Fri.Sep 15, 2023

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Expert: Artificial Intelligence Changing the Field of Medical Writing

Pharmacy Times

The CEO of Yseop discusses how AI can have a positive impact in the development of high quality medical writing due to its efficiency and ability to reduce long, tedious tasks for writers.

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Polio transmission was supposed to end by 2023. A new report explains why it won’t.

STAT

The latest goal for the end of polio transmission will almost certainly not be met, according to a frank and concerning report about the future of the decades-long polio eradication effort that was released this week. After having missed multiple deadlines for ending polio transmission, the Global Polio Eradication Initiative had set 2023 as the year when both wild polio viruses would finally be snuffed out and so-called vaccine-derived viruses would also be stopped, putting an end to a family o

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Clinical Overview: Fecal Microbiota Transplantation vs Live Biotherapeutic Products for Management of Recurrent C Difficile Infection

Pharmacy Times

Although antibiotics are the standard-of-care treatment for Clostridioides difficile infection, they can cause further microbiota changes that predispose patients to recurrence.

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Randomized controlled trials are the ‘gold standard’ of research — but a difficult fit for trans care

STAT

In order to provide gender-affirming care, clinicians must sometimes jump through unusual hoops. In Australia, for example, the government won’t subsidize testosterone treatment for a trans man without a peculiar bureaucratic maneuver; a doctor must say the patient has a testicular disorder. The disorder: Trans men, being trans, are born without testes.

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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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Ensuring Health Equity in Vaccination Access: How Pharmacies Can Work With Community Organizations

Pharmacy Times

Community pharmacies and organizations can collaborate to tailor strategies and interventions and address the challenges and specific needs of the community.

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Opinion: How the Wegovy shortage is making life impossible for my patients — and for me

STAT

There is just not enough Wegovy. The current manufacturing shortage will eventually end, and those who have health insurance that covers Wegovy, plus the even luckier ones who can afford to pay out of pocket, will once again get their medication.

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Opinion: The morally ground-shifting legacy of Ian Wilmut and Dolly the sheep

STAT

Ian Wilmut, the British scientist behind the first-ever cloning of a mammal, died Sept. 10, leaving behind a twofold legacy. One part is groundbreaking science. Creating Dolly required a combination of genome manipulation and reproductive tools that helped launch what is sometimes called “ reprogenetics ,” a basket of reproductive and genetic technologies that allow for greater control over human procreation and generated work that ranges from human-animal chimeras to the “d

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Kroger Health teams up with meal delivery company on medically tailored meals for chronic conditions

Fierce Healthcare

Kroger Health, part of the Kroger Co., is teaming up with Performance Kitchen to offer medically tailored meals to people with chronic conditions. | Performance Kitchen’s team of chefs, doctors and registered dietitians focuses on delivering nutritionally balanced meals. The meals will be both approved by Performance Kitchen’s team and Kroger Health registered dietitians.

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Moderna's mRNA Flu Vaccine Shows Positive Results in Phase 3 Trial

Drug Topics

The mRNA-1010 vaccine generated a powerful response against 4 influenza virus strains compared to traditional flu shots.

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Ascension wraps the year with $2.7B loss thanks to higher expenses, one-time impairment loss

Fierce Healthcare

Ascension closed out its 2023 fiscal year with a $2.66 billion net loss, according to financial disclosures for the period ended June 30. | Discarding a $1.5 billion one-time write-down still left the Catholic giant with a $1.55 billion loss from recurring operations.

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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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MDMA-Assisted Therapy Demonstrates Significant Reductions in Post-Traumatic Stress Disorder Symptoms in Phase 3 Study

Pharmacy Times

Study results could lead to an FDA approval for MDMA to treat post-traumatic stress disorder by the end of 2023.

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Priority Health launches program to back placement of service dogs in schools

Fierce Healthcare

Worsening mental health among young people is a growing national concern, and, in a bid to tackle the issue in its home state of Michigan, insurer Priority Health is going to the dogs—literally.

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Advanced Hybrid Closed-Loop Technology Could Improve Quality of Life in Type 1 Diabetes

Drug Topics

A 1-year observational follow-up of a 3-month randomized controlled trial provides insight into the benefits of advanced hybrid closed-loop system use in people with type 1 diabetes using multiple daily injections and self-monitoring of blood glucose.

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Industry Voices—Medical debt isn't about money. It's about health

Fierce Healthcare

There is no shortage of unjust elements in the U.S. healthcare system. But one in particular deserves far more attention and action than it is currently receiving—namely, medical debt. | As healthcare leaders, we believe there is a moral obligation to take action to reduce the burden of medical debt, and there are obvious levers to help.

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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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J&J, GSK and other companies knowingly marketed ineffective decongestants, lawsuits claim

Fierce Pharma

Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.

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STAT+: South Africa investigates Johnson & Johnson over ‘excessive pricing’ for its TB drug

STAT

South African authorities are investigating Johnson & Johnson and its Janssen subsidiary over “excessive pricing” of a lifesaving tuberculosis drug, the latest imbroglio to engulf the company of its medicine. In a brief statement , the South African Competition Commission confirmed that it lodged a complaint earlier this week against the health care giant over its TB medicine, bedaquiline , which is also sold under the Sirturo brand name.

