Fri.Sep 06, 2024

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GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decision

Fierce Pharma

GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. | On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.

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Can AI Help Fix Our Demographic Time Bomb?

MedCity News

By 2030, the U.S. expects shortages of 200,000 nurses and 124,000 physicians snd similar shortages are already being felt in the U.K. and elsewhere. Here’s how to build and train a modern healthcare workforce in the age of AI The post Can AI Help Fix Our Demographic Time Bomb? appeared first on MedCity News.

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Gilead's Trodelvy triplet underwhelms, but bolsters company's phase 3 lung cancer design: exec

Fierce Pharma

Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. | Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. But it looks like that win won’t come from a triplet regimen that combines the antibody-drug conjugate with Merck’s Keytruda and chemotherapy in newly diagnosed non-small cell lung cancer.

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GSK says Nucala hits the target in new COPD trial

pharmaphorum

GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.

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

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Fierce Pharma Asia—Astellas' plant closure, lab debut; China's probe into AstraZeneca staffers

Fierce Pharma

Astellas is closing a gene therapy manufacturing facility in South San Francisco. But, across the country, the company opened a new R&D center in Massachusetts. | Astellas is closing a gene therapy manufacturing facility in South San Francisco. But across the country, the company opened a new R&D center in Massachusetts. Chinese authorities detained several current or former AstraZeneca employees.

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Boom, Now Bust: Budget Cuts and Layoffs Take Hold in Public Health

MedCity News

Local health department staffing grew by about 19% from 2019 to 2022, according to a report from the National Association of County and City Health Officials that studied 2,512 of the nation’s roughly 3,300 local departments. But those jobs, and the safety net they provide for the people in the communities served, are vulnerable as the money dries up, The post Boom, Now Bust: Budget Cuts and Layoffs Take Hold in Public Health appeared first on MedCity News.

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Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

MedCity News

The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The full approval comes nearly a year after the Travere drug narrowly missed the main goal of its confirmatory study. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.

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FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment

Pharmaceutical Technology

The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.

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StartUPDATES: New Developments for Healthcare Startups

MedCity News

Check out news from Oral Genome, Carrot Fertility, Thatch, and The Perryman Group. The post StartUPDATES: New Developments for Healthcare Startups appeared first on MedCity News.

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BioAge's $100m IPO, and other biotech financings

pharmaphorum

Financings in the biotech sector this week include an IPO filing for BioAge and private rounds for eGenesis, Navigator, and Circle Pharma.

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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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How Data Feedback Can Aid Patient Experience in Healthcare

MedCity News

By actively and consistently collecting feedback, hospitals can gain rapid insights into critical areas, allowing them to track and measure patient satisfaction levels, and crucially to react to any dips in standards of care. The post How Data Feedback Can Aid Patient Experience in Healthcare appeared first on MedCity News.

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Lilly adds to genetic meds push with Genetic Leap alliance

pharmaphorum

Eli Lilly signs another genetic medicines deal, this time with Genetic Leap, a start-up that applies AI to the discovery of RNA-targeted drugs.

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The Need for Cross-Functional Teams and the Tools to Get You There

Dinamic OR

Enhancing Cross-Functional Collaboration with DinamicOR’s Surgical Back Table and Workflow Management App In today’s healthcare environment, cross-functional teams are becoming increasingly essential, especially in operating rooms (ORs) where staff shortages are a growing concern. The shift toward interdisciplinary collaboration isn’t just a trend—it’s a necessity.

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FDA approves Amneal and Shilpa’s oncology product BORUZU

Pharmaceutical Technology

The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Mayo Clinic Taps AI Startup to Improve MSK Care

MedCity News

Mayo Clinic recently launched a collaboration with Exer AI, a Denver-based startup. The AI company seeks to improve diagnosis and treatment for musculoskeletal and motion disorders wherever the patient is — whether that be in their provider’s office, their home or via telehealth appointment. The post Mayo Clinic Taps AI Startup to Improve MSK Care appeared first on MedCity News.

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Eli Lilly’s once-weekly insulin shows promise in phase 3 trials

PharmaTimes

New treatment could simplify diabetes management for millions

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Breaking Down the New FTC Ruling on Fake Reviews & Testimonials

Healthcare Success

On August 14, 2024, the Federal Trade Commission (FTC) introduced a rule banning fake reviews and misleading testimonials to improve marketing transparency and authenticity. As a healthcare organization, you already prioritize ethical practices and HIPAA compliance due to the nature of your business. It’s important to adapt to these new changes to maintain patient trust and remain competitive.

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Gene therapy trial facilitates major vision improvement

European Pharmaceutical Review

Results from a Phase I/II gene therapy trial have demonstrated that ATSN-101 enabled patients with a rare inherited disease to gain substantial, rapid improvement in their vision. Participants with Leber congenital amaurosis (LCA1) due to mutations in the GUCY2D gene were evaluated in the one-year clinical trial. Of the 15 participants, three were paediatric subjects.

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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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Nucala Significantly Reduces Moderate to Severe Exasperations in Chronic Obstructive Pulmonary Disease

PharmExec

Results from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful reduction in moderate/severe exacerbations of chronic obstructive pulmonary disease compared to placebo over 104 weeks.

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HDA 2024 Traceability Seminar: How Prepared Is Pharma for DSCSA Compliance?

Pharmaceutical Commerce

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption.

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Beyond the Birthrate: The Societal Costs of Maternal Mortality

PharmExec

Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.

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Rentschler Biopharma Unveils Lentiviral Vector Manufacturing Toolbox

Pharmaceutical Commerce

The enhancement—which complements the CDMO’s adeno-associated viral vector services—will be utilized at the company’s advanced therapies site in Stevenage, UK.

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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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Potential Treatment Against All COVID Variants

PharmExec

Texas Biomed announced that research shows that a certain monoclonal antibody treatment could treat all variants of COVID-19, including past, present, and future strains.

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Investment opportunities in atopic dermatitis may drive innovation

Pharmaceutical Technology

The atopic dermatitis market is facing increased growth, with a projected market value of $16.7bn by 2030 for the 7MM, according to GlobalData.

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FDA Approves Boruzu for Subcutaneous, Intravenous Administration for Multiple Myeloma, Mantle Cell Lymphoma

PharmExec

Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.

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Evotec partners X-Chem for tech-enabled drug discovery

Pharmaceutical Technology

German life science company Evotec has announced a collaboration with X-Chem to accelerate early-stage drug discovery-leveraging technology.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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Pharma Pulse 9/6/24: Gaps and Opportunities in Qualitative Systematic Reviews, Companies Grapple With Expanding Cyber Rules & more

PharmExec

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

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Meeting Adventitious Agent Testing Needs for Complex Modalities

PharmaTech

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

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Digital Protection: Q&A with Jeffrey Bernstein

PharmExec

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

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After failed FSGS bid, Travere wins full FDA approval for Filspari in IgAN

Pharmaceutical Technology

The company had focused its resources on Filspari’s launch in IgAN after the US FDA snubbed the therapy in another rare kidney disorder.

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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.