Mon.Mar 04, 2024

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Disparities in Digital Health Portal Use Persist Beyond the COVID-19 Pandemic

Drug Topics

Although the pandemic spurred a greater need and use of online health resources, certain demographics continue to report significantly low participation in digital health portals.

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Covid-19 increases risk of developing autoimmune disease, but vaccination helps, large study shows

STAT

Having Covid-19 increases a person’s risk of developing an autoimmune disease in the year after infection, a large study out of South Korea and Japan reports, but vaccination helps decrease that risk. Researchers used the medical records of 10 million Korean and 12 million Japanese adults to see whether those who had Covid were more likely to be diagnosed with autoimmune inflammatory rheumatic diseases, or AIRDs, in the year following infection.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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STAT+: Explaining Change Healthcare and the gravity of its cyberattack

STAT

The cyberattack on Change Healthcare has fractured the country’s health care payment infrastructure. But it also exposed how complicated and vital these electronic pipes are. Using terms like “clearinghouse” and “electronic data interchange” are quick ways to lose an audience. But Ben Handel, a health economist at the University of California, Berkeley, for the past 13 years, has become intimately familiar with that language.

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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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Mark Cuban says Cost Plus Drugs targeting generic meds in short supply as it opens manufacturing facility

Fierce Healthcare

Mark Cuban Cost Plus Drugs Company will begin manufacturing its own generic medications this week, starting with sterile injectables, founder and CEO Dr. | Mark Cuban Cost Plus Drugs Company will begin manufacturing its own generic medications this week, starting with sterile injectables, founder and CEO Dr. Alex Oshmyansky said Monday during a White House roundtable on lowering healthcare costs.

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In a first, fetal cell organoids generated from amniotic fluid, new study reports

STAT

As a fetus develops, its body is bathed in amniotic fluid: a warm, salty soup of nutrients, hormones, and antibodies produced by its mother. And into that fluid, a fetus is constantly sloughing off or peeing out cells, which provide genetic material that doctors can pull out with a needle and examine for signs of disease in a process called amniocentesis.

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STAT+: White House is told the big three PBMs are ‘everything wrong with this industry’

STAT

As part of its battle to blunt the growing cost of medicines, the White House on Monday held a so-called listening session in hopes of finding ways to rein in big pharmacy benefit managers, which occupy an opaque but crucial role in pharmaceutical pricing in the U.S. The gathering resembled something of a fact-finding mission as a small group of policymakers and business people briefly shared their experiences dealing with the largest industry middlemen, who negotiate with drugmakers on behalf o

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Change's temporary funding program 'not even a Band-Aid,' AHA president says, as White House reportedly mulls financial relief

Fierce Healthcare

Change's temporary funding program 'not even a Band-Aid,' AHA president says, as White House reportedly mulls financial relief agliadkovskaya Mon, 03/04/2024 - 14:07

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STAT+: Federal regulators, scrambling to keep up with AI in health care, team up with industry to set standards

STAT

At first glance, the Coalition for Health AI looks like any technology lobbying group. Its membership — including Microsoft, Google, and many of the nation’s largest academic hospitals — forms a formidable presence in Washington. But on Monday, the coalition forged a different deal with federal regulators. It will work with them to develop quality and safety standards for artificial intelligence, an experiment that will test whether industry and government can effectively pa

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Congress reaches spending deal with doc pay bump, delayed DSH cuts and more

Fierce Healthcare

A bipartisan spending bill unveiled Sunday narrows some of this year’s cuts to physician Medicare pay, pushes back scheduled disproportionate share hospital (DSH) payment cuts and increases annual | A 1,050-page bill unveiled Sunday included several key lobbying focuses for providers but excludes other hot-button topics like potential pharmacy benefit manager and ghost network regulations "until December or longer.

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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+: Medicare is a tricky market for telehealth companies. Why is Talkspace betting on it?

STAT

Over the last few years, virtual mental health company Talkspace has been on a relentless quest to conquer the insurance market. The next step in that journey, Medicare, may prove the most challenging yet. Talkspace’s pivot away from its direct-to-consumer roots has so far been a success. The company claims its 130 million people have access to its services through deals with  insurers, employers, or through other arrangements, and it is now knocking on the door of profitability 

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Opioid use disorder treatment retention improves with insurance coverage: study

Fierce Healthcare

Insurance network coverage dramatically impacts whether a person remains in treatment for opioid use disorder, according to results shared by treatment provider Ophelia. | In-network insurance coverage goes a long way in making sure individuals continue opioid use disorder treatment, according to a study out of Health Affairs.

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STAT+: Longer treatment gave better liver outcomes for MASH patients, Akero drug study shows

STAT

Akero Therapeutics said Monday that extending treatment with its experimental drug for the liver disease known as MASH from six months to two years resulted in better outcomes for patients — most notably reductions in liver scarring at a rate three times higher than placebo without worsening other symptoms. The mid-stage study of the Akero drug called efruxifermin achieved its main goal in September 2022.

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Chartis: A look at Medicare Advantage enrollment trends in 2024

Fierce Healthcare

Medicare Advantage (MA) growth has broadly slowed, but the biggest players in this space continue to claim the lion's share of this expansion, according to a new report from healthcare consultant C | Medicare Advantage growth has broadly slowed, but the biggest players in this space continue to claim the lion's share of this expansion, according to a new report from healthcare consultants Chartis.

