Person Care

Pharmacy Times

Patients who received telemedicine alone had worse glycemic control and less improvement in hemoglobin A1c levels.

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Digitisation of drug R&D: Avoiding new for novelty’s sake

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Aman Wasan, CEO of ArisGlobal, about the digitisation of drug research and development, including using automation to analyse large datasets to identify new drug development opportunities, with patient safety ever at the forefront of such innovations.

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Study: Drug interventions appear to have fewer disparities than other types of obesity care

Fierce Healthcare

Pharmacological interventions demonstrate fewer disparities in obesity treatment than behavioral and surgical treatment, a new literature review has found. | While most behavioral and surgical treatment studies reveal disparities in weight loss and clinical outcomes, pharmacological studies reveal minimal to no evidence of disparities and favorable outcomes for minorities.

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Astellas' gastric cancer candidate rejected by FDA because of manufacturing issues

Fierce Pharma

Two successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (C | Two successful phase 3 trials put Astellas’ monoclonal antibody zolbetuximab on track to become the first approved therapy to treat one of the hottest targets in oncology—tumors that are claudin (CLDN) positive.

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Merck, Johnson & Johnson Announce Acquisitions to Bolster Respective Oncology Pipelines

PharmExec

Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies.

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FDA blocks Astellas’ Claudin cancer drug over manufacturing

pharmaphorum

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug candidates for cancer.

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Native brings Girl Scout Cookie-inspired scents to personal care aisle

Drug Store News

The personal care collection, which features deodorant, deodorant and body spray, body wash, shampoo and conditioner, is inspired by the cookies, the brand noted.

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Benefits of saw palmetto for women

The Checkup by Singlecare

Taking saw palmetto can be beneficial for women of all ages. The historical use of saw palmetto includes regulating reproductive conditions, relieving cough , and increasing libido and sperm count in men. But this natural medicine can now be used for so much more. Dr. Kirby , a Nurse Practitioner at Health and Wellness Made Easy, says, “We usually think of saw palmetto for men and prostates, but this supplement can benefit women too.

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Life sciences marketing ahead: Unveiling the role of AI-powered innovations in HCP engagement

pharmaphorum

Discover how AI innovations are revolutionising the engagement between life sciences companies and healthcare professionals. Learn about the latest advancements and their impact on the industry.

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Implementing Technological Workflow May Usher in New Era of Pharmacy

Drug Topics

Placing telepharmacy at the forefront of outdated workflows could transform the traditional pharmacy setting.

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Walgreens to settle Humana arbitration dispute for $360M

Fierce Healthcare

Walgreens has agreed to a $360 million settlement in arbitration dispute with Humana, the company disclosed late last week. | Walgreens has agreed to a $360 million settlement in arbitration dispute with Humana, the company disclosed late last week.

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Sea moss benefits

The Checkup by Singlecare

What is sea moss? Sea moss, also known as Chondrus Crispus or Irish moss, is a type of red seaweed. Sea moss can be harvested year-round from inlets and tidal pools off the coast of North America, the British Isles, and Europe. Cleaned of sand and debris, the edible sea plant is then prepared to make powder or gel that can be used as supplements, food additives, or cosmetic products.

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JPM24: Roche says rebound in hematology sparked by potential of newly approved Lunsumio, Columvi

Fierce Pharma

After Roche went through a period of declining sales in hematology—as powerhouse Rituxan faced biosimilar competition and follow-on Gazyva failed to live up to its blockbuster expectations—the comp | After Roche went through a period of declining sales in hematology—as powerhouse Rituxan faced biosimilar competition and follow-on Gazyva failed to live up to its blockbuster expectations—the company is rebounding quickly in blood cancer.

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4 types of food to eat when nauseous

The Checkup by Singlecare

Nausea is an uneasiness in the stomach or an uncomfortable feeling in the back of the throat. Other symptoms like dizziness, lightheadedness, and trouble swallowing may accompany it. When you are experiencing symptoms of nausea, you may also vomit (throw up)—but nausea does not always lead to vomiting. Nausea may be associated with various illnesses, conditions, or treatments, such as: Cancer treatment (radiation or chemotherapy -induced nausea) Pregnancy (pregnant women may experience nausea an

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NACDS unleashes new TV ad urging Congress to get PBM reform done

Drug Store News

NACDS' new TV ad says the “clock is ticking” for vital Medicare and Medicaid reforms needed to protect Americans, communities and pharmacies.

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CMS opens door for New York Medicaid investments

Fierce Healthcare

Centers for Medicare & Medicaid Services approved New York's amended Medicaid section 1115 demonstration on Tuesday, spurring the agency to invest in behavioral health and health equity initiat | CMS is helping revamp Medicaid in New York, including more than $3 billion in investments for high-risk social needs services.

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Actress Madelyn Cline named newest Revlon global brand ambassador

Drug Store News

Cline will be featured as the face of the Revlon brand and products and across a marketing mix that includes in-store displays at retailer events and global campaigns.

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