Thu.May 09, 2024

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Insulin App Recall Prompts FDA Warning After More Than 200 Reported Injuries

Drug Topics

Tandem Diabetes Care, Inc has reported 224 injuries associated with a software malfunction in a companion insulin app, leading the company to issue a recall of the technology.

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Bird flu keeps rewriting the textbooks. It’s why scientists are unsettled by the U.S. dairy cattle outbreak

STAT

Twenty-seven years ago today, a 3-year-old boy in Hong Kong developed a sore throat, spiked a fever, and started to cough. Six days later, he was hospitalized; six days after that, he died of acute respiratory distress caused by viral pneumonia. Testing showed the toddler, who’d had contact with sick chickens before becoming ill, had been infected with H5N1 bird flu.

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Justice Department 'upping its game' on healthcare antitrust enforcement with new task force

Fierce Healthcare

The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion. | The U.S. Department of Justice announced Thursday it has established a new task force to take on healthcare monopolies and collusion.

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Opinion: H5N1 communication has been strictly for the birds. Didn’t the federal government learn anything from Covid?

STAT

When it comes to federal agencies communicating to the public about H5N1 bird flu, it feels like a classic case of Yogi Berra’s déjà vu all over again. In the wake of pointed criticism about its failure to release new information about the growing H5N1 outbreak in livestock, the Animal and Plant Health Inspection Service of the U.S.

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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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Mental Health Awareness Month: The Importance of Advocating For Yourself and Others

Pharmacy Times

A clinical pharmacist discusses his work in the mental health space while stressing the importance of advocating for and checking in with one another’s emotional well-being.

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A new cholera vaccine will increase supply, but will it be enough to manage global outbreaks?

STAT

Weeks after the global public health community sounded the alarm on the shortage of cholera vaccine, the World Health Organization moved to prequalify a new cholera vaccine last month. The vaccine is a simplified version of the two existing oral vaccines, both produced by Korean vaccine manufacturer EuBiologics Co. The company will begin making the new vaccine, called Euvichol-S, this year.

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More Trending

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STAT+: Health care leaders plot how to expand diversity in clinical trials

STAT

Even with the recent awareness that clinical trials often lack the diversity that would make them representative, women and people of color remain underrepresented in studies. The work of bringing diversity to research is complex, and several experts gathered at the Milken Institute Global Conference on Wednesday to discuss potential strategies to make progress, starting with ways to build trust among the communities that have a history of being mistreated or exploited by the scientific communit

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Community Pharmacists Tackle Asthma Medication Adherence

Pharmacy Times

This study is the first to preliminarily show that a community pharmacist intervention can produce a positive effect on reducing SABA reliance and improvement of ICS adherence in patients with asthma.

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STAT+: Drug supplies for millions would be jeopardized by U.S. crackdown on China biopharma industry, trade group says

STAT

U.S. legislation that would sever ties with Chinese drugmakers would jeopardize the drug supply for millions of American patients if it’s passed, the biotechnology industry’s main trade group has told Congress. Congress is considering legislation, called the BIOSECURE Act, that would make it difficult for Chinese contract development and manufacturing organizations to do business with biotechnology companies that work with the U.S. federal government.

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A CPT code for prior authorization? Here’s how it could happen

Fierce Healthcare

One physician is making the case that prior authorization for procedures should be reported to insurance plans as a CPT code—and the proposal could pass this week at an American Medical Association | A New York urologist believes prior auth CPT codes will realign incentives and better support patients and physicians.

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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+: Getting Alzheimer’s treatment to those who need it poses particular challenges

STAT

A host of hurdles are slowing the adoption of the new Alzheimer’s drug Leqembi, experts involved in the treatment of patients said Wednesday, from complicated logistics to the fact that many people don’t recognize that their memory loss is a disease soon enough. Some patients still grapple with whether they want to be diagnosed, even though a treatment exists, the experts said, speaking during a STAT virtual event.

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Medicare Advantage risk assessments driving billions in costs each year

Fierce Healthcare

Medicare Advantage plans have come under fire for upcoding that can increase the payouts they receive, and regulators point to health risk assessments as a likely culprit in this increase in coding | Medicare Advantage plans have come under fire for upcoding that can increase the payouts they receive, and regulators point to health risk assessments as a likely culprit in this increase in coding intensity.

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Opinion: Caring for young caregivers, a hidden population

STAT

The intersection of the mental health crisis among young Americans and the growing burden of unpaid caregiving is generating an expanding, particularly vulnerable, and unacknowledged population: young people who act as caregivers for siblings with special health care needs, physically or mentally ill parents, ailing grandparents, or other loved ones.

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Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

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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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Listen: Everything you need to know about H5N1 bird flu

STAT

What happens when a common virus jumps from birds to cows? And should we be concerned? This week on “The Readout LOUD,” STAT senior infectious diseases reporter Helen Branswell walks us through ongoing H5N1 outbreak in the U.S. and issues with monitoring the spread.

