Sat.Feb 17, 2024 - Fri.Feb 23, 2024

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AI in Pharma: Navigating New Frontiers in Drug Discovery and Development

Pharma IQ

Bringing a new drug to market typically takes a decade or more and approximately US$2.5 billion. However, new technology, including AI, can dramatically shorten the drug discovery process and reduce t.

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Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

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Enhancing Patient Care: 4 Strategies for Life Sciences Companies

Salesforce

For many people, a sudden tingling in the leg or a feeling of numbness in the arm isn’t too much cause for alarm. The tingling or the numbness goes away after a little while, and they go on with their lives. But for Brooke Eby, an abrupt limp on her way to a conference one day ultimately led to a diagnosis of amyotrophic lateral sclerosis (ALS) at the age of 33.

Patients 137
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‘Nation-State’ Cyberattack Hits Change Healthcare, Disrupting Pharmacy Services Across the Country

MedCity News

Pharmacies across the country are facing disruptions following a cyberattack on Change Healthcare — which is owned by Optum, a subsidiary of UnitedHealth Group. In a filing with the SEC, UnitedHealth stated that the unauthorized party that gained access to Change Healthcare’s systems was a “suspected nation-state associated cyber security threat actor.

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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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The AI-Powered Path to Revolutionising Rare Disease Research

Pharma IQ

Explore how AI/ML can accelerate rare disease research and clinical trials, by enhancing inclusivity and efficiency, to deliver new drugs and therapeutics to patients. With insights from Dr. Harsha Ra.

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Travere's Filspari, J&J's Carvykti win support from CHMP in blitz of positive recommendations

Fierce Pharma

A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.

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Brain-Computer Interface (BCI) Technology: Revolutionizing Healthcare with Brain-Controlled Technology

MedCity News

From diagnostics to treatment methodologies, BCI technology can unravel new dimensions of understanding and intervention, fundamentally altering the landscape of patient care.

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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

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To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align

Fierce Pharma

Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.

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CCC to Host Town Hall on Copyright, Artificial Intelligence, and the Training of Large Language Models

Copyright Clearance Center

February 22, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will host the Town Hall event “The Heart of the Matter: Copyright, AI Training and LLMs” via LinkedIn Live on Thursday, 29 February, 11:00 EST/16:00 GMT. A panel of legal experts including Prof. Daniel Gervais , Vanderbilt University Law School, and Prof.

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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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Telehealth Advocates: HHS Has Done Its Bit on Expanding OUD Treatment; DEA Needs to Step Up

MedCity News

HHS recently released a final rule that allows practitioners in Opioid Treatment Programs to start patients on methadone or buprenorphine via telehealth. However, the final rule does not apply to the broader range of providers, leading telehealth advocates to call for additional changes from the DEA.

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FDA starts review of Argenx drug in rare disease CIDP

pharmaphorum

The FDA has said it plans to deliver a decision in June on the use of Argenx’ Vyvgart Hytrulo in rare autoimmune disease chronic inflammatory demyelinating polyneuropathy (CIDP).

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After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

Fierce Pharma

As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new owner in the U.S. | As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor a new U.S. owner in Rigel Pharmaceuticals.

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For Moderna, COVID vaccines were a ‘proof of concept’ — now comes the big test

PharmaVoice

Following Moderna’s COVID-19 vaccine success, therapeutics head Dr. Kyle Holen discusses scaling mRNA development to bring candidates to the finish line in oncology and more.

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

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Meet the Marketplace Providers Are Using to Overcome the ‘Notorious Challenge’ of Radiology AI Adoption

MedCity News

About 80% of all FDA-approved healthcare AI applications are related to radiology — but due to a massive workforce shortage, radiologists don’t have the time to explore, choose, validate and implement the tools available to them. Some providers are using a radiology AI marketplace called CARPL to address this problem, including Massachusetts General Hospital and University Hospitals.

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AbbVie’s 24-hour Parkinson’s therapy to roll out on NHS

pharmaphorum

Around 1,000 people with Parkinson’s in England will be able to access treatment with AbbVie’s Produodopa, the first therapy delivered by a 24-hour subcutaneous infusion pump

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Novo Nordisk, Eli Lilly lead industrywide sales surge in Q4

Fierce Pharma

In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.

