Wed.Feb 28, 2024

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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.

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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.

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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.

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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

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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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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.

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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.

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Making ATMPs a reality for rare disease patients

European Pharmaceutical Review

The implementation of the EU’s Health Technology Assessment Regulation (HTAR) 1 will play a key role in shaping the patient access pathway for ATMPs such as cell and gene therapies. This is a great opportunity for healthcare systems in Europe to benefit from the latest therapeutic innovations which can offer life-changing outcomes to those suffering from debilitating conditions.

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Apellis cites current challenges with Syfovre launch but bright prospects in the long term

Fierce Pharma

The first 12 months on the market for Apellis’ geographic atrophy (GA) drug Syfovre have been a roller-coaster ride. And there’s still more loops to negotiate. | The first 12 months on the market for Apellis’ geographic atrophy (GA) drug Syfovre have been a rollercoaster ride. And there are still more loops to negotiate. On Tuesday, when Apellis presented its quarterly earnings, its report raised more questions about Syfovre than it answered.

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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

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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.

Medicine 105
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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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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.

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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.

Medicine 103
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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 102
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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 100
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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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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.

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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.

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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.

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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.

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

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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.

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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.

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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

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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.

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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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Survey Reveals Americans’ Frustrations With the Healthcare System

Pharmaceutical Commerce

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

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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.

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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.

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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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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

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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.

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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.

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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
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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