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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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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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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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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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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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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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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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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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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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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Lykos CEO steps down after MDMA is rejected by FDA

pharmaphorum

The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.

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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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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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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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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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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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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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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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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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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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What 3 layoff stories reveal about pharma’s troubles

PharmaVoice

The factors driving the industry’s layoffs — and what could help turn the tide.

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

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FDA Approves Sparsentan, With Data Indicating Slowing of Kidney Function Decline in IgA Nephropathy

Pharmacy Times

Full traditional approval follows accelerated approval of the medication last year.

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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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Study: Shingles Could Increase Risk of Cognitive Decline

Pharmacy Times

Individuals with a history of shingles was significantly and independently connected with a 20% higher risk of for subjective cognitive decline.

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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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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Navigating Multiple Myeloma Care: Balancing CAR T-Cell Therapy and Immunotherapy

Pharmacy Times

The evolving treatment landscape for multiple myeloma includes debates on the timing and effectiveness of CAR T-cell therapy and quadruple immunotherapy regimens.

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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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What to Expect As New CMS Hospital Transparency Requirements Take Effect in 2025

Pharmacy Times

New transparency initiatives will go into effect on January 1, 2025, building off previous actions by the Centers of Medicare and Medicaid Services.

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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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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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A