Fri.Dec 02, 2022

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Early and Intense Flu Season Revs Up

Drug Topics

Flanked by RSV and COVID-19, flu season started early and rates of transmission are high throughout the country.

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Telehealth Availability Is Linked to Better Mental Health Engagement in Those With Medicaid

Pharmacy Times

Data show that despite declines in visit rates to federally qualified health centers, patients with psychological disorder diagnoses during COVID-19 did well when telemedicine was available.

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STAT+: Alzheimer’s researchers try out an unfamiliar sensation: optimism

STAT

SAN FRANCISCO — Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success. This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-lo

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Olutasidenib Gains FDA Approval for IDH1-Mutated Relapsed/Refractory Acute Myeloid Leukemia

Pharmacy Times

Olutasidenib (Rezlidhia) is indicated for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation detected by an FDA-approved test.

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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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Opinion: Congress: Close the gap between funding for nutrition research and the toll diet-related disease takes on Americans

STAT

You are what you eat. Every year, new scientific discoveries make clear that food is critical to health. In recent years, nutrition research trials have shown that a Mediterranean diet reduces cardiovascular disease; ultra-processed foods increase weight gain; omega-3 fatty acids improve IQ in preterm babies; cocoa prevents heart attacks; and vitamin D supplements do — well, almost nothing.

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Tune in for Coverage of the 2022 San Antonio Breast Cancer Symposium

Pharmacy Times

Pharmacy Times® will be onsite in Texas providing written and video content for the SABCS, which takes place December 6 to 10.

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More Trending

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Digital health VCs eye healthcare workforce, cancer care as ripe for startups in 2023

Fierce Healthcare

Digital health VCs eye healthcare workforce, cancer care as ripe for startups in 2023. hlandi. Fri, 12/02/2022 - 06:26.

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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT

The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment. The sources said its members were frustrated that it was late to engage when Congress was debating the Inflation Reduction Act, which gives Medicare the power to negotiate drug prices.

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Pharmacists Play Essential Role in Addressing Health Care Disparities

Pharmacy Times

Diversity, equity, and inclusion programs in pharmacy can lead to better health outcomes for patients.

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In Philadelphia, ‘tranq’ is leaving drug users with horrific wounds. Other communities are bracing for the same

STAT

PHILADELPHIA — The volunteers were handing out the staples of harm reduction: safe injection and smoking kits, condoms, and Narcan, the opioid overdose reversal medication. Down the line, they were distributing hats, socks, coats, and blankets to the people who use drugs who came to this outreach event on a recent Saturday, a bright, cold morning a few days before Thanksgiving.

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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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Telemedicine Can Help Facilitate Treatment for Opioid Use Disorder

Pharmacy Times

Program provides a virtual assessment and treatment with buprenorphine, a medication for opioid cravings and withdrawal symptoms.

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Image manipulation in science is suddenly in the news. But these cases are hardly rare

STAT

In 2004, Mike Rossner and Kenneth Yamada, two top editors at the Journal of Cell Biology, wrote an editorial alerting readers to what they saw as an emerging problem in science: Thanks to Photoshop, researchers could prettify the images in their manuscripts in ways that might cross the line into deception in an effort to clear the bar of peer review.

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FDA to Revise Labeling for Prescription Cough Medicine Following Overdose Concerns in Young Children

Pharmacy Times

Benzonatate overdoses were reported in children under 2 years of age after accidentally ingesting as few as 1-2 capsules.

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STAT+: An Anavex study spin job sullies an otherwise spectacular Alzheimer’s conference

STAT

Anavex Life Sciences said Thursday that its experimental treatment for Alzheimer’s disease slowed the rate of cognitive decline in a clinical trial — but only by changing the study’s primary efficacy goals, omitting patients from the analysis, randomly altering data, making basic math errors, whistling past safety concerns, and using nonsensical statistical tests.

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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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Do amoxicillin and alcohol mix?

The Checkup by Singlecare

If you come down with a bacterial infection, you may be prescribed an antibiotic like amoxicillin. Treatment with amoxicillin typically lasts for several days, so you might be wondering whether combining amoxicillin and alcohol is safe, especially if the treatment course falls on a weekend or special occasion when you might be offered a cocktail or a glass of wine.

