Mon.Nov 11, 2024

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Overweight, Obesity Linked with Increased Long COVID Risk in Pediatric Patients

Drug Topics

Research has found that children and young adults with overweight or obesity may be at a significantly increased risk of developing long COVID.

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How Pharmacists Can Make an Impact When Treating Dedifferentiated Liposarcoma With Brigimadlin

Pharmacy Times

Brigimadlin is a new oral MDM2-p53 antagonist under investigation as a potential first-line therapy to improve outcomes for patients with advanced or metastatic dedifferentiated liposarcoma.

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Trending Sources

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STAT+: Schizophrenia drug AbbVie picked up in $9 billion acquisition fails in key trials

STAT

AbbVie said Monday that its experimental treatment for schizophrenia failed to significantly help patients in two trials, a blow to the company, which got the drug through its recent $9 billion acquisition of Cerevel Therapeutics. In Phase 2 studies, patients on different doses of the drug, called emraclidine, did not experience significant improvements on a test called the Positive and Negative Syndrome Scale (PANSS) compared with the placebo group.

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FDA Approves Obecabtagene Autoleucel for Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Pharmacy Times

The regulatory approval corresponds with positive safety and efficacy data from the FELIX trial.

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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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Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod

Fierce Pharma

Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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STAT+: The end of 23andMe’s drug discovery dream

STAT

23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research. In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic da

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More Trending

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STAT+: Children’s Hospital Los Angeles tests generative AI to translate discharge notes into Spanish

STAT

When patients and their families leave the emergency room, they’re usually clutching a sheaf of papers: Called discharge notes, they contain important instructions about how to care for themselves and when to follow up with a doctor. If patients don’t speak English, though, they may leave with directions they can’t understand.  At most hospitals, it takes between hours and days to translate discharge notes for outpatients who have limited English proficiency.

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Oracle to collaborate with Meharry Medical College on innovation hub, wellness center in Nashville

Fierce Healthcare

Meharry Medical College in Nashville, Tennessee, is collaborating with Oracle on a new project to advance healthcare access, innovation and education in Middle Tennessee and beyond. | The organizations plan to establish a joint research collaborative focused on precision medicine and health informatics, a health innovation hub and a community care and wellness center in Nashville.

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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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With US launch progressing, ARS inks another licensing deal for epinephrine spray Neffy worth up to $465M

Fierce Pharma

Although ARS Pharmaceuticals’ approval for its epinephrine nasal spray came later than expected, the company ultimately received a thumbs up from the FDA in August and is now moving fast to expand | ARS Pharmaceuticals said that Denmark’s ALK-Abelló is paying $145 million upfront for the rights to market Neffy in Europe, Canada and “other geographies outside of the U.S.

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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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Cardiovascular health disparities persist in puzzling ways, studies find

STAT

Last week’s election results may signal political winds sweeping attention away from diversity, equity, and inclusion, but new research papers again make the case that people in different socioeconomic groups have differing health outcomes of concern.

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Zongertinib: A Promising New TKI for HER2-Mutated NSCLC

Pharmacy Times

If approved, zongertinib may be a new first-line oral tyrosine kinase inhibitor (TKI) for patients with HER2-mutated non-small cell lung cancer (NSCLC), a transformative step in TKI drug development.

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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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Semaglutide Improves Liver Fibrosis in Patients with Metabolic Dysfunction-Associated Steatohepatitis

Pharmacy Times

Glucagon-like peptide-1 agonists have increasingly showed potential for treating liver fibrosis in patients, which disproportionately affects those who are overweight or have obesity.

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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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The evolving role of AI in drug submission and approval: An expert perspective

pharmaphorum

Discover an expert perspective on how artificial intelligence is transforming the drug submission and approval process in the pharmaceutical industry. Explore the evolving role of AI in drug development.

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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

The FDA Law Blog

By Deborah L. Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.

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Advantage BMS as AbbVie drug fails schizophrenia trials

pharmaphorum

AbbVie's $8.7bn play for Cerevel looks like a poor bet as its lead schizophrenia drug flunks two phase 2 trials, but which rival stands to benefit?

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Astrana plots to expand its footprint with $745M deal for Prospect Health businesses

Fierce Healthcare

Healthcare company Astrana Health plans to acquire certain businesses and assets of Prospect Health System in a $745 million deal that will expand its provider care network. | Healthcare company Astrana Health plans to acquire certain businesses and assets of Prospect Health System in a $745 million deal to expand its provider care network.

