Sat.Apr 15, 2023 - Fri.Apr 21, 2023

article thumbnail

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Fierce Pharma

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

FDA 364
article thumbnail

A CMO’s quest to tackle infectious diseases leads him to an eye condition that’s often overlooked

PharmaVoice

How an “international” childhood sent Dr. José Trevejo, Tarsus’s chief medical officer, on a mission to fight infectious diseases.

Leads 98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Nanoparticles Deliver mRNA Therapy to the Lungs

Medgadget

Researchers at MIT have developed lipid nanoparticles that are highly efficient at delivering mRNA therapies to lung cells. Getting therapeutic agents into the lungs can be challenging, but there are a variety of medical challenges that could be addressed by efficiently targeting lung cells with nanoparticle technologies. These latest particles are highly efficient at delivering mRNA which can then encode therapeutically useful proteins in the lungs.

article thumbnail

US FDA makes EUA changes to Pfizer-BioNTech and Moderna Covid-19 vaccines

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5 strains can now be utilised for all doses administered to those aged six months and above.

FDA 133
article thumbnail

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.

article thumbnail

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy

Fierce Pharma

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35

363
363
article thumbnail

Innovaccer Launches Conversational AI Assistant to Help Health System, Payer Execs

MedCity News

Innovaccer launched a new product called Sara, a conversational AI assistant designed to help executives at health systems and payers make better use of their data. It allows executives can ask complex questions about their organization’s patients or members and get immediate answers on clinical, financial or operational metrics.

Patients 134

More Trending

article thumbnail

Twist Bioscience and Astellas team up for antibody discovery

Pharmaceutical Technology

Twist Bioscience and Astellas Pharma have entered a collaboration to help the latter to discover antibodies for immunotherapies. This is the third collaboration between the two companies. In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression.

Sales 105
article thumbnail

'The Top Line': How Pfizer became the first in Big Pharma history to break $100B in sales, plus this week's headlines

Fierce Pharma

'The Top Line': How Pfizer became the first in Big Pharma history to break $100B in sales, plus this week's headlines tcarey Thu, 04/20/2023 - 14:46

Sales 293
article thumbnail

Tech Is Changing Physical Therapy Treatment, but We Still Need a Human Touch

MedCity News

By combining in-home and virtual care, we can meet patients literally where they are. More importantly, we can improve outcomes, reduce costs and help patients get back to a normal life while giving therapists the flexibility and opportunity to provide more customized care for their patients.

Patients 131
article thumbnail

Merck to develop mAb through $10.8b acquisition

European Pharmaceutical Review

Merck & Co. Inc has agreed to acquire Prometheus Biosciences for $10.8 billion. The agreement is set to help advance PRA023, a novel humanised monoclonal antibody (mAb), developed by Prometheus. Its chosen indications are ulcerative colitis (UC) and Crohn’s disease (CD) and other autoimmune conditions. Prometheus is a clinical-stage biotechnology company.

Safety 105
article thumbnail

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

article thumbnail

SAB secures FDA breakthrough therapy status for influenza immunotherapy

Pharmaceutical Technology

SAB Biotherapeutics has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for SAB-176, an investigational immunotherapy to treat influenza. The newly granted status allows SAB to speed up the development and review of SAB-176, which is currently being studied for use in post-exposure prophylaxis for Type A and Type B influenza in high-risk patients, including those with anti-viral resistant strains.

article thumbnail

J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows

Fierce Pharma

J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows aliu Wed, 04/19/2023 - 09:10

261
261
article thumbnail

Glen Tullman’s 5 Predictions for Healthcare’s Future

MedCity News

Glen Tullman — CEO of care navigation company Transcarent, as well as former CEO of Allscripts and Livongo — discussed what he thinks the future of healthcare will look like during the HIMSS conference in Chicago. He laid out five predictions, including an increased focus on consumer expectations and more investment in AI.

article thumbnail

J&J Launches $50M Multiple Sclerosis Collaboration with Pipeline Therapeutics

PharmExec

J&J's Janssen Pharmaceutica NV collaborates with Pipeline Therapeutics in a $50 million licensing deal for oral MS drug PIPE-307, with potential earnings of up to $1 billion for Pipeline.

103
103
article thumbnail

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

article thumbnail

Merck agrees to acquire Prometheus Biosciences for $10.8bn

Pharmaceutical Technology

Merck has signed a definitive agreement to buy clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn, strengthening its immunology pipeline. The company will buy all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary. Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases.

article thumbnail

Big Pharmas finally strike with GSK, Merck acquisitions, signaling accelerating pace of M&A

Fierce Pharma

Big Pharmas finally strike with GSK, Merck acquisitions, signaling accelerating pace of M&A aarmstrong Tue, 04/18/2023 - 09:47

Pharma 246
article thumbnail

What is the Next Chapter for FDA’s Accelerated Approval’s in Oncology?

