Sat.Dec 14, 2024 - Fri.Dec 20, 2024

article thumbnail

Unlocking AI Explainability for Trustworthy Healthcare

MedCity News

AI should augment, not replace, human provider expertise. Explainability empowers healthcare professionals to work in tandem with AI, ensuring that patients receive the most accurate and informed care. The post Unlocking AI Explainability for Trustworthy Healthcare appeared first on MedCity News.

article thumbnail

FDA rejects J&J's subcutaneous Rybrevant filing and AZ's full approval bid for Andexxa

Fierce Pharma

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.

FDA 303
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

Mesoblast finally pushes GvHD cell therapy over finish line

pharmaphorum

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

FDA 96
article thumbnail

PM360 Presents the 2024 Innovators

PM360

Established in 2012, PM360 introduced the first-ever issue focused entirely on our industrys latest innovations. Categories explore every sector of the healthcare industry, from life sciences to marketing. PM360 would like to welcome you to the new age of innovation with our illuminating Innovations Issue. This yearly special issue has served as your go-to guide for the most interesting advancements in our industry over the past 13 years, by featuring a focussed view of 11 different areas in hea

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

Startup SiteOne Secures $100M to Forge Ahead With Novel Non-Opioid Pain Meds

MedCity News

SiteOne Therapeutics develops drugs that target sodium channels, the wiring in the body that transmits pain signals. Because SiteOnes targets are located in the peripheral nervous system, they should not pose the same addiction risks as opioids, which hit receptors in the central nervous system. The post Startup SiteOne Secures $100M to Forge Ahead With Novel Non-Opioid Pain Meds appeared first on MedCity News.

Medical 106
article thumbnail

After studies flag possible link between Novo's Ozempic and rare eye disorder, Danish agency calls for probe

Fierce Pharma

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

Medicine 241

More Trending

article thumbnail

HUMANIZING HEALTHCARE – EXPERT on Call: CHANGING THE WAY HEALTH IS EXPERIENCED. The Culture-Forward Revolution

PM360

In the high-stakes world of healthcare, the relationship between pharmaceutical advertising and the people it aims to reach is at a critical crossroads. For far too long, underserved communities have seen little in these ads that speak to their lives let alone their unique healthcare journeys. Now more than ever, the industry is recognizing that diversity, equity, and inclusion (DEI) are not just add-ons, but essential elements that define successful, meaningful campaigns.

article thumbnail

Healthcare Organizations Can, and Should, Provide Continuous Patient Care with the Right Technology

MedCity News

Now, more than ever, healthcare organizations must strive to innovate to ensure continuous patient care delivery while keeping medical staff safe. The post Healthcare Organizations Can, and Should, Provide Continuous Patient Carewith the Right Technology appeared first on MedCity News.

article thumbnail

Novartis to shutter 2 MorphoSys sites, lay off 330 staffers in post-buyout consolidation

Fierce Pharma

In a move that follows an increasingly common trend in biopharma M&A, Novartis is shedding sites and staffers from the German cancer biotech it acquired earlier this year. | Novartis confirmed Thursday that its closing down MorphoSys sites in Munich and Boston in a move thats expected to result in around 330 layoffs. The company made the decision in November as it looks to integrate all portfolio activities into Novartis.

Biopharma 221
article thumbnail

Novo completes $16.5bn takeover of Catalent

pharmaphorum

Novo Holdings' $16.

82
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

Novo Nordisk takes a hit as CagriSema underperforms in weight loss

Pharmaceutical Technology

Novo Nordisk has announced positive results from its Phase III trial of CagriSema but fell short of a previously promised 25% weight loss.

64
article thumbnail

WellTheory Announces Women’s Health Program to Address Hormonal Conditions

MedCity News

WellTheory has launched a new program that will address the link between autoimmune disease and hormone imbalances. The post WellTheory Announces Womens Health Program to Address Hormonal Conditions appeared first on MedCity News.

100
100
article thumbnail

Checkpoint Therapeutics takes on Merck's mighty Keytruda with FDA approval for Unloxcyt in skin cancer

Fierce Pharma

Another checkpoint inhibitor has entered the fray, as Checkpoint Therapeutics has passed the FDAs checkpoint with its PD-L1 inhibitor cosibelimab. | Another checkpoint inhibitor has entered the fray, as Checkpoint Therapeutics has passed the FDAs checkpoint with its PD-L1 inhibitor cosibelimab.

FDA 250
article thumbnail

Neuralink rival Precision raises $102m, and other financings

pharmaphorum

Neuralink rival Precision Neurosciences raises $102m for its brain-computer interface tech, plus financings for Redesign, DeepLife, TG0 and Tuva.

