Wed.Dec 13, 2023

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MAPS Submits NDA for First-Ever Psychedelic-Assisted Therapy for PTSD

Drug Topics

Despite affecting 13 million Americans annually, existing post-traumatic stress disorder (PTSD) treatments offer modest relief and more effective approaches are needed.

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Tirzepatide Results in Superior Mean Percent Change in Body Weight for Those with Obesity

Pharmacy Times

In the phase 3 SURMOUNT-4 trial, investigators included individuals with at least 1 weight-related complication, including hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

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Understanding Adverse Events With BCMA-, Non-BCMA-Targeting Bispecific Antibodies in Multiple Myeloma

Drug Topics

Understanding the adverse event profile of bispecific antibodies can aid treatment selection and improve patient outcomes.

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Gene therapy offered this 7-year-old freedom. The price: a grueling year

STAT

PHILADELPHIA — The meds Shelby Campbell needed for her rare blood disorder stopped working just after her sixth birthday. She lost her appetite and was often doubled over in pain. She continued getting blood transfusions but her doctors struggled to manage side effects that threatened her organs. By the time she turned 7, the doctors told her parents they had to do something — soon.

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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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Daratumumab Plus VRd Improves Progression Free Survival in Newly Diagnosed Multiple Myeloma

Drug Topics

Results of the phase 3 PERSEUS study were presented at the 2023 ASH Annual Meeting and Exposition.

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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

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Class action lawsuit accuses Humana of using AI algorithms to restrict access to care

Fierce Healthcare

A newly filed lawsuit alleges that Humana used artificial intelligence algorithms to deny key rehabilitation care for seniors. | A newly filed lawsuit alleges that Humana used artificial intelligence algorithms to deny key rehabilitation care for seniors.

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STAT+: New federal rules demand transparency into AI models used in health decisions

STAT

Federal health technology regulators on Wednesday finalized new rules to force software vendors to disclose how artificial intelligence tools are trained, developed, and tested — a move to protect patients against biased and harmful decisions about their care. The rules are aimed at placing guardrails around a new generation of AI models gaining rapid adoption in hospitals and clinics around the country.

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'It can be life or death': Microsoft's Peter Lee on the power, dangers of GPT-4 in medicine

Fierce Healthcare

Addressing a room of healthcare professionals at the IHI Forum on Wednesday, Peter Lee, corporate vice president of research and incubations at Microsoft, opened by saying the audience was possibly | It is wrong to think of large language models like GPT-4 as traditional computers—they are reasoning engines and can make mistakes like humans do, the tech giant's corporate vice president of research and incubations warned IHI Forum attendees.

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Doctors call out ableism in cancer care: ‘The biggest accommodation is attitude’

STAT

People with disabilities often spend a lot of time navigating bias and educating others about their condition. When it comes to cancer, assumptions made by their doctors can undermine their care even before it starts. The potential for pitfalls is vast. Clinicians might assume a woman who uses a wheelchair isn’t sexually active so doesn’t need to be tested for HPV, the virus that causes cervical cancer.

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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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Payers' increasing claims denials, delays 'wreaking havoc' on provider revenue cycles

Fierce Healthcare

A jump in claim delays and denials is “wreaking havoc on providers’ revenue cycle performance” and contributing to health systems’ “volatile” accounts receivable and diminishing cash reserves, acco | More frequent pushback from commercial and Medicare Advantage payers is complicating patient self-pay collections and, ultimately, undermining the revenues and cash reserves of hospitals, health systems and physician groups, according to a pair of recent reports.

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Opinion: Exceptions to abortion restrictions often fail people like Kate Cox whose babies are sure to die

STAT

Imagine being in the midst of your pregnancy, and you learn that your baby is unlikely to live for more than a few fleeting moments after birth. There is no cure for their condition. Nothing can prevent their death. Most people think they will never be in such a situation. And most people are right. But Kate Cox’s case in Texas this week serves as a stark wake-up call to the nation: This could happen to you or someone you care about, and medical exceptions to anti-abortion laws won’

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Researchers Find Similar Immune Response in Half-Dose COVID-19 Vaccine as Full-Dose

Pharmacy Times

Fractional COVID-19 dosing resulted in fewer adverse effects and costs while producing similar immune responses compared to a full dose vaccine.

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STAT+: After decade-long dispute over CRISPR-Cas9, Editas strikes deal with Vertex to cash in

STAT

For a decade, leading academic institutes and their associated companies fought a bruising, headline-grabbing fight over who held patent rights to CRISPR-Cas9, the revolutionary genome editing tool. Editas Medicine, the winner of that battle in the U.S., will now cash in. Vertex Pharmaceuticals and Editas announced Wednesday that Vertex will pay Editas $50 million, along with a series of annual payments through 2034, in exchange for rights to use CRISPR-Cas9 in Casgevy , the sickle cell therapy

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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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HHS finalizes rule to move the needle on interoperability, algorithm transparency

Fierce Healthcare

The federal government's healthcare tech arm finalized a sweeping regulation that requires new technology upgrades while also advancing interoperability and transparency in predictive decision supp | The federal government's healthcare tech arm finalized a sweeping regulation that requires new technology upgrades while also advancing interoperability and transparency in predictive decision support tools.

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Disparities Across European NEAT ID Centers Impact Implementation, Roll-Out of PrEP

Pharmacy Times

Both individual and structural barriers were the most common hindrances to PrEP roll-out, and the investigators emphasize that efforts to remove the obstacles as well as further research can help improve PrEP implementation.

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What to eat when you have a sore throat

The Checkup by Singlecare

Dealing with a sore throat can be a real pain—literally. When your throat is raw and inflamed, you may be enticed by cold foods like ice cream or smoothies. And while certain things may feel good on the throat, not all foods will help you heal. No matter what’s causing your sore throat, nourishing your body with healthy food sources is essential to getting better.

