Thu.Sep 26, 2024

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Chronic Pain Linked to Higher Anxiety, Depression in Youth

Drug Topics

Study findings raise concern about increased pain and disability, poorer pain self-management, and impaired quality of life during adolescence that can continue into young adulthood.

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Behind the rise BMS’ KarXT, the first new schizophrenia drug in decades

PharmaVoice

KarXT’s approval demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.

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Lupus Nephritis Treatment Shows Positive Results in Phase 3 Trial

Drug Topics

Genentech said it’s sharing the data with global health authorities to make the therapy available to patients as soon as possible.

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Roivant’s magic trick: Finding the ‘weird-shaped’ pieces around Big Pharma’s cookie cutters

PharmaVoice

Roivant CEO Matt Gline leads the company on a unique path by placing bets on misfit drugs and technologies — and it’s working.

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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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Drug Topics Top 10: Most Read Stories From September 2024

Drug Topics

Check out this list of our top 10 stories from September 2024.

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STAT+: FDA approves schizophrenia drug that could alter how disorder is treated

STAT

For decades, doctors caring for people with schizophrenia have relied on mood-regulating drugs that target the brain chemical dopamine. On Thursday, the Food and Drug Administration approved for the first time a new type of medicine that may change the way the psychiatric disorder is treated.  The drug, called Cobenfy, will be sold by Bristol Myers Squibb.

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STAT+: What Pfizer’s decision to pull its sickle cell drug means for patients, the company, and the FDA

STAT

Pfizer’s decision Wednesday to pull its sickle cell pill off the market because of safety concerns shocked advocates and doctors, leaving many searching for answers and scrambling for ways to notify their patients about a drug that has long divided the community.  The move underscored the severity of the risks recently seen in studies of the drug, Oxbryta , in which researchers have reported a number of deaths among patients who were receiving it.

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Community Pharmacy Vaccine Promotions Often Neglect Vulnerable Populations

Drug Topics

Researchers aimed to address how community pharmacies target vulnerable groups regarding the promotion of vaccinations.

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Morehouse School of Medicine launches pain equity course focused on racial healthcare disparities

Fierce Healthcare

One of the first pain equity courses for medical students is launching at the Morehouse School of Medicine this fall. | The course offers insights into fostering safe, trustworthy, transparent and empathetic patient-provider interactions. It also emphasizes how to address the unique preferences and needs of Black patients in pain.

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Discussing Resources for Pharmacists with Substance Use Disorder

Drug Topics

For National Recovery Month, Drug Topics sat down with Jake Nichols, PharmD, MBA, to discuss what kinds of resources there are for pharmacists dealing with a substance use disorder.

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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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STAT+: Sleep apnea alert on Apple Watch: What does it mean, and how does it work?

STAT

This month, Apple launched a feature for the Apple Watch that alerts users if it determines they may have sleep apnea, potentially leading to treatment for a dangerous health condition that often goes undiagnosed.  Some see this as a good thing: Untreated sleep apnea, a condition where breathing is repeatedly disrupted during sleep, can result in persistent daytime tiredness and in the worst cases, cardiovascular diseases that hasten death.

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AbbVie Announces Positive Topline Results From Phase 3 Parkinson’s Disease Monotherapy Trial

Drug Topics

In the TEMPO-1 trial, both tavapadon doses effectively reduced motor symptoms in patients with early-stage Parkinson's disease.

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STAT+: Biden administration axes proposal to mandate more drug price transparency in Medicaid

STAT

Biden administration officials have abandoned their own proposal to require drug companies to disclose the prices and research costs of drugs that are driving up spending in state Medicaid programs. Pharmaceutical companies and lobbying groups heavily pressured the Centers for Medicare and Medicaid Services to abandon the little-noticed idea to create “drug price verification surveys” — they indirectly threatened to sue if the government moved forward with it.

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Semaglutide May Protect Against Opioid Overdose in OUD

Drug Topics

Investigators used electronic health record data to compare outcomes of semaglutide vs other antidiabetic medications.

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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+: Epic Systems has been challenged in court before, but its different this time

STAT

Epic Systems is no stranger to the courtroom. The nation’s largest vendor of electronic health records has fought, and won, legal fights with rivals large and small for many decades. But a new antitrust lawsuit filed this week by Particle Health , an upstart health data company, presents an especially direct threat to Epic’s dominance in the multi-billion dollar market surrounding patient data, legal and health policy experts told STAT.

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FDA Approves Osimertinib for Unresectable EGFR-Mutated Lung Cancer

Pharmacy Times

The decision is based on positive results from the phase 3 LAURA trial.

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STAT+: ARCH Venture Partners raises $3 billion for a new biotech fund

STAT

ARCH Venture Partners has raised $3 billion for a new fund — one of the largest in the biotech industry, and one the VC firm will use to continue its contrarian investment strategy.  The last few years have tested many venture firms: biotech stocks dropped, valuations shifted, and the flow of fresh capital forced many startups out of business before signs of a recovery emerged.