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EGFR inhibitor could provide major advance in lung cancer

European Pharmaceutical Review

Small molecule treatment TAGRISSO ® (osimertinib) demonstrated a “statistically significant and highly clinically meaningful improvement” in progression-free survival (PFS) for Stage III lung cancer patients, AstraZeneca has confirmed. This was established from positive high-level results seen in the LAURA Phase III trial. The data was based on observations from patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemor

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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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Driving Accessibility in HealthTech: 3 Things Founders should Consider for Thoughtful AI Implementation in 2024

MedCity News

The benefits of artificial intelligence in healthcare are apparent. With careful planning, we can ensure that these developments benefit everyone, leaving no one behind in the goal of a healthier and more equal future.

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Analyzing PCSK9 Inhibitor Use in Adults With Cardiovascular Disease

Pharmaceutical Commerce

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

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Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany

Fierce Pharma

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. | Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08 billion) into an expansion of its production facility in Pfaffenhofen an der Ilm, Germany.

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Value and potential of IoT and AI for chronic diseases treatment

PharmaVoice

A significant growth is predicted for both AI and IoT in healthcare. By 2030, the AI market is expected to reach $187.95 billion USD, while the IoT market is projected to climb even higher to $312.7 billion USD.

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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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MedCity FemFwd: What Male Birth Control Means for Women’s Health

MedCity News

In this episode, we’re joined by Régine Sitruk-Ware, a distinguished scientist at the Population Council’s Center for Biomedical Research (CBR), and Chelsea Polis, senior scientist of epidemiology at CBR. They talk about the effect upcoming male birth control products could have on women’s health.

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Bavarian Nordic gets swift EU review of chikungunya shot

pharmaphorum

Bavarian Nordic will get an accelerated review of its chikungunya vaccine CHIKV VLP at the EMA, as it tries to chase down a lead held by rival Valneva. The Danish pharma group said it is planning to file for approval of its vaccine in the first half of this year, adding the EU regulator’s human medicine committee, the CHMP, has said it will cut the review time from 210 to 150 days under its accelerated assessment procedure.

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Touting commercial and R&D progress, AstraZeneca hikes CEO Pascal Soriot's pay to nearly £17M

Fierce Pharma

AstraZeneca, having surpassed its long-term $45 billion revenue goal last year, has handsomely rewarded its chief executive. | AstraZeneca CEO Pascal Soriot’s compensation package makes him the current top contender for 2023’s highest-paid pharma CEO in Europe. Still, as in years past, not everyone is pleased with Soriot’s 2023 windfall.

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FDA Accepts Biologics License Application for Datopotamab Deruxtecan

Pharmaceutical Commerce

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

FDA 101
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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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HealthSnap Snags $25M to Help Providers Launch & Scale RPM Programs

MedCity News

HealthSnap closed a $25 million Series B funding round led by Sands Capital. The Miami-based company seeks to help providers better care for a rapidly aging and chronically ill population through its remote patient monitoring platform.

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New era for cell therapy as FDA OKs first for solid tumours

pharmaphorum

Iovance Biotherapeutics has become the first company to win FDA approval for a cell therapy used to treat a solid tumour, Amtagvi for melanoma

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Congressional lawmakers strike back at Biden admin's 'march-in' proposal to corral drug costs

Fierce Pharma

As the Biden administration’s exploration of “march-in rights" draws support from powerful entities like the Federal Trade Commission (FTC), a group of lawmakers on both sides of the aisle have war | As the Biden administration’s exploration of “march-in rights" draws support from powerful entities like the Federal Trade Commission, a small group of lawmakers on both sides of the aisle have warned the approach could “hamstring” U.S. innovation.

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Analysis reveals “superior efficacy” of long-acting injectable HIV treatment

European Pharmaceutical Review

An interim analysis of a Phase III trial has demonstrated superior efficacy of the long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva ( cabotegravir + rilpivirine), for HIV patients with a history of ART adherence challenges. “The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” shared Dr Kimberly Smith, MPH, Head of R&D at ViiV Healt

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time