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STAT+: Vertex non-opioid drug reduces chronic nerve pain in mid-stage study

STAT

Vertex Pharmaceuticals said Wednesday that an experimental drug reduced pain in people with diabetes who have chronic nerve pain — mid-stage study results that support the biotech company’s efforts to develop an effective painkiller without the addictive potential of opioids. The drug, a pill called VX-548, is designed to precisely block pain-sensing neurons from signaling the brain.

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The Importance of Continuing Education in Pharmacy Compounding

Drug Topics

Kevin Hope, RPh, senior director of pharmacy education at Pharmcon, joined Drug Topics to discuss pharmacy compounding from the new USP changes and the importance of education around compounding best practices.

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Opinion: Sobering centers offer a safe place to recover from intoxication. Every community should have one

STAT

Every day, thousands of individuals across the United States call 911 due to concern about someone who is intoxicated in public. Their concern is warranted: The potential harms from public intoxication are significant. They are at risk of being the target of assault, violence, or theft or may suffer injury or death from an underlying health condition.

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Virtual doula care improves outcomes on par with in-person care, Maven study finds

Fierce Healthcare

Virtual doula care improves birth experiences and reduces the odds of a cesarean section at rates comparable to in-person doula care, a new study finds. | The odds of a C-section decreased notably with several doula visits on the Maven platform, and more so for Black members.

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Opinion: Listen: When do tests hurt more than help?

STAT

Manil Suri and Daniel Morgan are an unusual team: Manil is a mathematics professor and author (of both fiction and nonfiction ), while Daniel is a physician and professor of epidemiology, public health, and infectious diseases. But — in what they say is a typical “Smalltimore” moment — both a neighbor and a student had told them they should work together because of a shared interest in false positives on diagnostics tests.

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FDA Approves IVIG for Pediatric Patients Aged 2 and Older With Primary Humoral Immunodeficiency

Pharmacy Times

Bivigam was initially approved by the FDA in May 2019 for the treatment of primary humoral immunodeficiency, including a group of genetic disorders.

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STAT+: Pfizer says 2024 profits will fall far below expectations

STAT

Pfizer said Wednesday that its 2024 profits would fall far below investor expectations, leading shares to tumble 7% in early trading. The reduced earnings numbers cap a difficult year for the drug giant. Its shares have fallen 45% and it has struggled to maintain the momentum it achieved during the pandemic with the development of one of two widely used Covid vaccines and a Covid treatment, Paxlovid.

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Finding that Spark

PharmExec

Lisa Conte, founder, president, and CEO of Jaguar Health, discusses how a climb up Mount Kilimanjaro would vault her to her true career calling—and spark a decades-long quest to accelerate breakthroughs in plant-based pharmaceuticals and supportive care.

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Supreme Court will decide abortion pill access

STAT

WASHINGTON — The Supreme Court agreed Wednesday to take on whether Americans can access a commonly used abortion pill. It will be the court’s first major abortion case since it overturned Roe v. Wade last year, giving jurisdiction over abortion laws back to the states. Since then, 13 states have banned the procedure and seven others have enacted severe limits, though several of those restrictions are in court and voters have spurned others.

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Back to normal? Health care spending growth rates down from pandemic era

Fierce Healthcare

Healthcare spending has increased 4.1% to $4.5 trillion, or $13,493 per person, according to a new report from the Centers for Medicare & Medicaid Services published in Health Affairs. | Health care spending increased to $4.5 trillion in 2022, or $13,493. Here's how that breaks down.

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STAT+: Bankrupt Pear’s addiction treatments acquired by virtual care company

STAT

Half a year after selling its assets at bankruptcy auction , Pear Therapeutics’ most significant digital treatments will find a new life as part of PursueCare, which provides online addiction care and mental health counseling. PursueCare today announced it had raised a $20 million Series B round and that it had acquired Pear’s portfolio of apps that treat people with addiction problems.

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After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

Fierce Pharma

After last year’s explosive ruling to overturn the historic abortion ruling reached in Roe v. Wade, abortion access is back up for debate in the Supreme Court. | The Supreme Court's final decision could have consequences beyond abortion access. That's because the original verdict questioned the FDA's decision-making authority, prompting amicus brief submissions from high-profile industry players.

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STAT+: Could sickle cell someday be treated not with CRISPR, but with a pill?

STAT

Two gene therapies were approved for sickle cell disease last week, but for many researchers the Holy Grail remains something far more modest: A pill. Only the pharmacists’ oldest tool, they say, can actually have an impact on the scale of sickle cell. The gene therapies, with the risks and hospital stays and bespoke manufacturing they entail, won’t be an option for the vast majority of U.S. patients or for virtually any of the 20 million patients across the Global South.

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Researchers Find Allergy Medication Could Aid Treatment for Lung Cancer

Pharmacy Times

Immune cells in lung cancer are connected to allergic conditions found in eczema and asthma.

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A plot to solve the ‘whack-a-mole’ of drug discovery

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, everyone. Damian here with some hotly anticipated news from Vertex Pharmaceuticals, a closer look at the latest FTC controversy, and a detailed look at what it’s like to actually receive a gene therapy.

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Kroger, Instacart broaden SNAP partnership

Drug Store News

Instacart expanded its partnership with the retailer to enable digital SNAP acceptance at all Kroger, Ralphs, Foods Co, Fry’s, Jay C, Pay Less and Food 4 Less stores on its platform.

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STAT+: Pharmalittle: Employers hire virtual providers as obesity drug gatekeepers; Vertex non-opioid nerve pain drug succeeds in mid-stage trial

STAT

Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation.

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