Wed.May 22, 2024

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Type 2 Diabetes Impacts Mental Health, but Continuous Glucose Monitors Can Help

Drug Topics

A report from Dexcom found that depression and anxiety are commonly reported in patients living with type 2 diabetes, but continuous glucose monitors can make disease management easier.

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FDA Grants Tina-qant Lp(a) Assay Breakthrough Device Designation

Pharmacy Times

A lipoprotein (a) (Lp[a]) assay has been granted breakthrough device designation to expand identification of patients with elevated Lp(a) and genetic predispositions to cardiovascular disease.

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Pharmacists Play Key Role in Warning Public About Dangers of Tianeptine Misuse

Drug Topics

Savannah Roberts Clary, PharmD, BCPS, CPGx, a clinical pharmacist with Aegis Sciences Corporation, talks about the dangers of tianeptine and how pharmacists can help warn the public about the potential hazards of tianeptine.

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Michigan reports a human case of bird flu, the nation’s second linked to H5N1 outbreak in dairy cows

STAT

A second human case of bird flu infection linked to the current H5N1 outbreak in dairy cows has been detected, in a farm worker who had exposure to infected cows, Michigan state health authorities announced on Wednesday. In a statement , health officials said the individual had mild symptoms and has recovered. Evidence to date suggests this is a sporadic infection, with no signs of ongoing spread, the statement said.

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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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Vitamin D Deficiency May Increase Gastrointestinal Bleeding Risk in Patients on Blood Thinners

Drug Topics

Study findings can raise awareness for both patients and health care providers about vitamin D deficiency as a potential contributor to bleeding risk, as well as lead to more personalized treatment approaches for patients on blood thinners.

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UnitedHealth argues algorithm lawsuit should be dismissed because patients didn’t spend years appealing denials

STAT

UnitedHealth Group should be released from a lawsuit that alleges its algorithm-based technology prematurely cut off care to its Medicare Advantage members, the company said in court filings this week, because patients and their families did not finish Medicare’s appeals process. “Plaintiffs have failed to exhaust the exclusive administrative appeal process set by the Medicare Act,” UnitedHealth’s lawyers argued.

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Wastewater testing specifically for bird flu virus will scale up nationally in coming weeks

STAT

Less than a month ago, researchers reported for the first time the ability to scan wastewater for signs of the H5 influenza virus currently sickening dairy cows in at least nine states across the U.S. That technology is now at the threshold of real-world use. WastewaterSCAN, an infectious disease-tracking sewage surveillance network led by Stanford University and Emory University in partnership with Verily Life Sciences, has begun scaling up H5-specific testing of samples from all of its 190 sit

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Unraveling the DSCSA Serialization Puzzle: Implications for Drug Shortages and Patient Care

Pharmacy Times

The pharmaceutical landscape faces challenges with drug serialization, including data discrepancies and potential shortages, but technology emerges as a beacon of hope for the industry.

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When should we start making H5N1 vaccine, and who will make that decision? In short, it’s complicated

STAT

If the H5N1 bird flu virus ever acquires the ability to transmit easily to and among people — keep your fingers crossed that it doesn’t — the world is going to need serious amounts of vaccine. Like, lakes of the stuff. Some manufacturers have been working with H5N1 viruses for years, producing small batches of doses that have undergone preliminary human testing.

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Semaglutide Access, Cost Issues Could be Addressed With New DNA Test

Drug Topics

Participants with the hungry gut phenotype, identified by the MyPhenome Hungry Gut test, were able to lose double the amount of weight on semaglutide compared to those without.

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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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Patients Receiving Psychiatric Care May Be at Increased Risk of Pandemic-Related Stress, But Are Not at Increased Risk of Believing in Conspiracy Theories

Pharmacy Times

Experts emphasize the importance of awareness when using social media and make suggestions on how to combat the spread of misinformation and conspiracy theories.

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STAT+: Cue Health, Covid-19 testing company, is shutting down

STAT

In an abrupt change of course from plans earlier in the month, at-home test maker Cue Health is laying off all of its employees and shutting down as of Friday, May 24. The company, which grew to prominence during the Covid-19 pandemic as the maker of one of the only molecular at-home tests for the virus, has been teetering on the edge of insolvency for months.

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Epic releases open-source AI validation tool for health systems

Fierce Healthcare

Epic launched an open-source tool on Wednesday to enable healthcare organizations to test and monitor artificial intelligence models. | Six weeks after announcing it was developing an AI validation software tool for healthcare, Epic has launched the open-source tool on Github to help health systems test and validate AI models.

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Phase 2 Study Demonstrates Oral Rilzabrutinib Reduces Loss of Control Events in Patients With Asthma

Pharmacy Times

According to the investigators, these findings support the investigation of rilzabrutinib in patients with asthma in a phase 3 trial program.

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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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Express Scripts, CPESN team up to support independent pharmacies in providing key services

Fierce Healthcare

Express Scripts will partner with CPESN in the latest evolution of its IndependentRx Initiative, which aims to boost independent and community pharmacies. | Express Scripts will partner with CPESN in the latest evolution of its IndependentRx Initiative, which aims to boost independent and community pharmacies.

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Pfizer, busy with $4B savings drive, plots even more cuts out to 2027

Fierce Pharma

Pfizer has made frequent headlines in recent months as it moves forward with a campaign to save $4 billion in annual costs by the end of this year. | Pfizer has made frequent headlines in recent months as it moves forward with a campaign to save $4 billion in annual costs by the end of this year. Now, the company has unveiled another savings drive that will run longer.