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Komodo Health rolls out new gen AI tools to sift through healthcare data, speed up analysis

Fierce Healthcare

Komodo Health continues to invest in generative AI capabilities, seeing the potential to use AI-powered conversational language to make it easier for health research teams to parse through troves o | Komodo Health continues to invest in generative AI capabilities, seeing the potential to use AI-powered conversational language to make it easier for health research teams to parse through troves of data.

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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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STAT+: Cassava Sciences and former execs, facing SEC charges for misleading claims, agree to fines

STAT

Facing charges from the Securities and Exchange Commission for misleading claims related to a controversial Alzheimer’s drug candidate, Cassava Sciences and two of the company’s former executives have agreed to pay fines, the company announced Thursday. The news comes on the same day that the SEC filed charges against Cassava, former CEO Remi Barbier, and former senior vice president of neuroscience Lindsay Burns.

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Advocates urge FTC to block McKesson, Cardinal Health's big-ticket oncology acquisitions

Fierce Healthcare

Citing fears of vertical integration and reduced competition, anti-monopoly advocacy group American Economic Liberties Project and a small cadre of other advocacy organizations are urging federal r | Anti-monopoly group American Economic Liberties Project and others say the vertical integration deals will stamp out competition in already concentrated markets, ultimately harming patients.

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STAT+: FDA introduces plan to assess safety of common chemicals added to food

STAT

SILVER SPRING, Md. — Food additives rarely face FDA scrutiny once they’re on the market, even those with mounting evidence of safety concerns. At a meeting held by the Food and Drug Administration on Wednesday, regulators said they plan to change that.  The public meeting on the FDA’s campus drew dozens of food safety advocates, industry representatives, concerned citizens, and state and federal lawmakers.

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Insurers not covering 12-month contraception supply as required: study

Fierce Healthcare

State laws mandate insurers cover a 12-month supply of contraception but this requirement is rarely followed by insurers, a JAMA Health Forum study reviewing Medicaid plans in nearly a dozen states | Insurance plans are supposed to cover a 12-month supply of birth control pills, but a recent study found that requirement is rarely followed.

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Opinion: Congress must reauthorize the Older Americans Act to keep seniors safe from heat

STAT

On Wednesday, Congress passed a temporary spending bill that keeps the government funded beyond Sept. 30. Yet, even in light of lawmakers averting a shutdown, there is another end-of-moth deadline looming they’ve largely ignored: expiration of foundational aging and disability legislation called the Older Americans Act (OAA). The OAA supports the delivery of home and community-based social and services that improve the lives, dignity, safety and wellbeing of older adults.

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Concerns of the At-Home FluMist Emphasize Need for Patient Safety, Proper Administration

Pharmacy Times

Issues around patient safety, proper administration, and monitoring need careful consideration from pharmacists and other health care providers for vaccination efforts.

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STAT+: Two reports, two dramatically different views of nonprofit hospitals’ tax breaks

STAT

Within a few days of one another, two teams of accountants released separate estimates on the value of nonprofit hospitals’ tax exemptions. Their wildly different findings underscore the degree to which who’s counting and what they count matters.  The first, a JAMA study published today , pegged that number at $37.4 billion. It factored in the value of forgone federal and state income taxes, sales tax, property tax, federal unemployment tax, charitable contributions from donor

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Providers and payers ramp up investments in cybersecurity, AI in 2024

Fierce Healthcare

Providers and payers are investing more in IT infrastructure in response to the Change Healthcare cyberattack earlier this year, and organizations seem willing to experiment with AI and n | A new report by KLAS Research and Bain & Company found that the majority of providers and payers are investing more money than ever into healthcare technology to improve cybersecurity, operations and customer engagement.

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STAT+: Gene therapy for sickle cell disease remains a tough business model — and may never work

STAT

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. The  deep financial restructuring  announced by Bluebird Bio this week offered another reminder that groundbreaking genetic medicines capable of transforming the lives of people with inherited disease are not now — and may never become — a sustainable business.

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Vicebio raises $100m for vaccines and other bio financings

pharmaphorum

Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.

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Higher buprenorphine doses prevent hospitalization of people with fentanyl addiction, study finds

STAT

Patients who received higher doses of buprenorphine, a common medication used to alleviate opioid withdrawal and cravings, were less likely to be hospitalized and less likely to discontinue treatment, according to a new study.  The findings run counter to federal guidelines about buprenorphine dosing. Currently, the Food and Drug Administration recommends a target dose of 16 mg.

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MSD hits a hurdle with its LAG-3 programme

pharmaphorum

MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac

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Biotech’s real estate market is still upside down

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. It’s another busy news day, and I’m layering up at home to avoid turning the heater on. Fall is officially here.

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Experts support FDA's plan for biomarker-based restriction on PD-1 drugs in stomach cancer

Fierce Pharma

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

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STAT+: Medicare will continue its cautious approach to paying for Alzheimer’s drugs

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. AAM picks up laid-off BIO exec Redox reactions – when an atom loses an electron that is picked up by another atom– are common to some basic functions of life, including photosynthesis, respiration, combustion.

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