Tue.Jun 20, 2023

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How FDA’s modernization strategy could improve drug development

PhRMA

As technology continues to rapidly advance, it’s important for regulatory agencies like the U.S. Food and Drug Administration (FDA) to keep pace and adopt new technologies and approaches to support its public health mission and ultimately, better serve patients.

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FDA, Novo Nordisk Warn of Counterfeit Semaglutide Injection Pens

Pharmacy Times

A counterfeit medication was reportedly purchased at a retail pharmacy, appearing to have contained another type of diabetes medication that led to an adverse reaction.

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What’s New in Next-Generation Vaccines for Respiratory Viruses?

Drug Topics

A recent review evaluated possible approaches for new vaccines targeting respiratory viruses.

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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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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Current Dementia Risk Assessment Models Limited in Ability to Predict Disease

Pharmacy Times

Standard prediction models that assess an individual’s risk of developing dementia and how to prevent it are limited in their ability to do so, showing high error rates and a higher chance of receiving a false-positive result, according to a recent study.

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Agepha Pharma gets ancient gout remedy colchicine across FDA finish line for heart disease

Fierce Pharma

Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.

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More Trending

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Bristol Myers follows Merck's lead with its own ?lawsuit blasting IRA's Medicare negotiations

Fierce Pharma

After Merck filed a bombshell lawsuit challenging some measures in the Inflation Reduction Act (IRA), Bristol Myers Squibb has followed on with a case of its own. | After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations.

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STAT+: ‘It’s beyond unethical’: Opaque conflicts of interest permeate prescription drug benefits

STAT

Employers across the country — from big names like Boeing and UPS to local school systems — pay consulting firms to handle a straightforward task with their prescription drug coverage: Get the best deals possible, and make sure the industry’s middlemen, known as pharmacy benefit managers, aren’t ripping them off with unfair contracts.

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With new lawsuits, Novo Nordisk aims to crack down on compounded versions of Ozempic, Wegovy

Fierce Pharma

Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said.

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Opinion: Bloated patient records are filled with false information, thanks to copy-paste

STAT

I recently took care of a patient whose medical records included multiple notes about her past open-heart surgery. Only she had never undergone open-heart surgery.

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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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'Misinformation': AstraZeneca's China head refutes news report about potential spinoff

Fierce Pharma

AstraZeneca, the largest multinational pharma company in China, has reportedly made plans to separate its local business there in case geopolitical tensions worsen. | The largest multinational pharma company in China has reportedly made plans to separate its local business in case geopolitical tensions worsen. But the company is hitting back at the recent news report.

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AI Plus Mobile App May Help With Smoking Cessation

Pharmacy Times

More than 4 times as many people who used the app quit smoking compared to a traditional support service.

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Sanofi prevails over Boehringer Ingelheim in legal battle over Zantac liabilities

Fierce Pharma

When Sanofi made an asset swap with Boehringer Ingelheim in 2016, the French company acquired BI’s healthcare business, which included heartburn medicine Zantac. | An International Chamber of Commerce arbitration tribunal has sided with Sanofi, rejecting Boehringer Ingelheim's attempt to receive liability protections for cancer claims in the United States tied to heartburn medicine Zantac.

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Oregon nurses' 5-day strike forces Providence to limit nonemergency services

Fierce Healthcare

About 1,800 of Providence’s Oregon nurses and clinicians are on strike this week amid contract negotiations, prompting the health system to cut back some services at its facilities to preserve capa | Contract disagreements led 1,800 union nurses to the picket lines this week. To cope, Providence has hired replacement staff and is limiting several services and transfers at three locations: Providence Portland Medical Center, Providence Seaside Hospital and Providence Home Health and Hospice.

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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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In fraud case targeting HIV meds, Florida man gets 15 years in prison

Fierce Pharma

A year after a Florida man was arrested for his alleged involvement in a nationwide scheme to distribute fake HIV medicines, a U.S. | After reaping millions from selling adulterated HIV meds, one of the men involved in a fraud ring has been sentenced to 15 years in prison for his role in the crime.

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NYU Langone sues competitor Northwell over 'confusingly similar' purple ads

Fierce Healthcare

NYU Langone Health System is suing to block competitor Northwell Health from running ads the former said are mimicking its long-established color palettes and encroaching on its reputation. | NYU Langone Health System alleges that Northwell Health began to intentionally run similar ads in 2019 to cash in on the former's "outstanding reputation.

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After metastatic disease win, Merck's Keytruda flunks trial in early stomach cancer

Fierce Pharma

Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix. | Immune checkpoint inhibitors haven’t had tons of success in stomach cancer. Now, Merck has added one failure to the mix.

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'Podnosis': Health equity, measuring social determinants of health

Fierce Healthcare

This week the Fierce newsroom took the day off to honor Juneteenth. So we've selected a few favorite segments from the fall of 2022 to reshare in this week's episode. | This week on "Podnosis," we talk about the momentum behind addressing health equity challenges. Also under discussion is how social drivers of health are finally being recognized by CMS.

