Tue.Oct 31, 2023

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Pfizer, BioNTech Release Positive Topline Data for Combination COVID-19/Flu Vaccine

Drug Topics

The combination vaccine produced robust immune responses from vaccine candidates in a phase 1/2 clinical trial.

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Second recipient of genetically modified pig heart dies, six weeks after surgery

STAT

Nearly six weeks after his surgery, the world’s second recipient of a genetically modified pig heart has died, the University of Maryland announced Tuesday. Lawrence Faucette, a 58-year-old resident of Frederick, Md., with terminal heart disease, died Monday. He had received the experimental xenotransplant on September 20 at the University of Maryland Medical Center in an eight-hour operation.

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As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty

Fierce Pharma

For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.

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Opinion: I lost my son to OxyContin. ‘The Fall of the House of Usher’ is my Sackler revenge fantasy

STAT

Editor’s note: This essay contains spoilers for the Netflix show “The Fall of the House of Usher.” “W atch “ The Fall of the House of Usher” on Netflix when you can. F**cking Great! Totally based on the Sacklers—Fictional obviously but so damn good!

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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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Physical Activity Positively Impacts Symptoms of Depression, Anxiety

Pharmacy Times

Modern society has put individuals at an increased risk of dopamine overload, causing an increase in mental health disorders.

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STAT+: Tracking the FDA advisory panel on the first CRISPR-based treatment for sickle cell disease

STAT

The Food and Drug Administration is convening a meeting of outside experts on Tuesday to review exa-cel, a CRISPR-based treatment for sickle cell disease made by Vertex Pharmaceuticals and CRISPR Therapeutics. Tuesday’s meeting is set up a bit differently than most FDA advisory panels. The agency has not raised any concerns about exa-cel’s efficacy or safety, and there will not be a typical vote at the end of the day on whether the data from exa-cel’s pivotal clinical trial

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More Trending

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STAT+: Eli Lilly to pay $200 million for Beam’s share of drugs from gene-editing firm Verve

STAT

Eli Lilly said Tuesday that it will pay $200 million to gene-editing firm Beam Therapeutics for Beam’s stake in Verve Therapeutics, another gene-editing company focused on treatments for heart disease. The deal, which also includes future milestone payments, is evidence that despite the pressure on biotechnology stocks there is still interest in very early cutting-edge technologies among big pharmaceutical players.

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FDA Approves sBLA for Abatacept in the Treatment of Juvenile Psoriatic Arthritis

Pharmacy Times

The approval is supported by safety data from clinical trials assessing abatacept in the treatment of patients aged 2 to 17 with psoriatic arthritis.

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STAT+: DeepMind touts AlphaFold’s new skills as protein-folding AI models face off

STAT

On Tuesday, Google DeepMind and Isomorphic Labs announced a significant progress update on the next iteration of AlphaFold, the deep learning model that in 2020 cracked the problem of predicting a protein’s structure from its amino acid sequence, leapfrogging other approaches in computational biology. Now, the companies say they have developed the model to predict not just standalone protein structures, but what proteins look like in combination with several classes of molecules, includin

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Review Treatment Options for Insomnia

Pharmacy Times

According to 2020 data from the CDC, about 14.5% of adults reported having trouble falling asleep most or every day during the 30 days prior to the survey.

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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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How skeptical should you be of an after-the-fact subgroup analysis in a failed clinical trial?

STAT

This article was adapted from STAT’s latest report , “Subgroup analysis: how to evaluate post hoc tests for significance in failed clinical trials.” C linical trials of newly developed drugs often don’t work out.

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Cleveland Clinic to launch prescription delivery via drone in 2025, starting with specialty and rush medications

Fierce Healthcare

Cleveland Clinic plans to launch a drone delivery service to bring certain medications directly to patients’ homes, starting in 2025. | Cleveland Clinic plans to launch a drone delivery service to bring certain medications directly to patients’ homes, starting in 2025.

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New CDC campaign asks health care leaders to take responsibility for reducing burnout

STAT

Often, workplace conversations about burnout put the onus on the individual to take care of their mental health while ignoring management’s role in solving the problem. A new anti-burnout campaign from the Centers for Disease Control and National Institute for Occupational Safety and Health avoids this typical — and often frustrating — tactic, instead imploring leaders to better support health care workers.

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CDC releases free tools for hospitals to address their workers' mental health

Fierce Healthcare

The Centers for Disease Control and Prevention (CDC) has launched the first-ever federal campaign encouraging hospitals to track and address burnout across their workforces. | Included among the Impact Wellbeing campaign’s free offerings are a wellbeing questionnaire, a leadership storytelling guide and a toolkit for removing mental health questions from a hospital's credentialing applications.

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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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La ‘paradoja hispana’ intriga a una nueva generación de investigadores decididos a resolverla

STAT

Read in English | Leer en inglés. D urante 40 años, los investigadores han intentado sin éxito explicar –o desacreditar– la “paradoja hispana”, es decir, la constatación de que los hispanoamericanos viven varios años más que los estadounidenses blancos por término medio, a pesar de disponer de ingresos y atención sanitaria mucho menores, y mayores tasas de diabetes y obesidad.

