Thu.Oct 31, 2024

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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?

Drug Topics

Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.

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STAT+: These 10 scientists are leading a new generation of gene editors developing CRISPR medicines

STAT

Barely 12 years after the publication of the first papers unveiling CRISPR-Cas9, a powerful enzyme for editing DNA, sickle cell patients are now receiving the first approved CRISPR-based medicine, Casgevy. Hundreds of patients with other inherited diseases, cancers, and chronic bacterial and viral infections are enrolled in clinical trials testing other CRISPR treatments.

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How to Turn Patient Visits into Clinical Encounters in the Pharmacy | NCPA 2024

Drug Topics

Presenters at the National Community Pharmacists Association 2024 Annual Convention and Expo discussed workflow and the future of pharmacy as a patient destination.

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Limiting sugar in infancy is tied to less diabetes and hypertension in adulthood

STAT

Britain’s hardships during World War II famously included weeks of bombing during the Blitz, the mass evacuation of children, and food rationing. That rationing, researchers report, holds cautionary lessons for today on the health impact of consuming sugar early in life.  Black-and-white wartime photos capture long queues in the shops when supplies of meat, dairy, sugar, and other food were limited.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Community Pharmacies in Crisis: Navigating the Challenges and Closures

Pharmaceutical Commerce

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

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STAT+: To mitigate drug shortages, a new study suggests looking at Canada

STAT

Of 104 reports of supply chain issues with dozens of drugs, meaningful shortages were 40% less likely to occur in Canada than in the U.S., a new study found, and the difference was largely attributed to the approach taken by the Canadian government to the problem. Between 2017 and 2021, regulators in the U.S. and Canada received the same number of reports about actual or potential shortages for the same 96 medicines.

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STAT+: Two generic drugmakers pay $49 million to settle price-fixing charges

STAT

Two generic drugmakers, Apotex and Heritage Pharmaceuticals, have agreed to pay a combined $49 million to settle allegations they fixed prices on numerous medicines, the first such agreements since state attorneys general began probing price-fixing in the generics industry a decade ago. In 2016, a number of states filed what eventually became the first in a trio of lawsuits against many of the largest generic companies for allegedly coordinating efforts to fix and maintain prices for dozens of m

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Patient Engagement and the Future of Community Pharmacy as a Health Care Destination

Drug Topics

Ian Stone, Senior Vice President at Mesmerize, discussed the essential aspects of a community pharmacy and how his company can help independent owners excel in the future.

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STAT+: Teva fined $503 million for disparaging a rival and using patents to thwart competition

STAT

Teva Pharmaceutical, the world’s largest generic drugmaker, was fined $503 million by European antitrust regulators for delaying competition to a blockbuster multiple sclerosis medicine. The European Commission found the company had artificially extended the patent protection of Copaxone and systematically spread misleading information about a rival product.

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Optum Rx rolling out new initiatives aimed at supporting independent pharmacists

Fierce Healthcare

Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs. | Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.

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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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Should race be used in clinical algorithms? How one doctor’s research is helping shape policy

STAT

When the murder of George Floyd in 2020 ignited calls for racial equity across the U.S., the field of medicine confronted its own thorny questions about race. James Diao, then a medical student at Harvard Medical School, was among the many people who zeroed in on one particular issue: If race is a social construct, why was it a factor in clinical tools used to determine a patient’s risk of disease?

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As new drugs deliver, Bristol Myers CEO looks to 'further improve productivity and efficiency'

Fierce Pharma

Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push. | Bristol Myers' $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company's ongoing efficiency push. The drugmaker is "exploring opportunities to further improve productivity and efficiency," CEO Chris Boerner said Thursday.

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STAT+: Small mid-stage trial suggests targeted magnetic pulses to brain could slow Alzheimer’s

STAT

After spending decades fixated on a single hypothesis, Alzheimer’s researchers are increasingly searching for new ways to combat the devastating neurologic disease. One such approach — precisely targeting the brain with magnetic pulses — got a boost when mid-stage trial data was presented Thursday. Scientists reported that patients with mild or moderate Alzheimer’s who received the therapy, known as transcranial magnetic stimulation (TMS), experienced a 44% slowing in

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Cigna posts $739M in Q3 profit despite taking a $1B hit from VillageMD investment

Fierce Healthcare

The Cigna Group reported $739 million in profit for the third quarter, a figure that accounts for a $1 billion after-tax investment loss tied to VillageMD. | The Cigna Group reported $739 million in profit for the third quarter, a figure that accounts for a $1 billion after-tax investment loss tied to VillageMD.

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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+: Apple claims new AirPod hearing aid feature is ‘clinical grade.’ Is it?

STAT

Apple this week officially released a batch of new health features for AirPods Pro that allow users to test their hearing and use the popular wireless headphones as hearing aids for milder forms of hearing loss.  After they were announced in September, audiologists and other experts immediately praised Apple’s efforts. Many people with hearing impairment  never get tested or seek treatment, so the new tools from one of the world’s largest tech companies could help boost a

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FDA removes Novo's Wegovy from shortage list, marking end of semaglutide supply rout in US

Fierce Pharma

Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S.