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Multivitamin Supplementation May Be Linked With Improved Nutrition in Older Men

Pharmacy Times

Multivitamins were associated with increased cellular oxygen consumption and more optimal blood nutrition biomarkers.

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STAT+: Eli Lilly to acquire DICE Therapeutics in $2.4 billion deal

STAT

Eli Lilly said Tuesday that it will purchase DICE Therapeutics, a small company developing an experimental pill to treat psoriasis, for $2.4 billion in cash. The deal price of $48 per share represents a 42% premium to DICE’s closing price Friday. “In combination with its novel technology and expertise in drug discovery, DICE’s talented workforce and passion for innovation will enhance our efforts to make life better for people living with devastating autoimmune diseases,

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Novel Combination Antibiotic Shows Efficacy in Serious Bacterial Infections due to Gram-negative Bacteria

Pharmacy Times

The novel antibiotic combines aztreonam, a monobactam β-lactam, with avibactam, a broad-spectrum β-lactamase inhibitor.

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Who should not take probiotics?

The Checkup by Singlecare

It might seem odd that ingesting live microorganisms—essentially, germs—can be good for your health, but that’s the idea behind probiotics. Probiotics have become a popular supplement for people searching for better gut health and improved overall health. But not everyone should take probiotics. They can cause unwanted side effects, such as bloating, gas, or constipation.

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Catalyst licenses Santhera Pharma’s vamorolone in North America

Pharmaceutical Technology

Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region. The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.

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Does diverticulitis go away?

The Checkup by Singlecare

If you have diverticulosis , a.k.a. small pockets inside the lining of your colon, there’s a chance you’ve experienced diverticulitis, or the inflammation and infection of one of those pockets. Diverticulosis is relatively common, affecting around 50% of people over 60 , though it often doesn’t cause symptoms, and people may not know they have it. Diverticulitis, on the other hand, is less common but more problematic.

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Equip taps healthcare exec Nikia Bergan as new president to scale up virtual eating disorder treatment services

Fierce Healthcare

Healthcare startup Equip has tapped former Get Well executive Nikia Bergan as its first-ever president to shepherd the company through its next growth phase. | Healthcare startup Equip has tapped former Get Well executive Nikia Bergan as its first-ever president to shepherd the company through its next growth phase.

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Bausch + Lomb debuts PreserVision AREDS 2 Formula soft gels plus CoQ10

Drug Store News

The soft gels contain the nutrient formula recommended by the National Eye Institute to help reduce the risk of moderate to advanced age-related macular degeneration progression in AMD patients.

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STAT+: Novo Nordisk sues spas and clinics for selling versions of Wegovy and Ozempic for weight loss

STAT

In the latest fracas over obesity drugs , Novo Nordisk filed lawsuits alleging several medical spas, wellness clinics, and weight loss clinics around the U.S. are illegally selling compounded versions of its medicines. The drugmaker accused the businesses of false advertising, unfair competition, and infringing on trademarks for three medicines: Wegovy, Ozempic, and Rybelsus.

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AI has secured a footing in drug discovery. Where does it go from here?

PharmaVoice

The AI revolution is bringing a new era of drug discovery, and the potential for more uses is greater and faster than ever before.

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STAT+: Pharmalittle: Opaque conflicts permeate prescription drug benefits; Sanofi prevails in Zantac arbitration

STAT

Rise and shine, everyone, another busy day is on the way. We can tell by the number of people walking past and cars whizzing by the Pharmalot campus this morning. These are among our usual proxies for gauging the state of the world outside our window. All of this is to say there is much to do. So time to get cracking. We are firing up the coffee kettle and brewing a cup of stimulation — salted caramel mocha is the choice right now — and digging out the to-do list.

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E.l.f. Cosmetics launches inspirational 'Show Your(s)e.l.f.' series

Drug Store News

The beauty brand’s first video will include the story of Anastasia Pagonis, a 19-year-old blind Paralympic swimmer and world record holder.

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STAT+: The FDA is testing new nutrition labels on the front of food packages

STAT

WASHINGTON — The FDA wants to make it easier for consumers to know if the foods they’re buying are unhealthy — but doing so is harder than it seems here in the United States. Much of the Americas already has so-called front of package labels — small symbols printed on packaged foods that alert consumers when a food is high in certain unhealthy nutrients like sodium or saturated fat.

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Wet n wild goes down the rabbit hold with Alice in Wonderland collection

Drug Store News

The Alice in Wonderland x wet n wild collection features accessories and products with bright pigments and clean skin-enhancing formulas, the brand noted.

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STAT+: Top federal lobbyist at PhRMA leaves

STAT

WASHINGTON — The top federal lobbyist for the brand drug lobby PhRMA is leaving, two drug industry lobbyists and one health care lobbyist told STAT on Tuesday. Anne Esposito, who was the trade group’s senior vice president for federal advocacy, played an important role in shaping PhRMA’s lobbying strategy over her three and a half years at the organization.

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Dollar General to expand into Montana

Drug Store News

Dollar General is planning to open its first store in Montana in fall 2023, which will give the retailer a presence in its 48th state.

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