74
article thumbnail

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

article thumbnail

FDA confirms end of Eli Lilly’s tirzepatide shortage after re-evaluation

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has stood by an earlier decision confirming that the tirzepatide shortage is over.

article thumbnail

Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder

MedCity News

Neurocrine Biosciences Crenessity is now FDA approved for treating classic congenital adrenal hyperplasia (CAH), a rare and potentially fatal endocrine disorder. The approval comes with a priority review voucher, which Neurocrine could sell for around $150 million. The post Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder appeared first on MedCity News.

FDA 99
article thumbnail

Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancer

Fierce Pharma

Following in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. | Following in the footsteps of Pfizer, Roche and Takeda, another ALK inhibitor has made its belated entry into the U.S. The FDA nod comes four years after its initial approval in China.

FDA 201
article thumbnail

Novo Holdings leads $100m round for novel painkiller biotech

pharmaphorum

SiteOne Therapeutics has completed a $100 million third-round financing that will support clinical trials of its non-opioid painkiller.

Leads 74
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

Astellas and Sangamo sign capsid deal for neurological diseases

Pharmaceutical Technology

Astellas Pharma and Sangamo have signed a licence agreement for neurotropic adeno-associated virus (AAV) capsid, STAC-BBB.

Pharma 64
article thumbnail

TraumaCare.AI shaping the future of critical care with AI-powered innovation

MedCity News

Discover the cutting-edge AI software that empowers trauma and critical care teams with real-time, data-driven insights. The post TraumaCare.AI shaping the future of critical care with AI-powered innovation appeared first on MedCity News.

91
article thumbnail

Cozadd's coda: Jazz unveils succession plan as longtime CEO and co-founder plots retirement

Fierce Pharma

Its the end of an era at Jazz Pharmaceuticals as the drugmakers co-founder and CEO, Bruce Cozadd, eyes his exit after nearly 22 years with the companysome 15 of which were spent at the helm. | Current helmsman Bruce Cozadd plans to retire from his role at Jazz Pharmaceuticals in the next 12 months, the company said Monday. Jazz aims to complete its search for a CEO successor by the end of 2025, after which Cozadd will stay on board as the drugmaker's board chair.

article thumbnail

Bristol Myers Squibb licenses amyloid-beta antibody programme

European Pharmaceutical Review

Bristol Myers Squibb has licensed an amyloid-beta antibody programme from BioArctic AB. The PyroGlutamate-amyloid-beta (PyroGlu-A) programme includes novel antibodies (BAN1503 and BAN2803). These target a truncated, pyroglutamate modified form of amyloid-beta. BAN2803 utilises a technology platform that optimises biologic drug delivery past the blood brain barrier, BioArctic noted.

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

Ottimo raises $140m for its PD-1/VEGF cancer drug

pharmaphorum

Ottimo raises $140m for PD-1 and VEGF-targeting jankistomig, which the startup says is differentiated from bispecific antibodies in the class.

63
article thumbnail

Closing the Gap: Advancing Precision Oncology Through Education and Collaboration

MedCity News

How top-to-bottom collaboration can alleviate hurdles and help increase equitable access to the most effective treatments for all cancer patients. The post Closing the Gap: Advancing Precision Oncology Through Education and Collaboration appeared first on MedCity News.

article thumbnail

Pfizer expects $1B hit from IRA's Part D redesign and no major M&A in 2025

Fierce Pharma

After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.< | After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.

212
212
article thumbnail

Abera and Orexo partner for vaccine powder formulations

Pharmaceutical Technology

Abera and Orexo have entered a partnership to develop and test the powder formulations of the formers vaccine candidates.

66
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

10 of our most read articles of 2024

PharmaVoice

The high drama of an election year, industry layoffs, patent cliff strategies and other key trends that shaped pharma in 2024.

Pharma 59
article thumbnail

The AI Advantage: Reimagining the Future of Drug Development 

MedCity News

Like any other tool, understanding the right problem to apply it to is the difference between success and failure. Addressing a problem is never just about technology; its always about people, processes, and technology. The post The AI Advantage: Reimagining the Future of Drug Development appeared first on MedCity News.

article thumbnail

Fierce Pharma - Untitled Article

Fierce Pharma

Perhaps PD-1 inhibitors just arent for ovarian cancer after all. | Merck's and GSK's similar overall survival setbacks suggest that PD-1 inhibitors may not be for ovarian cancer after all.

186
186
article thumbnail

FDA approves Ionis’ TRYNGOLZA for FCS treatment

Pharmaceutical Technology

The US FDA has approved Ionis' TRYNGOLZA (olezarsen) as an adjunct to diet for reducing triglyceride levels in the adult population with FCS

FDA 59
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time