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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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Lumateperone Demonstrates Positive Efficacy for Schizophrenia Relapse Prevention

Pharmacy Times

In the trial, lumateperone had a significantly longer time to relapse in patients treated compared to placebo.

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Moderna’s mRESVIA vaccine gains Health Canada approval

Pharmaceutical Technology

Moderna has received Health Canada's approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.

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CMS commences formal review for Topical Oxygen Therapy coverage

Pharmafile

11 November 2024 AOTI, INC. (AIM: AOTI), a medical technology group focussed on the durable healing of wounds and prevention of amputations, is pleased to note that the Centers for Medicare and Medicaid Services (CMS), through its Durable Medical Equipment (DME) Medicare Administrative Contractors (MACs), has scheduled a public Contractor Advisory Committee (CAC) meeting.

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Unicycive eyes June FDA verdict for hyperphosphataemia drug

pharmaphorum

FDA starts review of Unicycive's drug for hyperphosphataemia in patients with chronic kidney disease on dialysis, aiming to improve on onerous phosphate binder therapy

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Theramex receives recommendation for YSELTY in Scotland

Pharmafile

Theramex, a dedicated women’s health company, have announced that the Scottish Medicines Consortium (SMC) have recommended YSELTY (linzagolix) for the treatment of moderate or severe symptoms of uterine fibroids (UFs) in adult women of reproductive age. The decision from the SMC will see YSELTY available on the NHS across Scotland. Dr Sigi Joseph, co-founder of The […] The post Theramex receives recommendation for YSELTY in Scotland appeared first on Pharmafile.

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ACO Reach program savings grew larger in 2023. NAACOS is angling for the model's extension

Fierce Healthcare

Accountable care organizations in the ACO Reach program can claim credit for saving the Centers for Medicare & Medicaid Services (CMS) hundreds of millions of dollars | CMS released favorable savings results for ACO REACH Model participants, as industry group NAACOS begins to push for the program's extension through 2030.

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NHS England hopes to save thousands of lives with pill that helps smokers quit

The Guardian - Pharmaceutical Industry

Experts say once-a-day varenicline tablet reduces nicotine cravings and side-effects from cutting out tobacco Hundreds of thousands of smokers will be given a pill that increases people’s chances of quitting, in a move that NHS bosses believe will save thousands of lives. About 85,000 people a year in England will be offered the chance to use varenicline, a once-a-day tablet that experts say is as effective as vapes at helping people to kick the habit.

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Major payers saw mixed results in Q3. Here's a look at how each fared

Fierce Healthcare

The third quarter of 2023 was another mixed bag for major insurers as they continue to grapple with significant headwinds. | The third quarter of 2023 was another mixed bag for major insurers as they continue to grapple with significant headwinds.

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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Autolus bags FDA approval for leukaemia cell therapy

pharmaphorum

Autolus gets its first product approval, an FDA green light for anti-CD19 CAR-T Aucatzyl for B-cell acute lymphoblastic leukaemia

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Assertio fires back at activist investor's 'baseless allegations' over Rolvedon

Fierce Pharma

Four months after calling for the resignation of four board members from Assertio Holdings, New York investment advisory firm Buxton Helmsley Group has flipped its long equity position into a short | Answering allegations from activist investor Buxton Helmsley that it misled investors about its acquisition of Spectrum Pharmaceuticals and its cancer drug Rolvedon, Assertio called the claims "baseless.

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Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute

BioPharm

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.

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Can you take trazodone and Lexapro?

The Checkup by Singlecare

Finding the right medication to manage a mental health condition is difficult, and it can take some trial and error to settle on an effective treatment plan. Two commonly prescribed medications for various mental health conditions are trazodone and Lexapro. As a brand-name prescription drug, Lexapro is FDA -approved to treat major depressive disorder and anxiety disorders.

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Budget Announcement Prompts UK Medicines Manufacturing Skills Centre to Emphasize Need for Skills Development

BioPharm

Chancellor of the Exchequer, Rachel Reeves, has announced a £520 million (US$675 million) investment for manufacturing capacity in the United Kingdom, prompting academic and industry leaders to point out that funds should be used to train personnel.

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Wegovy sulfur burps: Why they happen and how to treat them

The Checkup by Singlecare

If you’re using Wegovy (semaglutide) for weight loss, there’s a small chance you may unexpectedly experience sulfur-tasting burps. This discomfort can catch you off guard and leave you wondering why it’s happening. While uncommon, this side effect can disrupt your daily life, making you hesitant to socialize or enjoy meals with others. Fortunately, there are ways to manage these bothersome sulfur burps.

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