Sat.Sep 21, 2024 - Fri.Sep 27, 2024

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For Pharmacists With Substance Use Disorders, Recovery Is Possible

Drug Topics

Pharmacy professionals are at an increased risk of substance abuse due to many factors, but long-term recovery can be achieved with the help of specialized recovery networks.

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STAT+: Pfizer pulls sickle cell treatment Oxbryta off global markets

STAT

Pfizer said Wednesday that it was removing Oxbryta, a pill for the treatment of sickle cell disease, from all markets globally due to high risks of severe safety events, including deaths.  The decision is a stunning blow for a drug that was approved in 2019 , heralded as a new way to treat the inherited blood disorder. Pfizer acquired the maker of Oxbryta, a biotech company called Global Blood Therapeutics, in 2022 for $5.4 billion.

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Startup Particle Health files antitrust lawsuit against Epic alleging it uses monopoly power to block competition

Fierce Healthcare

What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations. | Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records giant is trying to muscle out competition in the payer platform market.

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Black Women With Breast Cancer Have Higher Risk of Death Compared With White Women

Pharmacy Times

Study results showed that Black women with breast cancer were more likely to die across all subtypes, with the disparity varying from 17% to 50% depending on subtype.

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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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Weekend ICYMI: September 16 to September 20

Drug Topics

In case you missed it, this week we had news about end-of-year PBM reform on the horizons, cebranopadol as a transformational new pain therapy, success in co-administration of RSV and shingles vaccines, and more.

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Four more health care workers reported illnesses after caring for bird flu case in Missouri

STAT

An investigation into the still unexplained human H5N1 bird flu infection in Missouri has turned up four additional health care workers who developed mild respiratory illness symptoms after caring for the patient in hospital in August, the Centers for Disease Control and Prevention reported on Friday. It is not clear if any of these people were actually infected with H5N1; they were not tested at the time when they were ill.

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Don’t Miss These Key Interviews, Data At the International Myeloma Society 2024 Congress

Pharmacy Times

The meeting will focus on the basic, preclinical, and clinical aspects of myeloma, including precursor disease, high-risk disease, immunotherapies, novel biomarkers, and more.

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Schizophrenia Drug Approved by FDA Represents First New Treatment Option in Decades

Drug Topics

The approval of xanomeline and trospium chloride (Cobenfy) from Bristol Myers Squibb represents a “transformative moment in the treatment of schizophrenia.

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Opinion: Sequencing wastewater material may be the key to getting a grip on the H5N1 bird flu outbreak

STAT

Despite no known infections of H5N1 bird flu among its dairy cows, Missouri recently detected a case in a person with no apparent exposure to possibly infected animals or related products (i.e., raw milk). A close contact and two health workers who cared for the person all developed respiratory symptoms , but were never tested. There has not yet been a wider uptick of other potential cases in the same community to indicate efficient human-to-human transmission — the evolution of which is

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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

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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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FDA Approves Cobenfy, Previously KarXT, for Treatment of Schizophrenia

Pharmacy Times

Xanomeline and trospium chloride is the first in a new class, offering a new approach with selectively targeting M 1 and M 2 receptors.

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Novo Nordisk CEO Agrees to Work With PBMs to Negotiate Lower Semaglutide List Prices

Drug Topics

Senators sought to uncover why prices of Novo Nordisk’sGLP-1 receptor agonist semaglutide are significantly higher in the US compared with countries in Europe.

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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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HHS OIG finds gaps in opioid treatment for Medicare, Medicaid enrollees

Fierce Healthcare

Many counties do not have medication for opioid use disorder (MOUD) services available through providers and treatment programs, and even in counties that do, Medicare and Medicaid beneficiaries of | A new report from HHS OIG looked at access to medication for opioid use disorder services and found many high need counties do not have specialized providers.

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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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Biosimilars Provide VA With Cost Savings for Treatment of Psoriasis

Pharmacy Times

Additional education can address ambivalence for patients and providers, which can start at the pharmacist level, as they are essential sources of information for patients.

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Now Trending: Fall Vaccine Hesitancy, AI in Respiratory Care

Drug Topics

Check out this recap of articles published on our sister sites during the past week.

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Can MRIs ensure prostate cancer screening does more good than harm?

STAT

Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment  would do more harm than good.