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Ways and Means Committee's rural care markups win hospital industry praise

Fierce Healthcare

A slew of bills targeting enhanced access to care within rural communities have, to the applause of the hospital industry, passed through committee to the full House of Representatives. | A handful of bills sent to the full House Wednesday would extend or expand greater funding for various types of rural hospitals. In statements to the legislative committee, AHA and FAH broadly applauded the bills but outlined some suggestions that would preserve hospital lobby interests.

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Exact Sciences’ stock tumbles amid worries cancer detection firm’s growth may slow

STAT

Exact Sciences reported first-quarter revenues this week that beat market expectations, and the cancer detection company’s executives still believe they’re on track to meet expected 2024 revenue. That’s usually good news. Yet Exact shares are down nearly 11% on Thursday, dipping to $53.12 within the first few hours of trading. During after-hours trading on Wednesday, shortly after Exact released its financial updates, shares tumbled as low as $47.24.

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New metric predicts burden of participating in trials

pharmaphorum

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

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Yet another big financing round in immunology

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Congratulations on almost making it to the end of the week! For that, I have a little treat for you at the bottom of the newsletter.

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Q&A: Biosimilar Access, Pricing in the Spotlight

Drug Topics

Since biosimilars first launched, unique pricing incentives and strategies have been created to incentives adoption.

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Q&A with Jennifer Adair, researcher on a mission to increase global access to gene therapies

STAT

BALTIMORE — Gene and cell therapies have transformed a handful of devastating disorders in the U.S. and Europe, with more treatments on the way. But those technologies have largely failed to reach most of the world. These lags are ubiquitous in the current drug development system, where new therapies are approved in wealthy countries and then slowly leak out to low- and middle-income countries, many years later.

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Widespread PA Use in Medicare Advantage Restricts Health Care Utilization

Drug Topics

Researchers analyzed the prior authorization requirements of private insurers applied to various Medicare services.

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STAT+: Cytokinetics set to pitch its heart drug to physicians — and Big Pharma suitors

STAT

This is the online edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered every Thursday to their inbox. I love the Cytokinetics story. There’s so much at stake with aficamten, not to mention all the ups and downs from previous drug-development efforts and now the speculation about a possible takeover.

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Understanding the evolution of container closure integrity testing

pharmaphorum

How have drug container closure testing methods changed over time? This post explores the history and development of techniques to evaluate container integrity.

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STAT+: Pharmalittle: We’re reading about Takeda restructuring, Pfizer settling Zantac suits, and more

STAT

Rise and shine, everyone, another busy day is on the way. We can tell because countless birds are chirping outside our window, the pace of motor vehicles passing by our window is picking up, and the official mascots are busy foraging for snacks on the official grounds. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is orange cream.

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LogiPharma Europe 2024: Delivering Agility in Supply Chains Through Building Multimodal Cold Chain Networks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Cathy O'Brien, VP of Sales, UPS Healthcare discusses her masterclass on delivering agility in supply chains by building a multimodal cold chain network while also reducing risks at LogiPharma Europe 2024.

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Q&A: How The 2024 Election Looms Large Over Pharmacy

Drug Topics

One of the biggest issues pharmacists are watching is the Medicare Part D redesign and copay smoothing policy.

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It’s Crunch Time for Cash Flow and Closures. What’s on the Other Side?

Pharmacy Times

With worsening news from accounting, where does community pharmacy go from here?

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AlphaFold 3 takes structure predictions well beyond proteins

pharmaphorum

Google DeepMind and Isomorphic Labs' newly launched AlphaFold 3 extends the power of the AI model to 'all life’s molecules'

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Can you drink coffee while taking amoxicillin?

The Checkup by Singlecare

Amoxicillin , an antibiotic in the penicillin family, is commonly prescribed to treat a variety of bacterial infections, such as ear infections, pneumonia, strep throat, and urinary tract infections. It’s a broad-spectrum treatment that works by breaking down the walls that shield bacteria, neutralizing their ability to grow and spread, and allowing your immune system to clear infections.

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Community Health Systems adds another antitrust lawsuit to MultiPlan's collection

Fierce Healthcare

Community Health Systems (CHS) is the latest health system to allege that MultiPlan’s data-driven claims repricing business meets the bar for antitrust violation. | CHS is the third health system to allege that MultiPlan's claims repricing business and deals with major payers are anticompetitive.

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In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

Fierce Pharma

Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuti | Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuticals and CRISPR Therapeutics?

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Quiz: Understanding Allergy and Asthma Clinical Guidelines

Drug Topics

Test your knowledge of allergy and asthma clinical guidelines.

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Pfizer puts 74 Swiss jobs on chopping block as it folds Seagen into its cancer operations

Fierce Pharma

After telegraphing more than a hundred potential layoffs in March in connection with plans to stop construction of a massive Seagen facility, Pfizer is plowing ahead with efforts to streamline its | Pfizer has proposed another round of staff reductions and role changes at legacy Seagen, this time hitting Seagen’s European headquarters in Switzerland, where 74 positions could be up for the chop.

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