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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.

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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.

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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.

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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

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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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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.

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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.

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MSD eyes June verdict for paediatric RSV antibody

pharmaphorum

The FDA has started a review of MSD's RSV antibody clesrovimab, a potential rival to Beyfortus, with a verdict due in the middle of next year

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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.

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Novo Nordisk invests $1.2bn in new Denmark facility

Pharmaceutical Technology

Construction has already begun on the Ozempic-producers new Denmark production facility and 40,000m2 warehouse.

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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.

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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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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.

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Novo completes $16.5bn takeover of Catalent

pharmaphorum

Novo Holdings' $16.

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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.

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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.

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

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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.

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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.

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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.

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CSL receives positive opinion for garadacimab in hereditary angioedema

PharmaTimes

New treatment could revolutionise care for HAE patients

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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.

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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.

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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.

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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.

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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.

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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

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How to Elevate Your Content Marketing to Thought Leadership Marketing

Healthcare Success

What does it really take to stay ahead in healthcare? The answer is thought leadership. Heres why: Its about more than just quick winsits a long-term strategy. Collaborating with the right experts and crafting a powerful network of insights can pave the way for lasting brand awareness, credibility, trust, and sustainable growth. Together, these can position your business for success and help it stand the test of time.

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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.

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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.

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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.

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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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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.

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Beckley Psytech announces positive results for ELE-101 in depression trial

PharmaTimes

Phase 2a study shows promising antidepressant effects

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CTO Europe 2024: keep the burden of trials away from patients, say experts

Pharmaceutical Technology

The two-day event included talks on subjects ranging from how to best utilise AI to how to build a stable CRO.

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FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffs

Fierce Pharma

The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. | The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. The agencys move means that compounding pharmacies will have to halt production of their knockoff versions of diabetes drug Mounjaro and obesity treatment Zepbound.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.