Mon.Jun 10, 2024

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GSK notches another Zantac win as plaintiff drops case in Illinois

Fierce Pharma

As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. | Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday.

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Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment

MedCity News

Physical and mental health are inextricably intertwined — senior-focused primary care can help bridge the treatment gap The post Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment appeared first on MedCity News.

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GSK, attempting to stage Blenrep comeback, bids adieu to combo studies with SpringWorks' Ogsiveo

Fierce Pharma

Despite the recent approval of SpringWorks Therapeutics’ Ogsiveo, GSK is calling it quits on prior plans to wed the Pfizer spinout’s drug with its withdrawn cancer med Blenrep. | SpringWorks has received a notice of termination on an amended collaboration and licensing deal with GSK from 2022. Under the updated pact, GSK and SpringWorks were working together to develop and potentially market combinations of Blenrep and Ogsiveo in multiple myeloma.

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Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial

MedCity News

An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses. The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial 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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FDA accepts Eisai's subcutaneous Leqembi filing, sets January 25 decision date

Fierce Pharma

About a month after Eisai initiated a rolling FDA application for its subcutaneous form of Leqembi, the U.S. agency has accepted the filing. | The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025.

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Pelago Launches Inpatient Centers of Excellence Network

MedCity News

Pelago’s new Inpatient Centers of Excellence network offers Pelago members access to a nationwide network of inpatient substance use disorder treatment centers. The network includes organizations like the Recovery Centers of America and Banyan Treatment Centers. The post Pelago Launches Inpatient Centers of Excellence Network appeared first on MedCity News.

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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New paediatric blood test to prevent sudden death from hereditary heart condition

PharmaTimes

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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Rapid Translation of Therapeutic Discoveries into the Clinic through Purposeful Collaboration

MedCity News

How academia and biotech can team up to bring impactful new drug therapies to patients faster The post Rapid Translation of Therapeutic Discoveries into the Clinic through Purposeful Collaboration appeared first on MedCity News.

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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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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Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program

MedCity News

Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion. The post Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program appeared first on MedCity News.

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Last places on FDA START rare disease programme filled

pharmaphorum

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna, Myrtelle, and Calico Life Sciences.

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New Startup Launches to Reduce Medical Practices’ HR Burden

MedCity News

Stitch PEO — a startup built at Redesign Health — officially launched and announced that it has raised $8.75 million in seed funding. The company is a professional employer organization for independent medical practices, designed to improve recruiting, hiring, onboarding, and other human resources processes. The post New Startup Launches to Reduce Medical Practices’ HR Burden appeared first on MedCity News.

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Mastering Sales Conversations with Customers

Integrity Solutions

We’re all familiar with the stereotype of the over-the-top, pushy, unscrupulous salesperson. They’re always in selling mode, always hustling, always doing whatever it takes to close the deal and win at all costs, regardless of whether they’re actually addressing (or even understanding) the customer’s needs. There’s no real sales conversation or dialogue.

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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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Drug Shortage Reports Emphasize Continuing Problems

PharmaTech

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

FDA 104
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Pharma Pulse 6/10/24: Sustainability in Clinical Trials, Merck Bets on AI Drug-Design Partnerships & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA OKs wider use of Almirall’s actinic keratosis drug

pharmaphorum

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri. First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can be a precursor to skin cancer.

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Innovative radioligand manufacturing facility inaugurated

European Pharmaceutical Review

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Orano Med (a subsidiary of the Orano Group)’s ATLab (Alpha Therapy Laboratory) facility in Brownsburg, near Indianapolis, Indiana, US, is set to help address the production and supply challenges of lead-212 radioligand therapies.

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

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Boehringer, Lilly face off in MASH at EASL

pharmaphorum

Eli Lilly's tirzepatide and Boehringer Ingelheim's survodutide grab the spotlight at EASL with new phase 2 data in metabolic dysfunction-associated steatohepatitis (MASH)

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Five-year data from Genentech SMA study released

European Pharmaceutical Review

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). What did the FIREFISH extension study find? The study found that after five years without treatment, 91 percent of children were alive.

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Aligos Therapeutics gets grant for patent granted for compounds treating diseases and conditions

Pharmaceutical Technology

Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.

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Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

PharmaTimes

Accounting for 4% of all cases, kidney cancer is currently the sixth most common cancer diagnosed in the UK

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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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Risk adjusted net present value: What is the current valuation of Sensei Biotherapeutics’s SNS-101?

Pharmaceutical Technology

SNS-101 is a monoclonal antibody commercialized by Sensei Biotherapeutics, with a leading Phase II program in Non-Small Cell Lung Cancer.

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CDER Announces Emerging Drug Safety Technology Meeting Program

PharmaTech

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

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Risk adjusted net present value: What is the current valuation of Pyxis Oncology’s PYX-201?

Pharmaceutical Technology

PYX-201 is a monoclonal antibody conjugated commercialized by Pyxis Oncology, with a leading Phase I program in Thyroid Cancer.

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Moderna says COVID/flu shot clears phase 3 hurdle

pharmaphorum

Moderna says it has become the first company in the pharma sector with phase 3 data on a combined vaccine for both COVID-19 and influenza

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Study Finds Alterations in Functional Connectivity of Brain Regions in Adolescents With Internet Addiction

Pharmacy Times

The authors noted that these networks have a significant role in intellectual ability, physical coordination, working memory, emotional processing, and overall mental health.

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Four key trends in the clinical trial supply chain

Pharmaceutical Technology

Clinical trial supply chains have experienced significant changes in recent years. We identify the four key trends.

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FTC Finalizes Changes to Health Breach Notification Rule: What Digital Health Companies and App Developers Need to Know

Nixon Gwilt Law

The Federal Trade Commission (FTC) finalized changes to the Health Breach Notification Rule ( HBNR ), clarifying its applicability to health apps and similar technologies, including those that are not subject to HIPAA. In 2023, FTC began enforcing the HBNR in earnest, with an expanded interpretation of their authority under the HBNR. In the 2024 Final Rule (the 2024 Final Rule), the agency conforms the HBNR to this expanded interpretation, clarifying its breadth for industry and the public.

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Determination of Shelf-Life from Stability Data: From Replicates or from Averages?

PharmaTech

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

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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