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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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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Trending Sources

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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.

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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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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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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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‘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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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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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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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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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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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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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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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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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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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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Novavax and Gavi Settle Dispute Over Covid Vaccines Pact, Avoiding Arbitration

MedCity News

By settling now and agreeing to deferred payments over the next five years, Novavax avoids the risk of being responsible for a much bigger payout all at once. The arbitration hearing over the disputed vaccine purchase agreement with Gavi was scheduled for this summer.

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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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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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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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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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Tools for Better Data Interoperability Are Here — But Providers Aren’t Adopting Them

MedCity News

There are plenty tools and data sharing standards available to foster a more cohesive and integrated approach to healthcare interoperability. However, providers aren’t really adopting these tools, experts said during a recent panel.

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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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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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Pfizer’s ulcerative colitis drug Velsipity gets EU okay

pharmaphorum

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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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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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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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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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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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At ViVE 2024, Get a Glimpse of the State of Cybersecurity in Healthcare [Sponsored]

MedCity News

Mari Savickis, Vice President of Public Policy with CHIME, will be moderating a panel discussion as part of the Cybersecurity Pavilion at the ViVE 2024 event in Los Angeles, scheduled for February 25-28. She said her organization anticipates several developments addressing cybersecurity this year.

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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.

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Novo, Novartis, BMS and J&J win judge's blessing to combine arguments in upcoming IRA hearing

Fierce Pharma

Four major drugmakers are joining forces as they prepare to battle certain aspects of the Inflation Reduction Act (IRA) in court next month. | A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.

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Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

pharmaphorum

AstraZeneca’s Tagrisso is cleared by FDA for use alongside chemotherapy as a frontline therapy for EGFR-positive lung cancer (NSCLC)

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.