MedCity News

Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion.

FDA 118
article thumbnail

NICE recommends therapy duo for advanced leukaemia

European Pharmaceutical Review

Imbruvica ® (ibrutinib) plus venetoclax has been recommended as an option for untreated chronic lymphocytic leukaemia (CLL) in adults by the National Institute for Health and Care Excellence (NICE). Ibrutinib is a tyrosine kinase inhibitor (TKI) therapy. By blocking Bruton’s tyrosine kinase (BTK), which is needed by cancer cells to multiply and spread, ibrutinib could help stop them from growing and dividing.

article thumbnail

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.

article thumbnail

Moderna and IBM to explore quantum computing and AI for mRNA research

Pharmaceutical Technology

Moderna has signed an agreement with IBM to explore quantum computing and generative artificial intelligence (AI) for advancing and expediting its mRNA research. Moderna will gain access to IBM’s quantum computing systems, an emerging technology that harnesses quantum mechanics for solving complex problems that cannot be handled efficiently by classical computers.

article thumbnail

AbbVie's Qulipta gains edge on Pfizer's Nurtec with FDA approval to prevent chronic migraines

Fierce Pharma

AbbVie's Qulipta gains edge on Pfizer's Nurtec with FDA approval to prevent chronic migraines zbecker Tue, 04/18/2023 - 11:09

FDA 245
article thumbnail

What Are the Best Practices in Implementing AI in Healthcare?

MedCity News

With AI being so new, there are some best practices for companies to follow when bringing it into healthcare. This includes partnerships and understanding the shortcomings of AI, several experts said during a session at the HIMSS 2023 conference.

article thumbnail

Oral drug reduces treatment-resistant migraine frequency

European Pharmaceutical Review

Participants with episodic migraines who have had no success with other preventive drugs had an average of four fewer days with migraine per month when given oral atogepant. This is according to results from a preliminary study, of which the abstract will be presented at the American Academy of Neurology’s 75th Annual Meeting held between April 22-27 2023.

article thumbnail

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

article thumbnail

Incyte receives EC approval for Opzelura to treat non-segmental vitiligo

Pharmaceutical Technology

Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.

article thumbnail

As Bayer's CEO switch nears, activist investor pushes harder for breakup, board changes

Fierce Pharma

As Bayer's CEO switch nears, activist investor pushes harder for breakup, board changes fkansteiner Fri, 04/21/2023 - 10:25

255
255
article thumbnail

Delivering Better Outcomes with a Modern Patient Financial Experience

MedCity News

Modernizing the financial experience is about more than payment: it requires a comprehensive approach that includes pre-registration activities and extending the streamlined digital experience into the point of care.

Patients 118
article thumbnail

Could ATR-FT-IR spectroscopy become ‘gold standard’ for heparin analysis?

European Pharmaceutical Review

A new, cost-effective method of analysing pharmaceutical heparin using attenuated total reflectance fourier-transform infrared (ATR-FT-IR) spectroscopy combined with multivariate analysis has been reported in a paper. ATR-FTIR coupled with principal component analysis (PCA) was able to differentiate all glycosaminoglycan (GAG) types in a similar way to solution-based FTIR, but with significantly simpler sample preparation, the authors stated.

article thumbnail

How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

article thumbnail

FDA pushes Daiichi Sankyo’s quizartinib approval date by three months

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.

article thumbnail

In Pfizer's $43B acquisition of Seagen, the biotech's patience paid off

Fierce Pharma

In Pfizer's $43B acquisition of Seagen, the biotech's patience paid off kdunleavy Mon, 04/17/2023 - 11:34

272
272
article thumbnail

Why Is Health Tech Still Not Personalized?

MedCity News

Health technologies are often built based on the “reference man” and frequently don’t take other demographics into account. It shouldn’t be this way, experts argued on a panel Thursday at the HIMSS 2023 conference.

article thumbnail

CCC Hosting Panel at The London Book Fair on Reading the Data Compass: The Guiding Role of Metadata in an Increasingly Complex Scholarly Research Ecosystem

Copyright Clearance Center

April 18, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, is hosting a panel discussion on “Reading the Data Compass: The Guiding Role of Metadata in an Increasingly Complex Scholarly Research Ecosystem” during the Research & Scholarly Publishing Forum at The London Book Fair on 20 April, 11:40 -12:10 in the Olympia Theatre.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time