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Financial Incentives Show Significant Success for Weight Loss in Men

Drug Topics

Researchers analyzed groups of men given financial incentives to motivate weight-loss behaviors compared with a non-incentivized control group.

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NICE and the controversy over a ‘clinically distinct disease’ designation

pharmaphorum

The debate rages on as NICE considers a 'clinically distinct disease' classification. Learn how this decision could reshape the STA process and patient treatment options.

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Can Smoking and Its Resulting Carbon Monoxide Exposure Improve Cancer Treatment Outcomes?

Pharmacy Times

Smoking increases exposure to carbon monoxide, and this may be associated with better clinical response to autophagy inhibitors.

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Tony Blair Institute weighs in on use of NHS patient data

pharmaphorum

A think tank set up by former UK Prime Minister Tony Blair has called for the formation of a public-private trust that could oversee the sharing of anonymised patient data with trusted researchers.

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STAT+: Cytokinetics sells Royalty Pharma a share of its heart drug for up to $575 million, lowering hopes of a buyout

STAT

Cytokinetics, a drugmaker that is expected to soon launch a promising new heart therapy called aficamten, said Wednesday that it had agreed to pay biotech firm Royalty Pharma a higher royalty on the medicine in return for up to $575 million, which will be used to fund the marketing of the drug and Cytokinetics’ ongoing research and development efforts.

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Hospitals grapple with generic drug supply shortages

Fierce Healthcare

In this week’s episode of “Podnosis,” we’re diving into the issue of generic drug shortages. | In this week's "Podnosis" episode, Fierce Healthcare’s Dave Muoio talks with Allan Coukell from Civica Rx about generic drug shortages. Coukell discusses the impact on healthcare providers, recent strategies to strengthen the drug supply chain and advice for organizations facing these shortages.

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GSK’s twice-yearly asthma drug clears two phase 3 trials

pharmaphorum

GSK’s follow-up to its severe asthma therapy Nucala has shown its value in a pair of phase 3 trials, reducing exacerbations compared to placebo with dosing once every six months. The company says new IL-5 inhibitor depemokimab (formerly GSK3511294) has the potential to become the first ultra-long-acting biologic for severe asthma with a six-monthly dosing schedule.

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Inside the breathtaking world of therapeutic psychedelics: Great promise and great challenges

Fierce Healthcare

Marcus Capone felt he had run out of options. | Advocates say psychedelic drugs changed their lives and helped cure serious mental conditions when antidepressants failed. But accessing these therapies at an affordable price is a huge challenge.

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Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

Fierce Pharma

Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on m | Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on measures of agitation associated with dementia.

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Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

STAT

WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder. But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests.  The data, presented this week as an abstract at Digestive Disease Week in D.C., suggest anti-seizure gabapentinoids might be a simple and effective treatment for slowing the progression of alcohol-associated liver disease.

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New NIH findings on talc use and ovarian cancer pose challenge to J&J's high-stakes defense

Fierce Pharma

The more than 53,000 women in the U.S. | The more than 53,000 women in the U.S. who have filed injury lawsuits against Johnson & Johnson have added ammunition for their claims as new research indicates there is an association between long-term use of talcum-based powders and an increased risk of developing ovarian cancer.

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US senators accuse pharma firms of abusing patent system

pharmaphorum

Lawmakers across the political divide have accused the pharma industry of abusing the patent system to keep the prices of their products as high as possible.

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STAT+: Biogen joins immunology wave with $1.15 billion acquisition

STAT

Biogen is joining the industry’s fervor over immune and inflammatory disease drug development with a new acquisition. The Cambridge, Mass., drugmaker announced Wednesday that it will acquire Human Immunology Biosciences , or HI-Bio, for $1.15 billion and up to $650 million in additional payments if certain milestones are met. HI-Bio, which is based in San Francisco, is developing therapies for immune-mediated diseases like primary membranous nephropathy and IgA nephropathy, both of which

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Click buys Better assets to speed its digital obesity drive

pharmaphorum

Digital health firm Click Therapeutics has bought the assets of Better Therapeutics to speed up development of a prescription digital therapeutic for obesity

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STAT+: New antiviral works against coronaviruses in mice, but human testing will have to wait

STAT

During the Covid-19 pandemic, vaccines were the main line of defense. Startlingly effective shots quickly helped immunize a large portion of the population — at least initially, and in high-income countries. Antiviral treatments were not as impactful. Remdesivir requires transfusions, which made it difficult to access; Paxlovid is easier to obtain, but has more unpleasant side effects, and carries the risk of rebound.

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ASCO: Data detail Verzenio's flop in prostate cancer as Lilly seeks redemption via radiotherapy

Fierce Pharma

Eli Lilly has in the past few months unveiled two back-to-back trial flops for Verzenio in prostate cancer. Now, we know exactly how one sputtered. | Eli Lilly recently unveiled two back-to-back trial flops for Verzenio in prostate cancer. Now, we know exactly how one sputtered.

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Ultragenyx must face lawsuit over HeLa cell use for profit

pharmaphorum

Ultragenyx has failed in its attempt to have a lawsuit filed by the Henrietta Lacks estate claiming the company profited from HeLa cells dismissed before it could be heard

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No nitrosamines: How parenteral packaging is evolving to meet today’s E&L challenges

Pharmaceutical Technology

As the nitrosamine scandal continues, we explore the advancements in parenteral packaging materials that are reducing the risk of this contaminant in modern injectables.