Pharmacy Times

JULY 2, 2024

Artificial intelligence (AI) may optimize cash pricing strategies in community pharmacies.

Community Pharmacies 156

Community Pharmacies 156

STAT

JULY 2, 2024

As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people. In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time.

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Pharmacy Times

JULY 2, 2024

Donanemab-azbt is the first and only amyloid plaque targeting therapy that supports stopping therapy when the plaque is removed.

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FDA 139

STAT

JULY 2, 2024

Eli Lilly’s early Alzheimer’s treatment was approved by the Food and Drug Administration on Tuesday, making it the second drug on the U.S. market aimed at slowing progression of the debilitating neurological disease. The treatment, whose scientific name is donanemab and will be sold under the brand name Kisunla, will compete with Eisai and Biogen’s Leqembi, which got full approval last year.

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FDA 142

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

Patient Care

Fierce Pharma

JULY 2, 2024

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

FDA 138

FDA 138

STAT

JULY 2, 2024

Moderna has been awarded $176 million by the Biomedical Advanced Research and Development Authority to accelerate development of messenger RNA-based pandemic influenza vaccines, the company announced in a statement Tuesday. BARDA, a strategic preparedness arm of the Department of Health and Human Services, has said for weeks that it has been in talks with mRNA vaccine manufacturers with an aim to diversify the government’s pandemic flu vaccine response capacity.

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Vaccines Dosage 141

STAT

JULY 2, 2024

Why do Americans pay so much more for common medications than people in other countries? Why does an inhaler that costs $7 in France cost almost $500 in the United States? These are just a few of the questions the Senate Judiciary Committee looked to answer in a recent hearing. The common answer? Dominant corporations use a variety of patent-related strategies to protect their power, maximize their profits, and squash their competition.

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Pharmaceutical Companies Pharmaceutical Companies 140

Pharmacy Times

JULY 2, 2024

Pennsylvania, California, and New York were within the top 3 states, according to the findings.

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STAT

JULY 2, 2024

The unilateral decision by Peter Marks, a top official at the Food and Drug Administration, to approve the gene therapy Elevidys , a treatment for Duchenne muscular dystrophy, despite the misgivings of his staff, looks even more surprising on a close examination. Marks’ decision to overrule three different review teams appears unprecedented in recent FDA history.

FDA 139

FDA 139

Pharmacy Times

JULY 2, 2024

By taking a research-based approach, clinical trials can become more diverse and better serve the needs of all individuals.

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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.

STAT

JULY 2, 2024

The Food and Drug Administration’s rare pediatric disease priority review voucher program , which has been providing incentives for lifesaving innovations since 2012, is doomed to disappear unless Congress reauthorizes it before the end of September. Some lawmakers have downplayed its impressive track record based on unfounded allegations. I have data showing it works.

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Labelling FDA 135

Fierce Healthcare

JULY 2, 2024

The House Ways and Means Committee advanced bipartisan legislation on Thursday that would grant Medicare coverage to novel medical technologies for four years while the Centers for Medicare & M | The House Ways and Means Committee advanced updated legislation to expedite Medicare coverage of breakthrough medical devices. The new version of the bill reduces its cost by 75%, according to co-sponsor Rep.

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Drug Topics

JULY 2, 2024

Donanemab-azbt was approved under the FDA's Fast Track Review, Priority Review, and Breakthrough Therapy designations.

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FDA 123

Fierce Healthcare

JULY 2, 2024

It didn’t take long for hospitals to bring the Supreme Court’s dismantling of the Chevron deference into their crusade against the formula for disproportionate share hospital (DSH) payments. | The complaint questioning CMS' formula for enhanced rates was filed the same day the Supreme Court gutted federal agencies' ability to interpret ambiguous statute.

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Hospitals 125

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.

FDA

STAT

JULY 2, 2024

A looming anti-China biotechnology bill has spooked U.S. life sciences companies, according to a new report. The report by the China-based L.E.K. Consulting quantifies what until now has been mostly a vibe check. At this year’s Biotechnology Innovation Organization’s international conference, multiple biotech companies told STAT they plan to switch from striking deals with Chinese companies to U.S.

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Fierce Healthcare

JULY 2, 2024

The Biden administration has awarded $206.3 million of funding to clinician training programs to bolster the nation’s geriatrics care workforce. | Forty-two programs training physicians, nurses and other clinicians will integrate geriatric care training into their primary care programs.

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Pharmacy Times

JULY 2, 2024

Chimeric antigen receptor (CAR) T-cell therapy can engineer T cells to target malignant cells in multiple myeloma.

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Fierce Healthcare

JULY 2, 2024

Healthcare data company OMNY Health announced partnerships with two healthcare artificial intelligence companies, Aris Global and Quant Health on Tuesday. | OMNY Health announced it will supply its living data layer of over 70 million patients to power AI solutions from Aris Global and Quant Health. This is the first step the company is taking in the AI space, which is in desperate need of a scalable data solution, OMNY executives say.

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pharmaphorum

JULY 2, 2024

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

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Pharmaceutical Technology

JULY 2, 2024

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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pharmaphorum

JULY 2, 2024

The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book

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Fierce Pharma

JULY 2, 2024

In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.

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pharmaphorum

JULY 2, 2024

Explore the latest hires in pharma and biotech, including executive moves at Seaport Therapeutics, Anthos Therapeutics, Pfizer, and Novartis, from April 2024. Stay updated with the industry's top talent movements.

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Fierce Pharma

JULY 2, 2024

The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. | The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. anytime soon, after the China-approved drug flunked a pivotal trial in a rare cancer, forcing its stateside developer Tracon to explore strategic alternatives.

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Immunization 113

Drug Topics

JULY 2, 2024

Three posters presented at the American Diabetes Association 84th Scientific Sessions examined GLP-1 use and cardiovascular disease risk in several different patient populations.

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Fierce Pharma

JULY 2, 2024

With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.

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Vaccines 111

Pharmacy Times

JULY 2, 2024

The committee, after being presented evidence by the working group, recommended the vaccine for adults aged 65 and older and those 19 or older who have current recommendations to receive a pneumococcal vaccine.

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Vaccines 107

Fierce Pharma

JULY 2, 2024

Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

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Pharmaceutical Technology

JULY 2, 2024

Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.

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FDA 105

Fierce Pharma

JULY 2, 2024

In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.

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The Checkup by Singlecare

JULY 2, 2024

If you’ve been diagnosed with hypertension (high blood pressure), your healthcare provider may prescribe Zestril ( lisinopril )—a widely-used ACE inhibitor—to help manage your condition. On top of lowering blood pressure, it can treat heart failure and help improve survival after a heart attack. For high blood pressure, this medication is taken daily, on a long-term basis.

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FDA 105

Fierce Pharma

JULY 2, 2024

As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap. | As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap.

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pharmaphorum

JULY 2, 2024

Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.

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