Fri.Mar 08, 2024

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FDA Approves Semaglutide for New Indication Involving Cardiovascular Disease

Pharmacy Times

Semaglutide (Wegovy; Novo Nordisk) reduces the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight when combined with the standard-of-care.

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STAT+: In stunning outcome, Amylyx’s ALS drug fails large clinical trial

STAT

Amylyx Pharmaceuticals said Friday that its treatment for ALS, called Relyvrio, failed to provide any benefit for patients in a large clinical trial — a stunning outcome that now has the company considering a voluntary withdrawal of the approved medicine from the market. “This is really hard for us, and it’s really hard for our team who care so much, but it’s so much harder for people with ALS and their families, and we have to keep that perspective,” said a so

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FDA Questions Donanemab Efficacy for the Treatment of Alzheimer Disease

Pharmacy Times

The FDA is convening a committee to discuss phase 3 data after the planned action date, which delays drug availability to patients.

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STAT+: Amylyx ALS drug failure leaves patients, advocates, and researchers reeling — and wondering what’s next

STAT

The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians, forcing the community to consider just what to do with an approved medicine that doesn’t appear to work. Amylyx Pharmaceuticals’ announcement Friday that its drug, marketed as Relyvrio, failed to beat placebo in a pivotal study marks “a sad day for us, but we have to believe the data,” said Mary Catherine Collet, an ALS advocate.

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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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President Biden Announces Desire to Cap Drug Prices for All Americans

Pharmacy Times

In the State of the Union Address, President Biden said he wants to expand the $2,000 out-of-pocket cap beyond seniors and allow Medicare to negotiate more costly drugs.

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STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

U.S. regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. The new label indicates that Wegovy can reduce the risk of major heart complications — including heart attack, stroke or cardiovascular-related deaths — for people with overweight or obesity and existing heart disease, Novo said in a statement Friday.

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STAT+: IVF doctors demand full details on fluid that grows embryos amid CooperSurgical lawsuits

STAT

Patients from all over the country are filing lawsuits against medical supply giant CooperSurgical, alleging that fluid the company sent to in vitro fertilization clinics destroyed their embryos. The fluid, called culture media, is filled with nutrients that allow embryos to develop enough to ultimately be implanted into a uterus. CooperSurgical acknowledged that the batch of fluid may have stunted embryo growth in a product recall notice , but it hasn’t disclosed exactly what went wrong.

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Guiding Women Within Health Care and the Significance of Self-Development, Improvement

Pharmacy Times

The vice president and chief pharmacy officer at City of Hope explains how she serves as a mentor for women within health care, the importance of networking, and staying educated.

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STAT+: In surprise move, FDA calls for advisory committee on Lilly’s Alzheimer’s drug

STAT

In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month. The drug, donanemab, succeeded in its Phase 3 trial , resulting in a 35% slowing of Alzheimer’s disease progression versus placebo.

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Industry Voices—A new reimbursement model is needed to ensure the future of community pharmacy

Fierce Healthcare

Community pharmacies are well positioned to make a difference in the lives of their patients by providing convenient access to quality, affordable clinical pharmacy services while closing gaps in c | The current environment of decreasing reimbursement and increasing drug costs is not sustainable for either chain or independent pharmacies.

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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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Report: 2024 Projected to Be A Big Year for Biosimilars in the Retina Space

Pharmacy Times

Cardinal Health released its 2024 biosimilars report, including research and in-depth analyses on legislative development, payer landscapes, and new treatments in the pipeline.

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A disabled artist’s journey from ‘Oh, sorry’ to social justice activism

STAT

Sonya Rio-Glick was born three months and six days premature, alongside her twin, in the summer of 1997. Both had health complications. Sonya had cerebral palsy but wasn’t formally diagnosed until she was 2, after a physical therapist approached her parents at a party. That’s when her family learned what had made Rio-Glick move differently since infancy.

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ViVE 2024: How Elevance Health is aiming to make its data insights actionable for providers

Fierce Healthcare

LOS ANGELES—Health insurers have access to a bevy of valuable data, and the push toward interoperability made it easier for those data to be shared with providers. | LOS ANGELES—Payers have access to a wealth of data, but the challenge now becomes making those data usable and useful for providers in a way that does not disrupt their workflows and interactions with patients.

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STAT+: UnitedHealth gives timeline for Change restoration: payments up by late next week

STAT

Change Healthcare’s parent company said it’ll have its electronic payment function up and running by late next week after a February cyberattack took many of its systems offline. Its claims network and software will take longer. UnitedHealth Group said clients will be able to reconnect to Change’s electronic payment system on March 15.

