Fri.Aug 09, 2024

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Cannabis Use Associated with Increased Risk of Head and Neck Cancer

Drug Topics

A cohort study was conducted to address the association between patients with cannabis-related disorders and their risk of developing head and neck cancer.

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Opinion: Noah Lyles’ collapse with Covid: How not to manage health at the Olympics

STAT

Noah Lyles, a 27-year-old from Gainesville, Florida, has had himself quite an Olympics. He won a gold medal in a photo finish in the 100-meter dash on August 4. He went on to win a bronze medal in the 200-meter dash four days later, then collapsed in a heap and needed a wheelchair to get off the track, suggesting that sports officials and team doctors have put athletes’ health last, not first, during the Paris Olympics.

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Trending Sources

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The 2024-2025 Flu Season: What to Expect

Drug Topics

The composition of the latest flu vaccine has changed. Here’s what pharmacists need to know.

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FDA approves EpiPen alternative, a nasal spray for anaphylaxis

STAT

On Friday, the Food and Drug Administration approved the first needle-free treatment for adults and kids with severe allergic reactions. The approval introduces a competitor from ARS Pharma to older epinephrine products, like the EpiPen. Neffy, as the product is called, is a nasal spray that delivers the same drug used to treat anaphylaxis. It is ARS’ flagship product.

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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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FDA Rejects MDMA-Assisted Therapy to Treat PTSD in Setback for Psychedelic Medicine

Drug Topics

The agency said it could not approve the new drug application based on the submitted data and requested an additional Phase 3 trial to “further study the safety and efficacy” of the therapy.

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FDA Declines to Approve MDMA for PTSD

Pharmacy Times

Previously, an independent advisory panel for the FDA rejected the use of MDMA-assisted therapy for posttraumatic stress disorder (PTSD), citing concerns of the reliability of the clinical trial data.

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More Trending

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FDA Approves First Nasal Spray for Anaphylaxis

Pharmacy Times

neffy is an epinephrine nasal spray for the emergency treatment of allergic reactions in adults and pediatric patients.

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FDA rejects MDMA as a psychedelic treatment for PTSD

STAT

The Food and Drug Administration rejected MDMA as a treatment for post-traumatic stress disorder on Friday, in a blow to drug activists and veterans who’ve long campaigned for the psychedelic treatment. Although two Phase 3 trials suggested the treatment was effective, strong opposition by an agency scientific advisory committee in June and allegations of missing adverse event data and research bias may have doomed the application by Lykos Therapeutics.

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FDA Approves First Needle-Free Epinephrine Nasal Spray

Drug Topics

The epinephrine nasal spray from ARS Pharmaceuticals has become the first and only needle-free epinephrine alternative and the first new delivery method for epinephrine in over 3 decades.

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New Study Assesses Ifinatamab Deruxtecan for Treatment of Small Cell Lung Cancer

Pharmacy Times

The study is expected to include 460 individuals that will be randomly treated with 12mg of ifinatamab deruxtecan or chemotherapy chosen by the health care provider.

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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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STAT+: A bespoke genetic therapy is helping Susannah. Can similar drugs be made at scale for other rare diseases?

STAT

Will it work? It was the question everyone around Susannah Rosen kept asking. Since infancy, she’d lived with a rare neurologic disease. She’d struggled to walk and talk, only to have the degenerative disease mostly rob her of those skills. Hardly a day passed without her suffering seizures, leaving her in need of constant care. But in October 2022, Susannah’s family had reason to be hopeful.

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Walgreens may sell entire stake in VillageMD business as it explores strategic options

Fierce Healthcare

Drugstore chain Walgreens is considering a full sale of its stake in VillageMD after investing billions in the primary care provider. | Walgreens said its exploring options including a sale of all or part of the VillageMD businesses, possible restructuring options and other strategic opportunities, according to a recent filing.

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Opinion: Medicine needs fiction, especially now

STAT

The American medical system needs fiction because, as Albert Camus supposedly said , “Fiction is the lie through which we tell the truth.” And those in health care, from hospital administrators to clinicians and technicians, need to hear the real truth about health care. For decades, a small group of physician and nurse writers has provided behind-the-scenes looks at the experiences of being a doctor, the lives saved, the ones lost, and how the profession has changed the way many p

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Medicaid, MA headwinds pressure payers in Q2. Here's a look at how major companies fared

Fierce Healthcare

Medicare Advantage and Medicaid woes continued to plague some major payers in the second quarter, with UnitedHealth Group regaining its crown as the most profitable company in the industry for Q2.< | Medicare Advantage and Medicaid woes continued to plague some major payers in the second quarter, with UnitedHealth Group regaining its crown as the most profitable company in the industry for Q2.

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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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MDMA therapy is facing an imminent FDA decision. Here’s what you need to know

STAT

A decades-long campaign to legalize MDMA as a mainstream medical treatment will reach a climax as soon as Friday, with the Food and Drug Administration poised to decide whether the psychedelic should be approved as a treatment for post-traumatic stress disorder in conjunction with psychotherapy. The regulators face an Aug. 11 deadline to decide whether to sign off on the drug or reject it.

