Sat.Oct 07, 2023 - Fri.Oct 13, 2023

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New FDA SaMD Guidance Will Bring Monumental Changes to Industry

PharmExec

A discussion of the impact the new FDA SaMD guidance, identifying the differences between companion apps and SaMD, and what to expect from this combination in the future.

FDA 105
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Gates Foundation spends $40M to boost mRNA vaccine production in Africa and beyond

Fierce Pharma

Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers. | Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers.

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Is Medicare Advantage a Failed Experiment? Experts Debate

MedCity News

Enrollment in Medicare Advantage is increasing, but the program has been drawing scrutiny from the government. Can the program be saved? One expert believes Medicare Advantage is a failed experiment. Another thinks that while the program has its flaws, it shows tremendous potential.

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CCC Releases AI-Enabled Affiliation Matching Software Powering Open Access Publication Modeling and Analysis for Publishers

Copyright Clearance Center

October 10, 2023 – Danvers, Mass. – CCC , the leading provider of Open Access (OA) workflow solutions, announces new data import capabilities and AI-enabled affiliation matching in its OA Agreement Intelligence modeling and analytics tool that provides publishers with a 360-degree view of disambiguated publication data to build accurate, transparent institutional offers regarding OA.

Training 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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An Evolving ‘Opinion’ Landscape: New Paths—and Synergies—for Pharma KOLs & DOLs

PharmExec

Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.

Pharma 119
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Novo Nordisk's unstoppable semaglutide clears kidney disease trial early on positive efficacy

Fierce Pharma

For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate. | For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.

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More Trending

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Roche multiple sclerosis subcutaneous injection: late-breaking data

European Pharmaceutical Review

Late-breaking data from Roche’s Phase III OCARINA II study have revealed that OCREVUS® (ocrelizumab) subcutaneous injection was comparable to IV infusion in providing near-complete suppression of MRI brain lesion activity over 24 weeks, for relapsing or primary progressive multiple sclerosis (RMS or PPMS) patients. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, which are thought to be a key contributor to myelin and axonal (nerve cell) damage, noted Roche.

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FDA Creates Advisory Committee on Digital Health Technologies

PharmaTech

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

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Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears

Fierce Pharma

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Ke | What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda.

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3 Questions This Healthcare Investor Finds Herself Asking Startups All The Time

MedCity News

At HLTH, General Catalyst Principal Candace Richardson discussed some of the questions she frequently asks startups during investment meetings. Some of these include “Do you stratify your outcomes data by different populations to ensure your model works well for everyone?” and “Is serving Medicaid populations on your roadmap?

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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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Biopharma Stock Check: Market Review and Outlook

PharmExec

Exploring the pharma and biotech financing, M&A, and stock market pictures through the first half of 2023—and implications for the future, as market challenges continue to weigh heavily in senior management decision-making.

Marketing 104
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Life Sciences Innovation Day – Accelerating Digital Transformation Ambition

European Pharmaceutical Review

Schneider Electric, a leader in digital transformation, energy management and automation, has announced the speaker lineup for its exclusive event, Life Sciences Innovation Day – Accelerating Digital Transformation Ambition. Set at the world-renowned Silverstone F1 Racetrack on 18 October 2023, it promises to be a day of immersive insights and top rate networking.

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Bayer christens $250M cell therapy 'launch facility' in Berkeley

Fierce Pharma

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. | Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.

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Pfizer Expands in Immunology With FDA Approval of New Ulcerative Colitis Drug

MedCity News

Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.

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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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Why are haemophilia gene therapies so expensive?

Pharmaceutical Technology

Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.

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Roche to Develop Two Novel RNA-targeted Programs from Ionis for CNS Diseases

PharmaTech

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

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Pfizer inks another EpiPen antitrust settlement, this one worth $50M

Fierce Pharma

Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief m | Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.

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CVS Exec: We’re Going To Find Out if Blue Shield of California’s New Drug Model Will Lower Costs

MedCity News

Blue Shield of California recently switched up its pharmacy benefit model by distributing responsibilities to several different vendors. The model has the potential to increase drug costs, but it remains to be seen, according to Creagh Milford, SVP of retail health at CVS Health.

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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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Follicular lymphoma BTK inhibitor recommended by CHMP

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of BRUKINSA ® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab. BeiGene’s anti-cancer treatment is indicated for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.

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Soft Implant Uses AI to Deliver Drugs Despite Fibrous Encapsulation

Medgadget

Scientists at the University of Galway in Ireland and MIT have collaborated to create a soft robotic implant that can work to fight fibrotic encapsulation and deliver drugs despite the presence of fibrous scar tissue. The device, which the researchers have termed the FibroSensing Dynamic Soft Reservoir (FSDSR), is designed to reside in the body for extended periods and deliver drugs.

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After Novo's Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

Fierce Pharma

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. | Based on the inclusion criteria for Novo Nordisk’s chronic kidney disease trial, dialysis bigwig DaVita believes there may only be “limited application” of the study’s findings to the overall CKD population.

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Digital Hospital of the Future Streamlines Care to Reduce Burdens on Clinicians

MedCity News

The most successful implementations of digital solutions offer value propositions on both sides of the equation — they create value for the patient and family, while also making the clinician’s job easier and more enjoyable by saving time and eliminating ancillary duties.

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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 Growing Shift to Point-of-Care Advertising in Virtual Healthcare

LEVO Health

The healthcare landscape is undergoing a seismic shift, with telemedicine playing a pivotal role. Alongside this, point-of-care advertising is emerging as a powerful tool to deliver timely and relevant information to healthcare professionals during their interactions with patients. This form of advertising is becoming especially crucial in the age of virtual care, ensuring that physicians have the right information at their fingertips.

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FDA lifts clinical hold on PepGen’s myotonic dystrophy type 1 candidate

Pharmaceutical Technology

The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.

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After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat

Fierce Pharma

Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partn | The FDA shot down Alvotech and Teva's biosimilar candidate to Johnson & Johnson's Stelara over “certain deficiencies” uncovered by the FDA during a reinspection of the company's factory in Iceland earlier this year.

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Patient-Centric Digital Transformation: Rethinking Remote Monitoring for Comprehensive Care [Sponsored]

MedCity News

A recent webinar sponsored by AVIA Health and Seamless MD examined how health systems use remote patient monitoring beyond the usual chronic condition applications, including surgical prep and recovery, women’s health, and more.

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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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A Blueprint for Balance

PharmExec

Stephen Rivera, vice president, global technical accounting advisory services and policy, Johnson & Johnson, capitalizes on his lively personality—and a courageous career journey—to bring people together to shape the future of biopharma.

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What Does the Metaverse Mean to Pharma?

PM360

Is the metaverse a worthwhile investment for pharma? Is the metaverse even a worthwhile investment for Meta? In July, Meta’s second-quarter earnings report revealed its Reality Labs unit, which is responsible for developing its virtual reality (VR) and augmented reality (AR) technologies, lost $3.7 billion—and $21.3 billion in total over the last year.

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Amylyx's ALS drug Albrioza rebuffed by EU regulator—again

Fierce Pharma

Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. | Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

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From Promise to Impact: The Evolution of AI in Medical Imaging for Population Health and ROI

MedCity News

The ultimate challenge for the broader adoption of AI in medical imaging remains the same: demonstrating to healthcare institutions that it provides a clear ROI.

Medical 121
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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.