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UnitedHealth Group, University of Minnesota partner to launch course on value-based care

Fierce Healthcare

Making true progress toward value-based care requires buy-in and understanding from physicians — and for them to be willing to find common ground with insurers for collaborating. | UnitedHealth Group partnered with the University of Minnesota's medical school to launch a four-week elective course that exposes fourth-year medical students to value-based care and has them working in person with Optum clinicians.

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Gardasil's China troubles haunt Merck in Q3, with execs warning of more obstacles ahead

Fierce Pharma

While Merck's oncology powerhouse Keytruda delivered another multibillion-dollar sales haul in the third quarter, regional fright surrounding another staple product took the spotlight during the co | Despite the China growth woes, Merck is still confident it can achieve its $11 billion sales goal for the HPV vaccine by 2030.

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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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Simultaneous Zoster, Inactive Quadrivalent Influenza Vaccination Shows Acceptable Safety for Older Adults

Pharmacy Times

The simultaneous doses of both vaccines compared with individual RZV and quadrivalent high-dose inactivated influenza vaccine (HD-IIV4, Fluzone; Sanofi) had similar overall safety findings.

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It's a monster MASH for Madrigal as Rezdiffra has caught on in a flash

Fierce Pharma

Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potentia | Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potential blockbuster Rezdiffra. In its second full quarter on the market, the fatty liver disease drug racked up sales of $62 million, which routed Wall Street's expectations and triggered a 16% surge in Madrigal's share price.

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Novo Nordisk Foundation Announces Start Up of Denmark’s First AI Supercomputer Geared to Accelerate Drug Discovery Innovation

BioPharm

The Novo Nordisk Foundation has committed DKK 600 million (US$87.4 million) towards the initial costs of the center housing the new supercomputer, which has the potential to accelerate drug discovery innovation.

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Bird flu is now in a pig (not good)

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Happy Halloween! Tonight I am going to a wedding rehearsal dressed as Jo March from “Little Women.” The bride and groom are dressing up as Buttercup and Westley from “The Princess Bride,” which is maybe the most precious thing I have ever heard.

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Why language training is crucial for healthcare teams

pharmaphorum

Effective language training for healthcare teams within the NHS is crucial for providing quality care and communication with diverse patient populations. Learn why it is essential for healthcare professionals.

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STAT+: Pharmalittle: We’re reading about the FDA listing Novo drugs as ‘available,’ pharma layoffs, and more

STAT

Rise and shine, everyone, another busy day is on the way. We can tell by the sudden presence of little ghouls and goblins walking past. No doubt, they are in search of the great pumpkin. We wish them luck, because you never know what you may find on that elusive quest. Of course, this calls for a cup of stimulation, and we are opening a new package of pecan pie for the occasion.

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Teva fined €462.6m for antitrust delay to MS drug rivals

pharmaphorum

The European Commission has delivered a hefty fine to Teva for abusing a dominant position in multiple sclerosis by artificially extending the patent protection for former blockbuster Copaxone.

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Independent Pharmacies Should Expand Their Vaccination Programs | NCPA 2024

Drug Topics

A conversation with David Ha, PharmD, BCIDP, at the National Community Pharmacists Association 2024 Annual Convention and Expo.

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NCODA Fall Summit Recap: Key Sessions and Expert Interviews From the 2024 Meeting

Pharmacy Times

The 2024 NCODA International Fall Summit took place in Orlando, Florida, from October 23 to October 25.

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Opinion: Medicare’s hidden information hurts people, policy

STAT

Open enrollment season for Medicare, which began Oct. 15 and ends Dec. 7, triggers a deluge of information about various options. Since I’m a health care consultant and researcher as well as a Medicare beneficiary, I’ve looked critically at what we’re told and what we’re not. Unfortunately, information crucial both for the individual and for the broader policy goal of moving toward a “value-based” care system is often difficult to find or not available a

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Regeneron's Eylea HD makes progress but doesn't dent the momentum of Roche's Vabysmo

Fierce Pharma

With U.S. | With U.S. sales of $392 million in the third quarter, Regeneron’s high-dose version of Eylea is closing in on blockbuster sales in its first full year on the market. The bad news for the company, however, is that while sales from Eylea HD increased by 29% sequentially, this didn't translate to a similar bump in overall U.S. revenue for the Eylea family of eye medications.

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The Essential Tech Stack for Pharmacy Owners

Drug Topics

Lisa Faast, PharmD, Founder and CEO of Diversify Rx, discussed how technology is used to innovate within the pharmacy.

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Alpha-9's $175m third-round heads latest biotech financings

pharmaphorum

Our latest round-up of financings in the biotech sector features Alpha-9 Oncology, Axonis, Kivu Bio, SynOx, Agomab, and Blue Earth Therapeutics.

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Higher MA enrollment linked to lower Medicare spending: report

Fierce Healthcare

Medicare Advantage’s popularity is associated with lower total Medicare spending, a new report from Elevance Health finds. | Elevance Health researchers might have an explanation for lower-than-expected Medicare spending: the proliferation of Medicare Advantage plans.

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Smoking Cessation Within 6 Months of Cancer Diagnosis Boosts Survival Rates for Patients With Lung Cancer

Pharmacy Times

Following lung cancer diagnosis, adjusting lifestyle habits can improve treatment responses.

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