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Experts Predict Multiple Myeloma Outcomes Will Improve With Greater Use of Bispecific Antibodies

Pharmacy Times

Bispecific antibodies have 2 distinct binding domains, which interact with either CD3 on T cells or a tumor-associated antigen on the tumor cell surface.

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GSK and Save the Children extend partnership for unvaccinated children

Pharmafile

GSK and Save the Children have announced that they will be renewing their partnership for an additional five years. GSK plans to invest £15m in the partnership, with the two companies working together to increase rates of childhood vaccination. The partnership aims to reduce the number of ‘zero dose’ children in Ethiopia and Nigeria, meaning […] The post GSK and Save the Children extend partnership for unvaccinated children appeared first on Pharmafile.

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Small molecule drug shows promise in rare disease

European Pharmaceutical Review

The CBL-0201DD Phase II study evaluating the first-in-class small-molecule drug CBL-514 for Dercum’s disease, a rare disorder, has demonstrated significant efficacy in reducing lipoma size and complete clearance. Dercum’s disease is characterised by painful lipomas developing primarily on the trunk in the body. Currently there are no approved or effective medicine, so the data from the Phase II study shows potential of a treatment for this indication.

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Diabetes Guidelines for Pediatric Patients Updated by ADA

Drug Topics

The American Diabetes Association's 2023 “Children and adolescents: standards of care in diabetes” highlights risk factors and treatment for type 1 and type 2 diabetes.

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Bayer CEO plots management cuts as first step in larger overhaul: Reuters

Fierce Pharma

Just a few months into Bill Anderson's tenure as Bayer's CEO, the helmsman is reportedly looking to trim the drugmaker's management ranks. | The CEO is eying some big changes, but he wants to show investors he's prepared to act swiftly, Reuters reports. The publication cited three people "familiar with the matter" in reporting the behind-the-scenes developments at Bayer.

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Miebo, First Prescription Eye Drop to Treat Tear Evaporation in Dry Eye Disease, Now Available

Drug Topics

The perfluorohexyloctane ophthalmic solution from Bausch + Lomb was approved by the FDA in May and will have a whole acquisition cost of $771 for a one-month supply.

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Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Fierce Pharma

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophreni | Lyndra Therapeutics is laying off staff two months after a CEO swap and as interim data from a pivotal trial for a schizophrenia drug nears. The company's lead asset is a long-acting, oral version of Johnson & Johnson's Uzedy.

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Orforglipron Associated With Significant Weight Loss

Pharmacy Times

As a once-daily oral treatment, orforglipron could help address barriers to injectable medications, such as semaglutide and liraglutide.

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Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

Fierce Pharma

With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of | With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of weighty patent losses.

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Can antibiotics cause diarrhea?

The Checkup by Singlecare

If you have ever gone to the doctor for an infection, you have probably been prescribed antibiotic treatment. These medications are formulated to kill harmful bacteria that cause infections, and like most medications, antibiotics come with a risk of side effects. One of the most common complaints is antibiotic-induced diarrhea. Generally, diarrhea clears up after you stop taking the antibiotics.

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After FDA setback, PTC Therapeutics' DMD drug Translarna faces possible market withdrawal in Europe

Fierce Pharma

A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review. | A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review.

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Experts Discuss Updates In COVID-19 Immunization

Pharmacy Times

Expert panelists addressed concerns about the COVID-19 vaccine costs, availability, efficacy, and timing.

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Michigan Blues chief announces retirement day after 1K workers go on strike

Fierce Healthcare

There’s been a lot of churn at Blue Cross Blue Shield of Michigan (BCBSM) this week. | Daniel J. Loepp, the president and CEO of Blue Cross Blue Shield of Michigan, announced his departure date the day after workers at the insurer went on strike.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Health subcommittee members at odds over drafted drug shortage legislation

Fierce Healthcare

The U.S. | Experts were brought to the hill to explain the root causes of drug shortages, plus how potential legislation could remedy the problem.

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Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities

ISPE

Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities Trudy Patterson Fri, 09/15/2023 - 11:28 iSpeak Blog iSpeak Regulatory, Compliance and Quality Challenges, Learnings, and Future Opportunities Connie Langer Ciby Abraham, PhD 15 September 2023 The pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally.

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Janssen rebrands its identity

European Pharmaceutical Review

The Janssen Pharmaceutical Companies of Johnson & Johnson has changed its name to Johnson & Johnson Innovative Medicine (J&J Innovative Medicine). Johnson & Johnson is bringing together its divisions under the J&J brand name. While Janssen, J&J’s pharmaceutical division will be known as J&J Innovative Medicine, the company’s medical technology segment will continue to be named Johnson & Johnson MedTech.

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The Promise of Biosimilars Is Within Reach for Health Systems

Pharmacy Times

A collaborative exercise with 16 health care organizations nets millions in savings.

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