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New Evidence Supports Cholesterol Absorption Inhibitors in Liver Cancer Prevention

Pharmacy Times

Statins and non-statin cholesterol-lowering agents show potential in reducing the risk of liver cancer.

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Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

Fierce Pharma

With Gilead's stated focus to grow in oncology, the company's recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. | The HIV-focused drugmaker looks to position its long-acting Sunlenca as a prime PrEP option after the med aced a phase 3 study.

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Clinical Presentation in Patients With Lymphoma Widely Vary, Making Treatment Difficult

Pharmacy Times

A variety of signs and symptoms of lymphoma were reported, including fever, stomach discomfort, and weight loss.

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Purdue, after playing major role in US opioid epidemic, wins FDA nod for overdose-reversal injection

Fierce Pharma

As Purdue Pharma attempts to restore its image following its role in | As Purdue Pharma attempts to restore its image following its role in the U.S. opioid crisis, the Connecticut-based company has scored a win with a green light for a new overdose rescue treatment.

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8 benefits of berberine

The Checkup by Singlecare

Berberine is an alkaloid, a yellow compound extracted from several different plants—such as the barberry plant ( Berberis vulgaris L. ), tree turmeric, goldenseal, and Oregon grape. It’s also found in over-the-counter (OTC) dietary supplements. Historically, berberine has been used in Ayurvedic and traditional Chinese medicine for centuries to treat wounds, infections, and other health conditions.

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Research Identifies Key Genes Linking Hashimoto Thyroiditis and Papillary Thyroid Carcinoma

Pharmacy Times

The findings may lead to the development of diagnostic and therapeutic targets to prevent worsening disease in patients.

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New Report Scrutinizes PBM Spread Pricing Practice

Drug Topics

Findings from the study conducted by 3 Axis Advisors confirm that PBM practices have an impact on pharmacies.

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Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor

Fierce Pharma

Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged. | Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged.

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Opinion: Small changes in food ‘choice environments’ in stores can make a healthy difference

STAT

I usually do my grocery shopping at the end of the day when I am tired, stressed, and hungry. In a word, I am vulnerable. The sugary beverages, candy, baked goods, and salty snacks located at the front entrance, aisle end caps, and checkout lanes can be hard to resist. The food industry knows this about me — and you. But small changes in the “choice architecture” can help people avoid these unplanned impulse purchases and choose healthy foods.

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The Role of Pharmacists in Addressing Patient-Specific Factors and Advancing CAR T Cell Therapy

Pharmacy Times

Dan Schrum discusses the integral role of pharmacy specialists in translating clinical trial results to clinical practice.

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Morning Rounds: Another Ebola outbreak?

STAT

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. I’m working on a playlist for an upcoming road trip. Got song suggestions for driving across vast landscapes? Email me: brittany.trang@statnews.

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Minutes to answers: Compliant chat builds more meaningful HCP relationships

pharmaphorum

Compliant chat ensures that Healthcare Professionals (HCPs) receive accurate information in a timely manner, fostering more meaningful relationships. Learn how to navigate compliance in your interactions with HCPs.

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Pharma execs react to final drug price negotiations with Medicare

PharmaVoice

Here’s what the leaders of the companies with the 10 drugs in the first wave of price negotiations with Medicare said about how the new prices will impact their portfolio.

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Lilly's tau drug for Alzheimer's flunks phase 2 test

pharmaphorum

Eli Lilly's oral tau drug fails to show efficacy in a phase 2 trial in Alzheimer's disease in another setback for the class

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STAT+: Pharmalittle: We’re reading about a California bill to restrain PBMs, a U.K. trade group scolding Novo, and more

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 fairly modest. We hope to catch up on our reading, spend time with our Pharmalot ancestor, and promenade with the official mascots. We also hope to hold another listening party, where the rotation will likely feature this ,  this ,  this , and  this.

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FDA Roundup: Implications of Potential MDMA Approval, Nalmefene for Opioid Overdose

Drug Topics

Check out important updates from the FDA for the week of August 5.

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Why did Novo pull heart failure paperwork for Wegovy?

STAT

Hey, humans. Today, we talk about the decades-long pursuit to get MDMA approved as a medicine for PTSD, in advance of Lykos Therapeutics’ Sunday PDUFA date. Also, we see a little girl’s ultra-rare disease improve after she was given a genetic medicine designed just for her, and more. The need-to-know this morning Merck acquired an experimental bispecific antibody from China-based Curon Biopharmaceutical for $700 million upfront, plus an additional $600 million in potential mileston

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Hormone Therapy May Reduce Risk of Alzheimer Disease Pathology, Cognitive Decline in Women

Pharmacy Times

Findings from 2 large datasets suggest hormone therapy may reduce Alzheimer risk, hippocampal atrophy, and cerebrovascular disease.

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In This Issue: Drug Topics July/August 2024

Drug Topics

See what’s trending in pharmacy with a preview of the Drug Topics July/August issue.

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