Sat.Jun 29, 2024 - Fri.Jul 05, 2024

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Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod

Fierce Pharma

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

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What Degree is Best For Medical Sales?

David Bagga

Medical Device Sales Academy What Degree is Best For Medical Sales? The healthcare industry, a significant driver of the economy and a key player in improving people’s lives, is poised for continued growth. This expansion is fueled by the increasing demand for healthcare services and tools, driven by an aging population and prevalent illnesses.

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‘Accidental’ media switch leads to CAR T therapy discovery

European Pharmaceutical Review

Altering the conditions that T cells are grown in can improve CAR T-cell therapy, US researchers have found. Discovered by chance, their new method has potential to treat solid cancer tumours more efficiently, according to the findings. Putting T cells on a keto diet [putting our T cells on a three-day ‘keto’ diet] showed reduced maturity at the end of the manufacturing process.

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Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

MedCity News

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Emergent BioSolutions bags $250M in contract modifications to help boost US supply of medical countermeasures

Fierce Pharma

With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.

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AstraZeneca files rival to Pemgarda for COVID PrEP

pharmaphorum

AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

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Why Are Primary Care Physicians Optimistic About AI?

MedCity News

Primary care physicians are generally pretty optimistic about AI’s potential to make care delivery more efficient, according to new survey results. In the past few years, automated dictation and scribing tools were the AI technologies that have been most impactful for primary care providers. The post Why Are Primary Care Physicians Optimistic About AI?

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BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey

Fierce Pharma

Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

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CHMP meeting highlights – June 2024

European Pharmaceutical Review

At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval. Recommendations for regulatory approval The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma. In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions.

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Sobi starts rolling FDA filing for chronic gout drug

pharmaphorum

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

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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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Mental Health Fraud Schemes: How to Protect Your Plan

MedCity News

By being aware of the latest schemes, health plan leaders can ensure their members have appropriate access to care while preventing bad actors from exploiting telehealth policies established during the pandemic. The post Mental Health Fraud Schemes: How to Protect Your Plan appeared first on MedCity News.

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Biden joins Sanders' campaign targeting Novo Nordisk, Eli Lilly's diabetes and obesity drug prices

Fierce Pharma

In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two h

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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid

Pharmaceutical Technology

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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

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Capitation Technology Drives Financial Viability in Value-Based Care Models

MedCity News

Finding a payment technology solution that is specifically designed for alternative payment models like capitation helps payers and providers achieve financial sustainability in a value-based system. The post Capitation Technology Drives Financial Viability in Value-Based Care Models appeared first on MedCity News.

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Sanofi and Regeneron's Dupixent scores in Europe as the first biologic to treat COPD

Fierce Pharma

After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week. | After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week.

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Pharma responds to 2024 UK General Election

European Pharmaceutical Review

Following the Labour Party’s win yesterday in the UK 2024 General Election, industry representatives have voiced their opinions on what this could mean for the future of the pharmaceutical industry under the new government. Association of the British Pharmaceutical Industry (ABPI) The new government now needs to hit the ground running and rapidly set out a clear, detailed plan” “During its campaign, Labour was right to single out the UK’s life sciences sector as a critical partner fo

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The power and potential of regenerative medicine

pharmaphorum

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

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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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Four Strategies Medicare Advantage Plans Can Implement to Mitigate Financial Pressures

MedCity News

Health plans must take a consistent, thoughtful approach to sustaining their business by managing costs without compromising member access to quality healthcare. The post Four Strategies Medicare Advantage Plans Can Implement to Mitigate Financial Pressures appeared first on MedCity News.

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J&J, Legend's Carvykti shows CAR-T can extend lives in multiple myeloma

Fierce Pharma

In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.

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Eisai and Bristol Myers Squibb terminate ADC development deal

Pharmaceutical Technology

Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).

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Beacon lights up with $170m for retinal disease gene therapy

pharmaphorum

Beacon Therapeutics raises $170m for a pivotal trial of its gene therapy for X-linked retinitis pigmentosa, an inherited cause of blindness

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Moderna Gets $176M From BARDA for Key Test of Bird Flu Vaccine

MedCity News

BARDA is contributing funding for a Phase 3 clinical test of a Moderna messenger RNA vaccine that could protect against the strains of bird flu virus now spreading in U.S. dairy cows. The Moderna vaccine is currently in Phase 1/2 testing. The post Moderna Gets $176M From BARDA for Key Test of Bird Flu Vaccine appeared first on MedCity News.

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Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara

Fierce Pharma

Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

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Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity

Pharmaceutical Technology

Fucaso, a BCMA CAR T-cell therapy, is co-developed by Innovent and IASO Bio and was approved to treat multiple myeloma in China last month.

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GSK goes all-in on CureVac’s mRNA vaccines

pharmaphorum

GSK has upgraded its longstanding alliance with CureVac on mRNA-based vaccines for respiratory infections, paying €400 million ($429 million) upfront for global rights to its influenza and COVID-19 jabs.

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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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Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration

MedCity News

Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes. The post Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration appeared first on MedCity News.

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US FTC ramps up patent crusade with investigation into Teva's inhaler IP: report

Fierce Pharma

While certain other drugmakers have relented in the face of the U.S. | The FTC has launched an investigation into Teva over the Israeli-American drug giant's refusal to remove roughly two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, The Washington Post first reported, citing confidential agency documents.

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In the rapidly shrinking COVID market, this company still sees opportunity

PharmaVoice

GeoVax is developing a next-gen COVID vaccine targeting a population that’s so far been elusive: immunocompromised patients.

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Lilly gets FDA OK for Alzheimer’s drug, cites cost advantage

pharmaphorum

Eli Lilly finally has FDA approval for its amyloid-busting Alzheimer’s disease therapy donanemab and will launch it at a cost it claims could deliver savings compared to a rival therapy from Eisai/Biogen.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time