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STAT+: Inside one startup’s quest to build proteins from scratch using artificial intelligence

STAT

A Somerville startup and an academic lab in Seattle say they have developed a way to use artificial intelligence to design proteins that don’t exist in nature. Proteins help people move, digest food, and fight infections — to name a few of their numerous functions. They’re also the basis of a nearly  $300 billion  drug industry for treating cancer, immune diseases, and other conditions.

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Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

pharmaphorum

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability. The challenge the industry faces, however, is that operational certainty is exacerbated by the impact of global disruptions, such as the effect of COVID-19, natural disasters, and regional conflicts.

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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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Industry Voices—The changing digital health landscape

Fierce Healthcare

Industry Voices—The changing digital health landscape. hlandi. Fri, 12/02/2022 - 11:20.

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Vaccines Europe launches first pipeline review

European Pharmaceutical Review

Vaccines Europe has unveiled its first pipeline review of its 15 members companies, with 100 vaccine candidates as of July 2022. . The review revealed a pipeline aimed at tackling current and future challenges, such as antimicrobial resistance (AMR) and respiratory tract infections, through leveraging a wide range of new technology platforms. The data indicated 46 percent of the vaccine candidates target infections that do not have an available vaccine.

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Advocate Aurora Health, Atrium Health close megamerger, forming the nation's 5th largest nonprofit system

Fierce Healthcare

Advocate Aurora Health, Atrium Health close megamerger, forming the nation's 5th largest nonprofit system. pminemyer. Fri, 12/02/2022 - 16:26.

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Pfizer’s €1.2 billion manufacturing site expansion

European Pharmaceutical Review

Pfizer Inc. has announced it will invest over €1.2 billion in its manufacturing site in Grange Castle , Dublin, the company’s biggest expansion investment to date in Ireland. A new facility will be built on the site premises, doubling the capacity for biologics manufacturing at the facility. It is anticipated a further 400-500 roles will be created, bringing the total Pfizer employees in Ireland to around 5,500.

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HHS bulletin clarifies when pixel tracker use may violate HIPAA

Fierce Healthcare

HHS bulletin clarifies when pixel tracker use may violate HIPAA. pminemyer. Fri, 12/02/2022 - 15:21.

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With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker

Fierce Pharma

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker. fkansteiner. Fri, 12/02/2022 - 09:51.

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STAT+: Pharmalittle: Private equity moving to buy clinical trials firms; data provider limits media access to drug prices

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, for now, appears rather modest. We plan to promenade extensively with the official mascot, catch up on our reading, and have a listening party with Mrs. Pharmalot. And what about you?

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KFF: More large employers and unions turn to Medicare Advantage to offer retiree health benefits

Fierce Healthcare

KFF: More large employers and unions turn to Medicare Advantage to offer retiree health benefits. rking. Fri, 12/02/2022 - 16:04.

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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Pharmaceutical Technology

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world. It has been approved for restricted use in emergencies for people aged 18 and above in India for the first two-dose schedule and homologous booster doses.

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Oura launches employer-focused wellness arm

Fierce Healthcare

Oura launches employer-focused wellness arm. aburky. Fri, 12/02/2022 - 11:49.

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UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer

Fierce Pharma

UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer. zbecker. Fri, 12/02/2022 - 11:22.

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CMS gives providers breathing room on looming advanced good faith cost estimates

Fierce Healthcare

CMS gives providers breathing room on looming advanced good faith cost estimates. rking. Fri, 12/02/2022 - 14:29.

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FDA approves Rezlidhia™ for leukaemia

European Pharmaceutical Review

Rigel Pharmaceuticals, Inc. has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The FDA approval was supported by open-label Phase II registrational study data, which showed a twice per day 150mg dose of Rezlidhia facilitated a complete remission (CR) + CRh rate of 35 percent of the 153 patients observed.

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Becerra decides to not extend mpox public health emergency set to expire next month

Fierce Healthcare

Becerra decides to not extend mpox public health emergency set to expire next month. rking. Fri, 12/02/2022 - 16:39.

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FDA Grants Fast Track Designation to CAR T-Cell Therapy That Achieved 100% Complete Response in Lymphoma Patients

Pharmacy Times

The allogeneic CAR-T cell therapy is in development for relapsed or refractory large B cell lymphoma and relapsed or refractory B cell non-Hodgkin lymphoma.

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CDC awards $3.2B to public health departments

Fierce Healthcare

CDC awards $3.2B to public health departments. fdiamond. Fri, 12/02/2022 - 08:25.

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