Fierce Pharma

SEPTEMBER 23, 2024

Despite being thrown off its rhythm twice already, Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the compan | Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the company’s talc products caused users to develop cancer.

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MedCity News

SEPTEMBER 23, 2024

Biohaven’s troriluzole, which initially failed a pivotal study in spinocerebellar ataxia, is now being readied for an FDA submission in this rare neurodegenerative disease. The turnabout is based on positive results from a new study that incorporated real-world evidence. The post Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 23, 2024

For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet. | Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February, punting the complaint back to a lower Texas court.

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MedCity News

SEPTEMBER 23, 2024

The biopharmaceutical industry clearly isn’t going anywhere, but we’ve been in a downward business cycle. We’ve learned a lot from the pandemic and have adopted novel approaches to development and this current economic challenge will also inform us. In the meantime, adopting these strategies can de-risk your development programs. The post Navigating Economic Uncertainty in Biopharma appeared first on MedCity News.

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Biopharma 105

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Fierce Pharma

SEPTEMBER 23, 2024

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

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MedCity News

SEPTEMBER 23, 2024

Many new tech solutions, such as wearables and algorithms, have emerged in recent years to address the country’s heart disease problem. While it’s easy to get excited about technology’s potential to improve cardiac care, there are a few things that healthcare leaders must keep in mind, according to Dr. Sumeet Chugh, director of the Heart Institute and director of AI in medicine at Cedars-Sinai.

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MedCity News

SEPTEMBER 23, 2024

In exchange for federal money, hospitals would wipe out billions of dollars of patient debt and adopt new standards to shield patients from crippling bills. The post How North Carolina Made Its Hospitals Do Something About Medical Debt appeared first on MedCity News.

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Fierce Pharma

SEPTEMBER 23, 2024

After several years spent honing its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer. | After several years spent building partnerships to hone its robotic cell therapy manufacturing system, Multiply Labs has snared its first collaboration with a major cell therapy developer: Legend Biotech.

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Manufacturing 154

Integrity Solutions

SEPTEMBER 23, 2024

Sales enablement has become an integral component of the modern sales organization, yet there is still confusion around what sales enablement actually is and, crucially, how to really make it deliver results for your salespeople and your business. As sales leaders grapple with continual volatility and complexity in the selling ecosystem, they’ve increasingly turned to sales enablement strategies to help improve sales outcomes and drive growth more efficiently.

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pharmaphorum

SEPTEMBER 23, 2024

RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation

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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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Pharmaceutical Technology

SEPTEMBER 23, 2024

Download our free, extensive list of the leading Active Pharmaceutical Ingredients and Intermediates companies and suppliers today.

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pharmaphorum

SEPTEMBER 23, 2024

Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.

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FDA 114

MedCity News

SEPTEMBER 23, 2024

To conduct meaningful research, we must be sure to view these studies through patients’ eyes. The patient perspective — in all its diversity — must be embedded into clinical trials from the very start. The post Tackling Global Obesity: The New, Holistic Frontier for Clinical Trials appeared first on MedCity News.

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Patients 82

pharmaphorum

SEPTEMBER 23, 2024

Johnson & Johnson's long-running effort to put litigation claiming its talc products caused cancer has continued with a third attempt to place a subsidiary company into bankruptcy. Red River Talc LLC was set up specifically to resolve the thousands of claims related to ovarian cancer arising from cosmetic talc litigation, separated from the group's core business and armed with billions of dollars in settlement money to provide compensation to alleged victims.

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Pharmaceutical Technology

SEPTEMBER 23, 2024

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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FDA 96

pharmaphorum

SEPTEMBER 23, 2024

Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight. The FDA has approved Sarclisa (isatuximab) as a first-line therapy for blood cancer multiple myeloma as a combination regimen alongside bortezomib, lenalidomide, and dexamethasone (VRd), for people who are not eligible for an autologous stem cell transplant (ASCT).

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FDA 74

Pharmaceutical Technology

SEPTEMBER 23, 2024

View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.

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Pharmaceutical Commerce

SEPTEMBER 23, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Mark Karhoff, supply chain & DSCSA consultant, National Association of Boards of Pharmacy, discusses insurances to the upcoming DSCSA deadline.

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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.

Safety

Pharmaceutical Technology

SEPTEMBER 23, 2024

Discover Lyell Immunopharma's groundbreaking patent for EGFR-derived polypeptides, enhancing cancer treatment through innovative nucleic acid technologies and engineered T cells.

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Engineering 52

PharmExec

SEPTEMBER 23, 2024

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

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FDA Medical 52

Pharmaceutical Commerce

SEPTEMBER 23, 2024

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

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FDA Medical 52

PharmExec

SEPTEMBER 23, 2024

Brian Hillberdink, EVP, LEO Pharma and President of LEO Pharma's US affiliate, discusses their approach to orphan drug development, challenges and opportunities adapting to the US market, and more.

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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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Pharmaceutical Commerce

SEPTEMBER 23, 2024

In a final part of his interview with Pharma Commerce Editor Nicholas Saraceno, Kevin MacDonald, Bluesight’s Co-founder and CEO, explains the amount of time it takes to see a reduction in annualized drug spend, and offers estimates in terms of percent savings.

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PharmaTech

SEPTEMBER 23, 2024

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

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Pharmaceutical Technology

SEPTEMBER 23, 2024

Discover Telesis Bio Inc.'s groundbreaking patent for synthesizing specific DNA sequences. Learn how their innovative method enhances genetic engineering and biotechnology.

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Engineering 52

PharmExec

SEPTEMBER 23, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Pharmaceutical Technology

SEPTEMBER 23, 2024

Pancreatic cancer is resistant to conventional therapies, but cutting-edge research may improve survival rates and patient quality of life.

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Patients 52

PharmExec

SEPTEMBER 23, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Pharma 52

PharmaVoice

SEPTEMBER 23, 2024

A new report examines the patient reach efforts of 20 of the world’s largest pharma companies in low- and middle-income countries.

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PharmExec

SEPTEMBER 23, 2024

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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