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Pomelo Care acquires the Doula Network to offer hybrid maternity care model

Fierce Healthcare

Pomelo Care, a value-based virtual provider of maternity care, has acquired the Doula Network, now offering virtual and in-person maternity care. | The acquisition expands the company’s reach to more than 15 million covered lives, including more than 1 in 6 Medicaid beneficiaries nationally.

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Although AI Tools Are Advancing, Expert Says There Is a Need for More Tools Post-Diagnosis in Myeloma

Pharmacy Times

Although Madabhushi said there are emerging tools for clinical decision support, he said there is a greater need for tools further downstream in the post-diagnosis stages.

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US Adults’ Feelings Toward Vaccination Against Respiratory Illnesses

Drug Topics

The National Foundation for Infectious Diseases released a survey regarding the feelings of US adults toward influenza, COVID-19, RSV, and pneumococcal disease.

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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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CMS: Medicare Advantage, Part D premiums are stable for 2025

Fierce Healthcare

Medicare's open enrollment window opens in a few weeks, and the Centers for Medicare & Medicaid Services is offering a broad look at the landscape around Medicare Advantage and Part D before si | Medicare's open enrollment window opens in a few weeks, and the Centers for Medicare & Medicaid Services is offering a broad look at the landscape around Medicare Advantage and Part D before signups begin.

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FDA Approves Dupilumab as Add-On Maintenance Therapy For Adults With COPD

Pharmacy Times

Dupilumab is the first biologic medicine for patients with chronic obstructive pulmonary disease to be approved in the US.

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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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STAT+: Electronic health records giant Epic Systems sued over alleged monopolistic practices

STAT

The health data company Particle Health has filed an antitrust lawsuit against Epic Systems, alleging that the electronic health record vendor has used its control of patient data to thwart competition and undermine its business. The suit filed Monday in federal court in the Southern District of New York is a full-throated assault on Epic’s dominance in the market for electronic health records, charging that the privately held company has become a “behemoth” and a “mo

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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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Integrating SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis Feasible, Requires Improvements

Pharmacy Times

Although disease screening reached high-risk patients, uptake was low, necessitating additional incentive to participate in voluntary testing.

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Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy

Fierce Pharma

With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.

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STAT+: Can Anne Wojcicki save 23andMe?

STAT

Usually, introductory meetings with startup executives are perfunctory and fade to irrelevance within an hour. But I still remember the first moment I met 23andMe CEO and co-founder Anne Wojcicki in 2007. My editor at the time had set up a meeting between my reporting partner and I and Wojcicki, along with 23andMe co-founder Linda Avey, at an upscale sandwich shop on East 13th Street in New York City.

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Nonprofit hospitals received $37.4B in federal, local tax benefits in 2021, study finds

Fierce Healthcare

The nonprofit hospital sector’s tax exemptions provide billions in estimated benefits, but about half of those exemptions are enjoyed by just a couple hundred hospitals, according to a newly publis | The analysis, meant to serve as a guide for policymakers, noted that the tax breaks are "highly concentrated" and vary "substantially" from state to state.

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Dato-DXd Did Not Achieve Statistically Significant OS in Patients With Breast Cancer

Pharmacy Times

Compared with chemotherapy, datopotamab deruxtecan (Dato-DXd) did not achieve a statistically significant overall survival (OS) in patients with inoperable or metastatic HR+/HER2-low or negative breast cancer.

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Ipsen crosses EU finish line with Alagille syndrome drug

pharmaphorum

After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.

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STAT+: The little-known Chinese biotech whose cancer drug beat Keytruda has global ambitions

STAT

Recent headlines about a potent new immunotherapy have mostly focused on the U.S. company helping to develop it. Less attention has been paid to Akeso, a Chinese biotech that had kept a low profile until its drug bested Merck’s mega-blockbuster Keytruda in a late-stage lung cancer trial.  Now, Akeso’s leaders want you to know that its recent success isn’t a one-off.

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CMS sets Medicaid renewal compliance deadlines

Fierce Healthcare

The feds have set new deadlines for compliance with Medicaid renewal requirements given widespread enrollment concerns during the unwinding. | The feds have set new deadlines for compliance with Medicaid renewal requirements given widespread enrollment concerns during the unwinding.

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