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Battling new rivals and bracing for Jakafi's patent cliff, Incyte shores up growth plan

Fierce Pharma

As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff. | As several new JAK inhibitors threaten Incyte’s bread-and-butter Jakafi in myelofibrosis, the company is busy advancing new regimens ahead of the drug’s 2028 patent cliff.

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STAT+: Medicare is urged to consider Amgen patent maneuvers when negotiating the price for a drug

STAT

As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026. At issue is the Enbrel medication sold by Amgen for treating rheumatoid arthritis and other ailments.

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Health Care Workers Can be Part of the Climate Change Solution

Drug Topics

Anesthetic gases and meter dose inhalers, how we use our antibiotics, how we use our resources for infection prevention and control, and how we use plastic and food in our hospitals all add up.

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Nearly a quarter of hospital stent procedures are unnecessary, fueling billions in low-value spending, Lown Institute finds

Fierce Healthcare

Nearly a quarter of hospital stent procedures are unnecessary, fueling billions in low-value spending, Lown Institute finds dmuoio Tue, 10/31/2023 - 14:33

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Galapagos plans to cut 100 jobs after striking deal to transfer Jyseleca, 400 staffers to Alfasigma

Fierce Pharma

For 170 million euros plus royalties, Galapagos has transferred Jyseleca and its operations to Alfasigma. The deal includes 400 employees who will transfer to Alfasigma.

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Opinion: Health care providers need help to treat patients during extreme heat events

STAT

The world’s hottest summer on record is now bleeding into the fall. Instead of enjoying a cool respite from the heat, millions of Americans started September enduring temperatures so high that schools were forced to close across the country. Extreme heat continued into October, leading organizers to cancel the Twin Cities Marathon due to a forecasted high of 91 degrees — 25 degrees higher than normal for Minneapolis and St.

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With Tepezza sales still stagnant, Amgen has a plan to boost the newly acquired TED drug

Fierce Pharma

As Amgen’s $27.8 billion buyout of Horizon Therapeutics became official earlier this month, one of the first orders of business for the California biotech giant was to get acquired blockbuster Tepe | As Amgen’s $27.8 billion buyout of Horizon Therapeutics became official earlier this month, one of the first orders of business for the California biotech giant was to get acquired blockbuster Tepezza back on track.

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Peggy Lillis Foundation Announces 14th Annual Gala To Mark the Beginning of C. diff Awareness Month and Launch of “See C. Diff” Campaign

Pharmacy Times

The annual gala returns to spread critical C. diff awareness and honor those who work tirelessly to combat this deadly infection.

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BJ’s Wholesale Club thanks members with free Thanksgiving turkeys

Drug Store News

From Nov. 1–9, members will be eligible to receive a digital coupon for a free fresh or frozen Butterball whole turkey when they spend $150 in the same transaction, in-club or online.

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Amid COVID slump, Pfizer turns attention to RSV launch and a potential future in obesity

Fierce Pharma

As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market.

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Dr.Jart+ announces K-pop band Enhypen as global brand ambassadors

Drug Store News

Enhypen will star in a new campaign titled “Supercharged repair, Cicapair,” which features each member of the band working to solve a unique challenge that is tied to a skin care benefit.

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Teamwork for Better Healthcare Solutions: Merging Clinical and Marketing Efforts

PharmExec

In the ever-evolving landscape of healthcare, it's vital for organizations to take steps toward bridging the gap between their clinical and marketing teams.

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Powered by $5M investment, startup Yuzu Health takes on insurers’ ‘brittle’ technology

Fierce Healthcare

Entrepreneur Max Kauderer thinks the company he has co-founded, a third-party administrator called Yuzu Health, can disrupt major insurance companies by helping offer small businesses more affordab | Third-party administrator Yuzu Health says it can help insurance companies and brokers provide small businesses up to 40% in savings.

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Sarepta’s disappointing data put the FDA in a difficult spot

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, all. Damian here with disappointing news on a closely watched gene therapy, an interesting deal in genome editing, and the long shadow of biotech’s slump.

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Addressing Challenges in Pediatric Tuberculosis Treatment

Drug Topics

Pediatric TB is an intricate challenge that demands continued attention and funding.

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Weekly injection shows promise for type 1 diabetes

European Pharmaceutical Review

Insulin icodec, a once-weekly basal injection to treat type 1 diabetes, has the potential to be as effective in managing the condition as daily basal insulin treatments, according to results of the year-long ONWARDS 6 Phase IIIa clinical trial, recently published in the Lancet. The study, conducted at 99 sites across 12 countries tested the efficacy and safety of a weekly basal injection of icodec (a long-lasting type of insulin) and compared it to a daily basal injection of insulin degludec in

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La Roche-Posay’s 'Healing Power of Touch' campaign supports cancer patients, caregivers

Drug Store News

In partnership with the Union for International Cancer Control, La Roche-Posay is launching a digital learning platform for cancer patients and caregivers.

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Open enrollment on the ACA exchanges is set to begin. Here are 5 trends to watch

Fierce Healthcare

Open enrollment on the Affordable Care Act's (ACA's) exchanges is set to begin, but signing up for coverage remains confusing for many, a

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Lay’s joins forces with ‘Vanderpump Rules’ stars on sandwich-inspired chip

Drug Store News

The limited-edition grilled cheese and tomato soup chips come in packaging inspired by Ariana Madix and Katie Maloney’s soon-to-be-opened sandwich shop, Something About Her.