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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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With 2 acquisitions under its belt and $80M from investors, Fabric is building tech to fix healthcare's capacity problem

Fierce Healthcare

With 2 acquisitions under its belt and $80M from investors, Fabric is building tech to fix healthcare's capacity problem hlandi Fri, 03/08/2024 - 12:51

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Breaking: FDA Approves Wegovy to Reduce Cardiovascular Risks in Overweight, Obesity

Drug Topics

Study results demonstrated the efficacy of semaglutide (Wegovy) in reducing cardiovascular risks in adults with overweight or obesity without diabetes.

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Accelerating inclusion in innovation: Gender diversity in clinical research

pharmaphorum

Clinical research continues to struggle with a lack of representation within trial populations, and gender diversity in clinical trials remains a critical issue. Learn about the importance of gender diversity in clinical research trials and how it can accelerate inclusion in innovation.

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Belantamab Mafodotin Regimen Indicates Safety, Improved OS in Patients Treated With Multiple Myeloma

Pharmacy Times

Despite the belantamab mafodotin regimen improving overall survival in patients with relapsed or refractory multiple myeloma, the trial is ongoing to confirm the presented results.

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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: STAT+: It’s time to rethink everything about our approach to psychiatric drug development

STAT

In many ways, psychiatry is still flying blind. People experiencing mental health conditions are prescribed various drugs until one (or a combination) finally works — a painful process that can take years. As a psychiatrist and neuroscientist, I became increasingly impatient and frustrated with this ineffective way of treating patients. This guided the core question behind my research: Can biology explain how people with the same psychiatric disorder respond differently to the same treatm

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Women in life sciences: Miruna Sasu

pharmaphorum

Celebrate International Women’s Day by learning about Miruna Sasu, a prominent female figure in the life sciences field and CEO of COTA. Explore how the company uses AI in the oncology space.

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AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

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Diabetes care is too fragmented and education gaps are rife, new report shows

Fierce Healthcare

More than half of diabetes patients believe that popular weight loss drugs alone may improve their health, according to a new report. | More than half of diabetes patients believe that popular weight loss drugs alone may improve their health, indicating that the hype around buzzy new medications may be creating some false hope.

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Bridging the gap: Uniting stakeholders through a digital ecosystem for holistic maternity care

pharmaphorum

Discover how a digital ecosystem can unite stakeholders in providing holistic maternity care, enhance maternal and postpartum care outcomes, and bridge the gap in healthcare services.

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PhRMA seeks to revive Medicare price negotiations lawsuit, blasts Biden's request for IRA expansion

Fierce Pharma

As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.

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Women in life sciences: Angie Franks

pharmaphorum

Angie Franks is a prominent female figure in the life sciences industry and perfect to highlight on International Women's Day. Learn more about her contributions and achievements in healthcare and technology.

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Exploring Electronic Cigarettes’ Success Among Other Tobacco Cessation Methods

Drug Topics

Researchers assessed the benefits of electronic cigarettes for tobacco cessation compared with varenicline and nicotine chewing gum.

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Johnson & Johnson acquires Ambrx Biopharma for $2bn

Pharmaceutical Technology

Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.

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WellSpan rolls out AI-driven clinical documentation tool from Nuance to free up providers' time

Fierce Healthcare

WellSpan Health is taking the burden off its providers by deploying an AI-driven clinical documentation tool from Nuance. | DAX Copilot, from Microsoft’s speech recognition subsidiary Nuance Communications, integrates with Epic to draft clinical notes during visits. This process happens within seconds, the company claims, and makes the note available for review and entry into the EHR by clinicians.

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Female Leadership, Empowerment, and Self-Advocating Key to Overcoming Gender Inequities in Health Care

Pharmacy Times

The vice president and chief pharmacy officer of City of Hope discusses obstacles women face in health care and how diversity, equity, and inclusion can be promoted within the space.

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Bristol Myers, overshadowed by ADC rival, wins FDA nod for Opdivo combo in bladder cancer

Fierce Pharma

Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck &amp | Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck & Co.’s Keytruda, has impressed in a high-profile treatment combo.

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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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9 health benefits of sardines

The Checkup by Singlecare

Sardines have long been a canned seafood mainstay. But affordability and convenience aside, are sardines good for you? Experts say yes. These small fish are an excellent source of protein and omega-3s, a type of polyunsaturated fatty acid (PUFA). They’re also rich in vitamin D and minerals like iron and calcium. 9 health benefits of sardines Sardines are an animal protein complete with all the amino acids your body needs.

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BeiGene secures accelerated FDA approval for follicular lymphoma treatment

Pharmaceutical Technology

The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.

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