Wed.Feb 28, 2024

article thumbnail

After steep cost cuts, Novavax's fourth-quarter performance falls short of expectations

Fierce Pharma

As Novavax emerges from its “transition year” in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024. | As Novavax emerges from its “transition year” in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024.

238
238
article thumbnail

What Are the Biggest Misconceptions in the Mental Health Space? One Exec Weighs In

MedCity News

There are several misconceptions when it comes to mental healthcare, including that AI means fully automated therapy chatbots and that mental health and physical health are separated, according to Dr. Mimi Winsberg, chief medical officer of Brightside Health.

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

Seeking blockbuster status, UCB eyes four new indications for psoriasis med Bimzelx in 2024

Fierce Pharma

After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels. | After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. The company is eying four new indications and potential peak sales of 4 billion euros.

FDA 221
article thumbnail

Beacon Therapeutics unveils promising interim results for gene therapy AGTC-501

Pharmaceutical Technology

AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space

122
122
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

After Idorsia deal, Viatris' dealmaking appetite remains strong, CEO says

Fierce Pharma

On the back of its $350 million deal for two late-stage Idorsia assets, Viatris will continue to be “opportunistic” when it comes to making future business development grabs—especially on the comme | On the back of its $350 million deal for two late-stage Idorsia assets, Viatris will continue to be “opportunistic” when it comes to making future business development grabs—especially on the commercial side—executives said Wednesday.

212
212
article thumbnail

Roots Start to Show for Hair Loss Startup Pelage With a Peek at First Clinical Data

MedCity News

Regenerative medicine startup Pelage Pharmaceuticals has clinical data showing its small molecule activated hair follicle stem cells. GV led a Series A round that funded the UCLA spinout’s Phase 1 clinical trial and will also support Phase 2 testing this year.

More Trending

article thumbnail

Rare Disease is Anything But Rare – A Parent’s Perceptive on Navigating Uncertainty & the Promise of mRNA Medicine

MedCity News

This Rare Disease Day is an opportunity to raise awareness of the challenges those living with a rare disease face, and why there’s reason to hope, thanks to advances in science that could potentially change the lives of millions of patients.

article thumbnail

EuroAPI appoints new CEO and lays out restructuring plan as manufacturer's losses mount

Fierce Pharma

With a new CEO tapped to drive EuroAPI’s turnaround, the Sanofi spinoff is proposing drastic steps to get its business on track, including potential layoffs and site closures. | EuroAPI's four-year restructuring campaign will include streamlining the company’s active pharmaceutical ingredients portfolio, becoming a more “focused” contract development and manufacturing organization, developing a “rationalized” industrial footprint and transforming into a “leaner organization.

article thumbnail

MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Adam Petrich, Chief Medical Officer at QuantHealth

MedCity News

In this month’s episode, Senior Reporter Katie Adams discussed some executive hires, promotions and departures that recently occurred in the healthcare world, as well as layoffs affecting the industry. We also hear from Adam Petrich, who recently became QuantHealth’s first chief medical officer.

Medical 95
article thumbnail

AbbVie inks $713m deal for OSE chronic inflammation drug

pharmaphorum

AbbVie has made another bolt-on deal in the immunology and inflammation category, paying $48 million upfront for rights to an antibody in preclinical development at OSE Immunotherapeutics. There’s another $665 million in potential milestones and a royalty tied to the deal, which focuses on OSE-230, billed as a potentially first-in-class activator of ChemR23, a G-protein coupled receptor (GPCR) found on some white blood cells.

90
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

Lower Health Care Costs, Help Inmates. Why Aren’t There PrEP Programs in Prison?

MedCity News

Prisons should offer abundant opportunities for HIV screening and comprehensive pre-exposure prophylaxis (PrEP) adherence programs to benefit incarcerated individuals and carceral systems as a whole.

90
article thumbnail

Pelage secures funds to develop regenerative medicine for hair loss

Pharmaceutical Technology

Pelage Pharmaceuticals has secured $16.75m in a Series A financing round to further the development of PP405 for hair loss.

Medicine 104
article thumbnail

Don’t Miss the Best Boutique Healthcare Investment Conference — Register for MedCity INVEST Today!

MedCity News

MedCity INVEST 2024, scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, is the ideal event to discuss healthcare funding with investors looking for investment opportunities.

article thumbnail

Amneal signs agreement with Zambon for Parkinson’s disease therapy

Pharmaceutical Technology

Amneal has signed an agreement with Zambon Biotech for IPX203 for the treatment of Parkinson's disease (PD) in certain regions.