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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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Opinion: Missing data is making it difficult for the pharmaceutical industry to help LGBTQ+ people

STAT

Lack of health data on LGBTQ+ people has real-world consequences. A participant in a 2020 report from the National LGBT Cancer Network said: “There are no guidelines for cancers that are more prevalent among Trans women. I had to fight like hell to have an anoscopy, and sure enough we found [precancerous lesions]!” That same year, the National Academies of Sciences, Engineering, and Medicine issued a hallmark report  on the health and well-being of LGBTQ+ people.

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COVID-19 Vaccine Timing May Affect Menstrual Cycle Length

Drug Topics

Study findings clarifying what to expect regarding the menstrual cycle after COVID-19 vaccination could help address low vaccine uptake.

Vaccines 112
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Perrigo's over-the-counter birth control launch takes flight in the US

Fierce Pharma

A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.” | A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.

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Dupilumab Safe, Effective for Atopic Dermatitis in Real-Life Settings

Drug Topics

In 2017, dupilumab became the first treatment approved in Canada for moderate to severe AD, as multiple clinical trials demonstrated its effectiveness and safety.

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RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

Fierce Pharma

After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness. | After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

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Industry Voices—Code blue: Rescuing America's healthcare system by bolstering the workforce pipeline

Fierce Healthcare

Unless the U.S. attracts more nurses and allied health professionals into the workforce, our healthcare system will soon face catastrophic consequences. | Unless the U.S. attracts more nurses and allied health professionals into the workforce, our healthcare system will soon face catastrophic consequences.

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Dark factories for a bright future

pharmaphorum

Explore the future of drug manufacturing with dark factories, robotic and automated facilities that promise efficiency and innovation. Learn how these advancements are shaping a bright future for the pharmaceutical industry.

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STAT+: ‘It’s a nightmare’: One of the most common children’s asthma meds is no longer available, leaving families scrambling

STAT

A commonly prescribed medication for children’s asthma is disappearing from pharmacists’ shelves, forcing parents and pediatricians to scramble for alternatives just as  allergy seaso n  is about to start. In a move unusual for such a widely used drug, GlaxoSmithKline discontinued Flovent HFA, the brand name of its corticosteroid treatment fluticasone propionate, at the end of December.

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EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

pharmaphorum

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan in breast and lung cancer. The EMA has validated the two parallel applications for the drug, also known as Dato-DXd, in adults with previously treated non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer.

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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

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FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment

Pharmafile

Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority review. The drug has been approved in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 […] The post FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment appe

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After multiple wrist-slaps, Aurobindo unit Eugia receives another manufacturing write-up

Fierce Pharma

Aurobindo subsidiary Eugia is back in hot water with the FDA after a recent plant inspection yielded yet another Form 483—this time in India. | Following an inspection of Eugia's injectables facility in Telangana, India, the FDA issued a formal rebuke laying out seven manufacturing observations, parent company Aurobindo said in a recent filing.

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First over-the-counter birth control pill in U.S. begins shipping to stores

STAT

WASHINGTON — The first over-the-counter birth control pill  will be available in U.S. stores later this month, allowing American women and teens to purchase contraceptive medication as easily as they buy aspirin. Manufacturer Perrigo said Monday it has begun shipping the medication, Opill , to major retailers and pharmacies. A one-month supply will cost about $20 and a three-month supply will cost around $50, according to the company’s suggested retail price.

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With Takeda out of the picture, J&J’s Rybrevant moves into first line in lung cancer subtype

Fierce Pharma

Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients. | Johnson & Johnson continues to grow its oncology franchise with a new FDA approval that opens the lung cancer drug Rybrevant to treating certain newly diagnosed patients.

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STAT+: He’s 19 months old and has one of the world’s rarest diseases. His parents are determined to find a cure.

STAT

SOMERVILLE — At 19 months old, Lucas Guo has never crawled, walked, or stood by himself. He babbles but can’t say words. He struggles to chew and swallow. He gets most of his nutrition through a feeding tube attached to his belly. Lucas has one of the world’s rarest diseases, ZTTK syndrome, a complex neurological disorder caused by a genetic mutation.

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Judge dismisses NYU Langone's 'confusing and expansive' claims that Northwell copied its purple ads

Fierce Healthcare

A federal judge handed Northwell Health a victory in a lawsuit with NYU Langone Health System over allegations that advertisements run by the former intentionally emulated the visuals and color pal | A federal judge faulted NYU Langone Health for its lack of specificity when arguing that competitor Northwell Health "intentionally" copied its advertising style.

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Serum Institute of India wants government HPV contract

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! A thought: I moved to San Diego last year and am always on the lookout for interesting news. If you’re here, reach out! In today’s newsletter, we discuss embryonic stem cell ethics, learn of parents searching for a treatment for their son’s ultra-rare neurological disease, and more.

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Watch DSN: Kroger Health tackles holistic health

Drug Store News

Dr. Marc Watkins, chief medical officer of Kroger Health, discusses how the company is looking to tackle holistic health—and more importantly how food is medicine.

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STAT+: Pharmalittle: We’re reading about a nixed Medicare negotiation lawsuit, an Obamacare challenge, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup of stimulation.

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Tutch brings digital platform to U.S. retailers

Drug Store News

Tutch is displayed on interactive screens or digital devices throughout stores, providing shoppers access to retailers’ entire inventories.

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