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Intra-Cellular's unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia

Fierce Pharma

Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.

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Disc maps out US filing for porphyria drug bitopertin

pharmaphorum

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.

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Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

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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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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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Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs

MedCity News

The Novo Nordisk/Ascendis partnership’s lead program is once-monthly injectable semaglutide for type 2 diabetes and obesity. This product candidate will be developed with Ascendis Pharma technology that has already yielded two FDA-approved products with longer dosing intervals. The post Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs appeared first on MedCity News.

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ReferralMD Named to AVIA Marketplace’s 2024 Top Conversational AI Companies

Referral MD

MT. PLEASANT, S.C. , Nov. 1, 2024 /PRNewswire-PRWeb/ — ReferralMD, a leader in healthcare technology solutions, announced today that it was recognized as a 2024 Top Company in Conversational AI upon the conclusion of extensive research and company outreach by AVIA Marketplace, the leading digital health marketplace. ReferralMD offers a comprehensive platform that seamlessly integrates with Electronic Health Records (EHR), Practice Management, and Scheduling systems, automating time-consu

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3 Types of Startups that Healthcare Leaders Want to See More Of

MedCity News

During HLTH, I spoke with some investors and digital health executives about the types of startups that they haven’t encountered yet — but would like to. The post 3 Types of Startups that Healthcare Leaders Want to See More Of appeared first on MedCity News.

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From neurosurgery to focused ultrasound: Not if, but when

pharmaphorum

Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult

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A sickle cell cure exists. But patients need more than just gene therapy.

PharmaVoice

Almost a year after two historic approvals, Pfizer is pulling a sickle cell disease treatment from the market, and the outlook for patients feels shakier. But there’s still hope in the pipeline.

Patients 101
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Vertex's Casgevy breaks ground with 1st commercial patient infusions as company readies another major launch for 2025

Fierce Pharma

With new approvals on the horizon and the closely watched Casgevy launch picking up steam in sickle cell disease and beta thalassemia, “there has never been a more exciting time to be at Vertex,” c | With its first Casgevy revenues in the books, Vertex lifted its full-year sales outlook as it turns its attention to two product launches in 2025, including an expected new entrant in the pain market.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Northwestern and Case Western Reserve universities develop Huntington’s therapy

Pharmaceutical Technology

Researchers from Northwestern and Case Western Reserve universities have developed a polymer therapeutic to treat Huntington's disease.

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How to Align Primary Care With Behavioral Health

MedCity News

Reimbursement models that align primary care with behavioral health offer low-income provider organizations serving rural Americans and other vulnerable populations an opportunity to enhance coordination and improve outcomes while generating sorely needed revenue. The post How to Align Primary Care With Behavioral Health appeared first on MedCity News.

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Lilly touts new Kisunla regimen that reduces side effects

pharmaphorum

Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi

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CEO with type 1 diabetes works to deliver ‘world’s first’ functional cure

PharmaVoice

Sernova’s technology helped type 1 diabetes patients achieve insulin independence in early- and mid-stage trials.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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BioNTech reports surprising COVID vaccine sales in Q3 but tempers expectations for annual sales

Fierce Pharma

BioNTech reported surprisingly strong sales of its COVID-1 | BioNTech reported surprisingly strong sales of its COVID-19 vaccine in the third quarter. Despite the performance, the company expects to be at the lower end of its revenue guidance window for the year of between €2.5 billion to €3.1 billion.

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Novel nanoemulsion-based delivery of antimycobacterial drug

European Pharmaceutical Review

A paper has a described the first reported use of nanoemulsions as a novel delivery vehicle for the oral drug bedaquline (BDQ) “with high loading efficiency as a liquid dosage form”, according to the authors. The researchers explained that in recent decades, the industry has placed significant focus on lipid-based nanocarrier formulations for oral drug delivery.

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What’s Next for Psychedelic Medicines?

MedCity News

After the FDA delayed the approval of MDMA-assisted therapy for PTSD, there’s still a way forward for psychedelic medicines, experts said at HLTH. The post What’s Next for Psychedelic Medicines? appeared first on MedCity News.

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NICE backs first ophthalmic bevacizumab for NHS use

pharmaphorum

Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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FDA grants fast track status to FELIQS’s FLQ-101 to prevent ROP

Pharmaceutical Technology

The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP).

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'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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Report: Medicare Part D Premiums Rise an Average of 11% Nationwide

Pharmaceutical Commerce

Analysis finds that while basic Part D coverage costs have decreased by 4%, mid- and high-tier plans have seen hikes of 4% and 21%, respectively.

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Why AI Governance Is the Number 1 Issue on This Health System Exec’s Mind

MedCity News

Jason Hill, Ochsner Health’s innovation officer, said he goes to sleep most nights and wakes up most morning worried about one thing: the state of generative AI governance in healthcare. To him, providers and other healthcare organizations are in dire need of frameworks to ensure their AI tools are safe and perform well over time. The post Why AI Governance Is the Number 1 Issue on This Health System Exec’s Mind appeared first on MedCity News.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Novartis gets FDA okay for frontline use of Scemblix in CML

pharmaphorum

Novartis says FDA approval for frontline use of its leukaemia drug Scemblix will boost the number of eligible patients four-fold, as it hunts blockbuster sales

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Biogen and Neomorph enter molecular glue degrader deal

Pharmaceutical Technology

Biogen and Neomorph have partnered to discover and develop molecular glue degraders for treating Alzheimer’s and other rare conditions.

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Incyte wins injunction to block launch of Sun Pharma's JAK inhibitor Leqselvi

Fierce Pharma

Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.

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The Top 100 Women-Led Businesses in Massachusetts in 2024

Copyright Clearance Center

The Women’s Edge and Globe Magazine celebrate the state’s leading companies and nonprofit organizations led by women.

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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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Beam’s Base-Editing Sickle Cell Therapy Shows Early Promise, But a Fatality Overshadows Results

MedCity News

The death wasn’t due to Beam Therapeutics’ sickle cell disease therapy, BEAM-101, but was instead attributed to the preconditioning treatment needed before the genetic medicine is infused. A different Beam program in preclinical development could avoid the need for toxic preconditioning; data from both programs will be presented during the upcoming American Society of Hematology annual meeting.

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Lexicon's type 1 diabetes drug voted down by FDA adcomm

pharmaphorum

FDA advisors vote against Lexicon Pharma's type 1 diabetes and chronic kidney disease therapy sotagliflozin ahead of December verdict

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Backlash builds against Novo’s Catalent takeover

PharmaVoice

Roche recently joined naysayers who argue the deal threatens competition in the burgeoning weight loss and diabetes drug market.

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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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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A