Thu.Jul 18, 2024

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Artiva prices $167M IPO, riding optimism for autoimmune cell therapy

Bio Pharma Dive

The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.

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Johnson & Johnson’s Q2 2024 net earnings drop 12.8% to $4.6bn

Pharmaceutical Technology

Johnson & Johnson has reported a 12.8% decrease in net earnings for Q2 2024, with figures falling to $4.6bn from $5.3bn in Q2 2023.

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ICMR to hold workshop on measuring oxidative stress in pre-clinical mouse models to boost pre-clinical research

AuroBlog - Aurous Healthcare Clinical Trials blog

Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.

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Boehringer cuts price of Humira biosimilar in bid to build use

Bio Pharma Dive

The German drugmaker will offer a 92% discount on a copycat version of Humira for people who pay cash for the drug through GoodRx.

Drugs 171
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Clinical Trial Shows One Drug Performs Better Than Ozempic For Weight Loss

AuroBlog - Aurous Healthcare Clinical Trials blog

Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.

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Ardelyx sues CMS over revamped kidney disease drug payment bundle

Pharmaceutical Technology

Ardelyx and two other organisations have filed a lawsuit, opposing the HHS' and CMS’ revamped kidney disease payment scheme.

Drugs 147

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Novartis reports 43% increase in net income in Q2 2024

Pharmaceutical Technology

Novartis has reported a 43% increase in net income from continuing operations reaching $3.24bn in the second quarter (Q2) of 2024.

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Pfizer's ATTR heart disease drug needs hefty discount, says ICER draft report. What about Alnylam's Amvuttra?

Fierce Pharma

Pfizer’s blockbuster drug tafamidis for the treatment of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) needs at least a 96% discount off its list price to be considered cost | Pfizer’s blockbuster tafamidis for the treatment of the rare heart disease ATTR-CM needs at least a 96% discount off its list price to be considered cost-effective under common benchmarks, a draft report by ICER has found.

Drugs 121
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Bayer eyes Nubeqa’s label expansion in prostate cancer following Phase III win

Pharmaceutical Technology

The Phase III trial evaluating Nubeqa in patients with metastatic hormone-sensitive prostate cancer met its primary endpoint.

Hormones 130
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Novartis CEO sees IRA impact ‘manageable’ in short run, maintains midterm growth goal

Fierce Pharma

As biopharma companies and the U.S. | As biopharma companies and the U.S. government near the deadline of their drug price talks under the Inflation Reduction Act, Novartis CEO said the cost cuts “might be manageable” in the short term for the firm’s first few products to be included.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA launches new rare disease innovation hub

Pharmaceutical Technology

The new hub will act as a central point of connection and engagement for the rare disease community for FDA-related concerns.

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Argenx posts J&J-rivaling Sjögren's data, massively upscales Vyvgart patient population at R&D day

Fierce Pharma

Even as argenx begins to chart a course toward a future beyond Vyvgart, the company’s flagship FcRn inhibitor still has plenty of tricks in store for the remainder of the decade. | Even as argenx begins to chart a course toward a future beyond Vyvgart, the company’s flagship FcRn inhibitor still has plenty of tricks in store for the remainder of the decade.

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MHRA approves Pierre Fabre’s vibegron to treat OAB

Pharmaceutical Technology

The UK MHRA has approved Pierre Fabre’s vibegron for the treatment of overactive bladder (OAB) syndrome in adult patients.

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CordenPharma invests €900M in expanding peptide platform to meet GLP-1 drug demand

BioPharma Reporter

CordenPharma, a US-based contract development and manufacturing organization (CDMO), will be making a â900 million investment over the next three years into expanding its peptide technology platform at its US and Europe sites.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CytoReason secures $80m investment for AI expansion

Pharmaceutical Technology

CytoReason has secured $80m in funding from a consortium of investors to expand and enhance its AI disease models.

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Top 5 CDMOs driving advanced therapies to market amid rising demand and challenges

BioPharma Reporter

Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry â a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward the market.