98
article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

article thumbnail

PHTI to review digital hypertension, mental health tools

pharmaphorum

Peterson Health Technology Institute will review the clinical effectiveness and economic impact of digital health technologies (DHTs) for hypertension and mental health.

83
article thumbnail

EMA and FDA green-light MoonLake to advance IL-17 inhibitor

Pharmaceutical Technology

The Phase III VELA programme will compare the IL-17 inhibitor sonelokimab to a placebo, enrolling 800 patients over 52 weeks.

FDA 100
article thumbnail

Implications of AI regulation for data integrity

European Pharmaceutical Review

A study published in the Asian Journal of Advanced Research and Reports , has reported “a strong positive correlation between higher levels of regulatory compliance and perceived effectiveness in artificial intelligence (AI) implementation, as well as between AI ethics awareness and data integrity assurance.” The research highlighted the importance of regulatory frameworks and professional training in shaping AI development, specifically “dynamic, adaptable, and inclusive regulatory frameworks t

Ethics 78
article thumbnail

Beyond approval: Patients pursue alternate paths to get rare disease treatments

Pharmaceutical Technology

As post-approval boundaries disproportionately affect rare disease patients, communities are rallying behind alternative options.

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

article thumbnail

Viatris splashes out $350m on pair of Idorsia therapies

pharmaphorum

Viatris licenses two late-stage drugs from Idorsia for heart attack and lupus, both claimed to have blockbuster sales potential, for $350m upfront.

Sales 86
article thumbnail

The importance of high-quality raw materials in the development of Regenerative Medicine

Pharmaceutical Technology

Regulatory standards concerning raw material selection are particularly stringent when it comes to Regenerative Medicines.

article thumbnail

ICR study reveals new targeted immunotherapy to prevent spread of breast cancer

PharmaTimes

Breast cancer is responsible for around 47,000 new cases in England every year

115
115
article thumbnail

Janux plans $200m offer on back of prostate cancer readout

pharmaphorum

Buoyed by data from a trial of its T-cell engager (TCE) therapy in prostate cancer that almost tripled its share price, Janux Therapeutics has moved quickly to file a stock offering that could add around $200 million to its cash position. The San Diego biotech is offering $175 million in a public offering that could rise to $201.5 million if underwriters take up an option, less discounts and commissions.

75
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

article thumbnail

MedCity Pivot Podcast: A Conversation with Lumen CEO Daniel Tal Mor

MedCity News

In this episode, the CEO of Lumen talks about the sleek consumer device and why he is at a b-to-b healthcare conference.

article thumbnail

Survey Reveals Americans’ Frustrations With the Healthcare System

Pharmaceutical Commerce

An MDVIP study reports that 61% of people feel hassled by the current structure.

article thumbnail

Unleashing the power of computational tools in rare disease

Clarivate

In the vast landscape of pharmaceutical innovation, few therapy areas present challenges and opportunities as compelling as those faced in rare disease. These conditions, affecting small patient populations and characterized by diverse clinical manifestations, demand innovative approaches and cutting-edge technologies to drive research and commercialization forward.

article thumbnail

Reusable ECGI vest successfully detects early signs of inherited hypertrophic cardiomyopathy

PharmaTimes

The inherited fatal heart muscle condition affects one in every 500 adults in the UK

84
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

article thumbnail

Finding the Ideal Set of Oncology Employer Benefits

Pharmaceutical Commerce

A Carrum Health/PWC report surveys benefit managers spanning various self-insured employers in an effort to determine ways to improve the cancer treatment experience, especially from a cost perspective.

article thumbnail

Demystifying the 5G standard essential patent landscape with manual SEP analysis: Phase 4

Clarivate

In a new report [1] , Clarivate patent experts provides an update on core patents to 5G standards. In the report Demystifying the 5G standard essential patent landscape with manual SEP (Phase 3) published in February 2023, we presented findings from our extensive review of the granted patent families declared essential to 5G as of December 31, 2021.

52
article thumbnail

Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers

PharmaTech

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Safety 52
article thumbnail

Cencora VP of Reimbursement & Policy Insights Discusses Implications of the Inflation Reduction Act

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Corey Ford, VP, Reimbursement, Policy Insights, Cencora, provides a look at his recent webinar focused on the implications of the Inflation Reduction Act.

Pharma 52
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.