Sat.Nov 02, 2024 - Fri.Nov 08, 2024

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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.

Medical 309
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AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges? 

MedCity News

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise. The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges? appeared first on MedCity News.

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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

Sales 124
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First-of-a-kind EU approval granted for eosinophilic esophagitis medicine

European Pharmaceutical Review

Dupixent (dupilumab) has been approved by the European Medicines Agency (EMA) as the first treatment for young children with eosinophilic esophagitis in the EU. This authorisation is based on Phase III data which found that 68 percent of children aged one to 11 years given Dupixent (dupilumab) achieved histological disease remission at 16 weeks. This result was maintained for up to one year.

Medicine 105
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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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Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Fierce Pharma

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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WTW: There’s A Disconnect Between Employers and Employees on Wellbeing Programs

MedCity News

Employers are prioritizing mental wellbeing programs, but employees say they need financial wellbeing support, according to a survey from WTW. The post WTW: There’s A Disconnect Between Employers and Employees on Wellbeing Programs appeared first on MedCity News.

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Top 20 biopharmas’ market cap rises 2% in Q3 2024 amid flurry of drug approvals

Pharmaceutical Technology

The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.

Biopharma 105
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Novavax coughs up $123.8M to settle COVID vaccine supply dispute with UK

Fierce Pharma

Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.

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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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Journey slips on FDA approval of rosacea therapy

pharmaphorum

Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.

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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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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.

Patients 125
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Syndax inks $350M deal with Royalty Pharma for funding to launch 2 new drugs

Fierce Pharma

With its first FDA approval coming in August and a sec | With its first FDA approval coming in August and a second expected next month, these are exhilarating days for 19-year-old Syndax Pharmaceuticals as it transforms into a commercial enterprise. To help foot the bill to launch its approved graft-versus-host disease drug Niktimvo and the expected launch of its leukemia treatment revumenib, Syndax has struck a $350 million deal with Royalty Pharma.

Pharma 296
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Patients Across the Country Deserve Better Access to Healthcare

MedCity News

By focusing on integrating care teams, expanding community programs, and addressing SDoH through policy reform, we can create a healthcare system that serves all patients — especially those most in need. The post Patients Across the Country Deserve Better Access to Healthcare appeared first on MedCity News.

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Novo sheds kidney drug licensed for $1.3bn a year ago

pharmaphorum

Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3 billion after it missed the mark in a chronic kidney disease (CKD) trial.The Danish group bought rights to ocedurenone, an oral non-steroidal mineralocorticoid receptor antagonist (nsMRA), from the Singapore biotech in October 2023 as a companion to its GLP-1-based therapies for reducing cardiovascular risk and kidney disease in people with diabetes and obesity.

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

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AstraZeneca and Amgen’s Tezspire succeeds in Phase III nasal polyps trial

Pharmaceutical Technology

A Phase III trial with the companies’ monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps met its primary endpoint.

Patients 105
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AstraZeneca stock tanks over fears of expanding China fraud probe

Fierce Pharma

AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a local report fueled fears of a potentially escalating insurance fraud investigation in China. | AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a report fueled fears of a potentially escalating insurance fraud investigation in China.

Insurance 295
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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.

Pharma 112
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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.

Medicine 109
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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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DBV Technologies’ stock slides as financial woes worsens

Pharmaceutical Technology

The company reported that it does not have sufficient cash reserves to operate for the next 12 months, can only fund operations into Q1 2025.

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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.

Patients 293
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4 Things Employers Should Know About Psychedelic Medicines

MedCity News

During a panel discussion at the Behavioral Health Tech conference, experts shared the promise psychedelic medicines hold for mental health and why employers may want to consider offering them as a workplace benefit. The post 4 Things Employers Should Know About Psychedelic Medicines appeared first on MedCity News.

Medicine 116
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AZ confirms China president has been detained

pharmaphorum

AstraZeneca has revealed that its top executive in China, Leon Wang, has been detained by Chinese authorities

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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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EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients

Pharmaceutical Technology

The EMA has granted approval for Sanofi/Regeneron’s Dupixent (dupilumab) to treat EoE in children as young as one.

Patients 105
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Fierce Pharma Asia—AstraZeneca's China fallout; Pfizer's $1B plan in China; Incyte-Sun JAK dispute

Fierce Pharma

AstraZeneca's China president has been detained by Chinese authorities amid investigation into illegal importation and improper collection of patient data. | AstraZeneca confirmed its China president has been detained by Chinese authorities. Pfizer plans to invest $1 billion in China in the next five years. Sun Pharma's JAK inhibitor Leqselvi was slapped with an injunction in a lawsuit with Incyte.

Pharma 301
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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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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

Medical 105
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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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Ultra-processed food is causing a boom for obesity drug Ozempic

Pharmaceutical Technology

The seemingly inexorable rise in global obesity is being reflected in the sales of diabetes and weight-loss drugs, including Ozempic.

Food 93
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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.

Pharma 288
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Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition

MedCity News

CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development. The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition appeared first on MedCity News.

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NHS Wales partners with Illumina on genomics drive

pharmaphorum

Wales has extended a scheme to harness the power of genomics to improve cancer care and prevention via an alliance with gene-sequencing giant Illumina.

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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