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Inside Canary Wharf’s infectious disease testing facility

Pharmaceutical Technology

hVIVO specialises in human challenge trials for influenza and RSV therapeutic candidates.

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Nipro's $397.8M investment brings 232 new jobs to Greenville, NC with exciting new facility

Outsourcing Pharma

Japanese medical devices company, Nipro Medical Corporation, a giant in the healthcare and medical device industry, has announced a major investment of $397.8 million to establish its first North American manufacturing center of excellence in Greenville, North Carolina.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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J&J IRA pricing offer is in, as it sticks with 2025 guidance

pharmaphorum

J&J has three of its top-selling drugs in Medicare pricing negotiations but does not expect a major hit to its finances next year

Drugs 108
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Roche’s oral GLP-1 receptor agonist shows promising early weight loss results in phase 1

BioPharma Reporter

Rocheâs recent $2.7 billion acquisition of Carmot Therapeutics is paying off, with positive results for new oral GLP-1 receptor agonist.

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PBMs will face House committee grilling next week

pharmaphorum

The House Committee on Oversight and Accountability will quiz leaders of pharmacy benefit managers (PBMs) at a hearing next week, amid scrutiny of the sector's role in rising healthcare costs in the US.The hearing – scheduled for 23rd July – is part of an ongoing investigation by the committee into PBMs' alleged anticompetitive practices launched last year and spearheaded by chairman James Comer (R-Ky).

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Amid rocky launch, Boehringer Ingelheim links up with GoodRx to offer its Humira biosimilar at a steep discount

Fierce Pharma

In the year since the Humira biosimilar floodgates opened, AbbVie’s star immunology player has proven tough to drown out. | Through GoodRx, the German drugmaker's Humira copycat is priced 92% cheaper than AbbVie's branded Humira, which still holds 82% of the market despite the biosimilar competition.

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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

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Study reveals new AI tool predicts recurrence of prostate cancer by a decade

Pharma Times

The most commonly diagnosed cancer in men in the UK leads to over 12,000 annual deaths

Research 120
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Aveo spins a silver lining in failed trial of kidney cancer drug Fotivda

Fierce Pharma

The addition of Bristol Myers Squibb’s Opdivo to a low dose of Aveo Oncology’s Fotivda failed to extend the time before tumor progression or death in kidney cancer patients who had tried an im | The addition of Bristol Myers Squibb’s Opdivo to a low dose of Aveo Oncology’s Fotivda failed to extend the time before tumor progression or death compared with Fotivda alone in kidney cancer patients who had tried an immune checkpoint inhibitor.

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Boehringer backs Brainomix AI software for lung fibrosis

pharmaphorum

Boehringer Ingelheim has joined forces with digital health firm Brainomix on a project to improve the care of people with fibrosing lung diseases

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How to Transition to a New CDMO Smoothly

Drug Patent Watch

Transitioning to a new Contract Development and Manufacturing Organization (CDMO) can be a complex and challenging process.

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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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George Church Startup Nets $60M to Take Non-Standard Amino Acids to the Clinic

BioSpace

GRO Biosciences will use the Series B funds to launch a Phase I trial for ProGly-Uricase, its investigational therapy for gout.

Trials 96
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Cystic fibrosis drug improves outcomes in severe COVID-19 pneumonia

Pharma Times

Genentech’s Pulmozyme could also treat other respiratory infections and conditions

Drugs 109
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Discover how Marwan Fathallah is transforming DIA and hoping to revolutionize global healthcare

Outsourcing Pharma

At the DIA 60th annual conference in San Diego, senior editor Liza Laws from Outsourcing Pharma had the opportunity to sit down with Marwan Fathallah, President and CEO of DIA.

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Roche shows durability of eye disease treatments Vabysmo, Susvimo

Fierce Pharma

After storming the market with its longer-acting macular degeneration shot Vabysmo, Roche is laying the groundwork to expand the reach of its other eye disease innovation—refillable implant Susvimo | After storming the market with its longer-acting macular degeneration shot Vabysmo, Roche is laying the groundwork to expand the reach of its other eye disease innovation—refillable implant Susvimo.

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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.