Thu.Sep 26, 2024

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Experts support FDA's plan for biomarker-based restriction on PD-1 drugs in stomach cancer

Fierce Pharma

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

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Unpacking the Epic-Particle Health Dispute: When It Started, What’s Being Alleged & What It Means for the Industry

MedCity News

Following a months-long dispute, data platform Particle Health filed an antitrust lawsuit against Epic, alleging that the EHR giant is using its dominance in the market to prevent competition in the payer platform space. Particle believes the lawsuit is an “unprecedented challenge” to Epic’s market power, while Epic thinks the startup’s claims are “baseless.

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AstraZeneca’s Tagrisso follows up ASCO standing ovation with key lung cancer FDA nod

Fierce Pharma

In June, at the American Society of Clinical Oncology (ASCO) conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer (NSCLC) blockbuster Tag | In June at the ASCO conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer blockbuster Tagrisso, the presentation received a standing ovation.

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Personalize Patient Care with Confidence Through Efficient, HIPAA-Compliant Data Usage

MedCity News

Responsible procurement and handling of data and digital marketing insights by hospitals can generate useful information to improve patient wellness and operational efficiency without compromising compliance. The post Personalize Patient Care with Confidence Through Efficient, HIPAA-Compliant Data Usage 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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Roche looks to grow Gazyva's reach with phase 3 lupus nephritis win

Fierce Pharma

After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis. | In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thur

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Exercise Benefit in a Pill: BioAge Labs Goes Public, Raising More Than $200M for Clinical Trials

MedCity News

BioAge Labs’ lead drug candidate, azelaprag, is in Phase 2 testing in combination with Eli Lilly’s weight management medication Zepbound. The biotech’s oral drug activates a receptor it says can mimic certain biological effects of exercise. The post Exercise Benefit in a Pill: BioAge Labs Goes Public, Raising More Than $200M for Clinical Trials appeared first on MedCity News.

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How Health Systems Can Bridge Gaps in Health Equity

MedCity News

To effectively address health disparities, organizations must implement health equity strategies that target systemic barriers and root causes. Here are strategies that can help drive comprehensive, system-wide change. The post How Health Systems Can Bridge Gaps in Health Equity appeared first on MedCity News.

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Parenteral Drug Association is ensuring drug shortage effects are minimal in a post pandemic world

Fierce Pharma

In this insightful interview, Josh Eaton, Senior Director for Scientific and Regulatory Affairs at the Parental Drug Association (PDA), discusses the vital role of the organization in ensuring drug | Drug shortages aren’t just the effect of the pharmaceutical industry’s lack of preparedness. Learn about pandemic-driven drug shortages, regulatory changes, and PDA’s efforts to enhance pharmaceutical communication and ensure patients have vital medications they need.

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Vicebio raises $100m for vaccines and other bio financings

pharmaphorum

Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.

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Battle of the Budget: Employers vs. Rising Healthcare Costs

MedCity News

Don’t miss this opportunity to gain valuable knowledge and practical insights on how employers are addressing an increasingly complex healthcare budget landscape. The post Battle of the Budget: Employers vs. Rising Healthcare Costs appeared first on MedCity News.

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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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MSD hits a hurdle with its LAG-3 programme

pharmaphorum

MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac

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MedCity Pivot Podcast: How AI Can Help in Cancer

MedCity News

Dr. Timothy Showalter talks about how AI can be a powerful force in recommending treatment for cancer patients. He is Artera’s chief medical officer and the company has built a digital pathology tool for prostate cancer patients. The post MedCity Pivot Podcast: How AI Can Help in Cancer appeared first on MedCity News.

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Behind the rise BMS’ KarXT, the first new schizophrenia drug in decades

PharmaVoice

KarXT’s approval demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.

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BetterHelp, Talkiatry Collaborate To Offer Psychiatric Services to Employers

MedCity News

Through a new partnership, employees of BetterHelp’s employer clients can access Talkiatry’s psychiatry services on an in-network basis at no extra cost. The post BetterHelp, Talkiatry Collaborate To Offer Psychiatric Services to Employers appeared first on MedCity News.

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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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AZ gets sought-after lung cancer approval for Tagrisso

pharmaphorum

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

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Pharmaceutical Excellence Awards 2024: West Pharmaceutical Services 

Pharmaceutical Technology

West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.

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Mirai Bio launches with plan to help genetic med developers

pharmaphorum

Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.

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Oxford drug design secures funding to combat cystic fibrosis lung infections

PharmaTimes

£3m programme to accelerate new antimicrobial treatment

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

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Obesity drug developer BioAge raises $198m in IPO

pharmaphorum

BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.

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Sheffield A&E to implement life-saving HIV and hepatitis testing

PharmaTimes

New government scheme to offer routine opt-out blood tests

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Second Niemann-Pick approval brings more hope to patients

pharmaphorum

IntraBio claims FDA approval for its Aqneursa therapy for Niemann-Pick type C, the second new drug for the disease in four days

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Roivant’s magic trick: Finding the ‘weird-shaped’ pieces around Big Pharma’s cookie cutters

PharmaVoice

Roivant CEO Matt Gline leads the company on a unique path by placing bets on misfit drugs and technologies — and it’s working.

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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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Drug Solutions Podcast: Alternative Drug Delivery Methods for Biologics: Where Are We At?

PharmaTech

In this podcast episode, we discuss both the challenges of and the progress made so far by the biopharma industry toward non-parenteral means of delivering biologic drugs.

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WHO guidance aims to strengthen clinical trial ecosystem

European Pharmaceutical Review

New global guidance on best practices to improve clinical trials has been released by the World Health Organization (WHO). Fundamentally, the document offers approaches aimed at enhancing the design, conduct and oversight of clinical trials, to strengthen country-led R&D ecosystems. The guidance is relevant to clinical trials including pharmaceutical medicines, vaccines, behavioural and psychological interventions, preventive care, as well as digital and public health approaches and traditio

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Cell and Gene Therapy Production Facilities

PharmaTech

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.

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FDA Approves Osimertinib for Unresectable EGFR-Mutated Lung Cancer

Pharmacy Times

The decision is based on positive results from the phase 3 LAURA trial.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Oral Lipid-Based Formulations: Unlocking Value in Early-Stage Pharmaceutical Development

PharmaTech

Webinar Date/Time: Wed, Oct 16, 2024 11:00 AM EDT

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FDA Approves Tagrisso for Unresectable Stage III Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer

PharmExec

Tagrisso was approved under a Priority Review based on the pivotal LAURA Phase III trial in adults with unresectable stage III epidermal growth factor receptor-mutated non-small cell lung cancer.

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Bormioli Pharma Display at CPHI Milan to Include Low-Impact, Pharma-Grade Product Range

PharmaTech

The EcoPositive range, which comprises 50% of Bormioli Pharma’s current standard catalog and is composed of three distinct sustainability approaches, offers more than 3000 industrial solutions, in glass and plastic.

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LogiPharma USA 2024: Enhancing Cold Chain Insights

Pharmaceutical Commerce

A panel offers its perspective on bolstering the temperature monitoring and data sharing process.

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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