Wed.Feb 07, 2024

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Venture firm Scion Life Sciences launches with $310M to back new biotechs

Bio Pharma Dive

The new firm intends to carefully select its startups and fund them for the long haul. “We're not a company formation factory,” said Aaron Kantoff, the firm’s co-founder.

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Bipolar Disorder Linked to a Higher Risk of Early Death Than Smoking

AuroBlog - Aurous Healthcare Clinical Trials blog

People with bipolar disorder are four to six times more likely to die prematurely than those without the condition, according to a study that compared data on thousands of people with and without the disorder.

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Kyverna IPO adds to biotech momentum with $319M fundraise

Bio Pharma Dive

The company, a leading developer of cell therapies for autoimmune diseases, is the fifth drug startup to go public in 2024. All of them raised at least $100 million.

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AstraZeneca invests $300m to build new facility in US

Pharmaceutical Technology

AstraZeneca is investing $300m in a facility in Rockville, US - a significant step in launching its cell therapy platforms in the country.

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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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February 7, 2024: Pragmatic Recruitment of Underrepresented Groups, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.” The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern. Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System.

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Gilead Sciences posts $5.61bn net income in FY 2023

Pharmaceutical Technology

Gilead Sciences has announced a 22.9% increase in net income of $5.61bn for FY23 as against $4.56bn in FY22.

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BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.

Gene 188
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BridgeBio sells partial rights to dwarfism drug for $100M

Bio Pharma Dive

The deal hands Kyowa Kirin rights in Japan to the drug, which is emerging as a potential rival to BioMarin’s marketed medicine Voxzogo.

Drugs 152
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Elotuzumab by AbbVie for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF): Likelihood of Approval

Pharmaceutical Technology

Elotuzumab is under clinical development by AbbVie and currently in Phase II for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).

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Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do? (Susan C. Winckler, RPh, Esq)

Rethinking Clinical Trials

            Speaker Susan C. Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated

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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.

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Avadomide hydrochloride by Bristol-Myers Squibb for Follicular Lymphoma: Likelihood of Approval

Pharmaceutical Technology

Avadomide hydrochloride is under clinical development by Bristol-Myers Squibb and currently in Phase I for Follicular Lymphoma.

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Obesity drug mania takes over Amgen’s earnings call

Bio Pharma Dive

Analysts pressed company executives Tuesday on the potential of its GLP-1 drug for weight loss, early-stage results for which were published this week.

Drugs 177
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Enfortumab vedotin by Astellas Pharma for Esophageal Squamous Cell Carcinoma (ESCC): Likelihood of Approval

Pharmaceutical Technology

Enfortumab vedotin is under clinical development by Astellas Pharma and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC).

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AstraZeneca to invest $300M in US cell therapy plant

Bio Pharma Dive

The UK drugmaker is adding a facility in Rockville, Maryland, after a spate of dealmaking in the therapeutic field.

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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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(Sacubitril + valsartan) by Novartis for Hypertrophic Cardiomyopathy: Likelihood of Approval

Pharmaceutical Technology

(Sacubitril + valsartan) is under clinical development by Novartis and currently in Phase II for Hypertrophic Cardiomyopathy.

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

FDA Law Blog

By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr

Sales 116
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Irinotecan hydrochloride by Ipsen for Neuroendocrine Carcinoma: Likelihood of Approval

Pharmaceutical Technology

Irinotecan hydrochloride is under clinical development by Ipsen and currently in Phase II for Neuroendocrine Carcinoma.

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From a fascination with viruses to a desire to make a lasting impact, Immunic's Hella Kohlof shares her journey

BioPharma Reporter

Wedneday is Women in Science day and we have a fantastic interview with Hella who is co-founder and chief scientific officer of Immunic Therapeutics.

Research 118
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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.

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FDA clear Veru’s IND for GLP-1 RA-associated muscle loss drug

Pharmaceutical Technology

Veru’s Ostarine has previously been investigated in five clinical studies in patients with muscle wastage caused by advanced cancer.

Drugs 147
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This week in clinical trials: 15th-19th January 2024

pharmaphorum

Stay updated on the latest clinical trials happening from January 15th to January 19th, 2024. Explore trials by ExeVir, NurixTx, Synendos Therapeutics, and Oxford BioTx.

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Ligelizumab by Novartis for Food Allergy: Likelihood of Approval

Pharmaceutical Technology

Ligelizumab is under clinical development by Novartis and currently in Phase III for Food Allergy.

Allergies 187
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Jazz buys KRAS inhibitors from Redx in $880m deal

pharmaphorum

Jazz Pharmaceuticals has agreed another pipeline-building deal, this time paying $10 million upfront for rights to a KRAS inhibitor programme from UK biotech Redx Pharma, continuing a move into targeted cancer therapies. Under the terms of the deal, Jazz will acquire Redx’s KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market.

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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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Elotuzumab by AbbVie for Myelofibrosis: Likelihood of Approval

Pharmaceutical Technology

Elotuzumab is under clinical development by AbbVie and currently in Phase II for Myelofibrosis.

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Brighter times ahead for biotech in 2024?

pharmaphorum

As the pandemic recedes and the global economy stabilises, are there promising signs for the biotech industry's financial outlook in 2024? Learn more about the potential for recovery, reducing bankruptcies, and attracting investors.

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Abiraterone acetate by Tavanta Therapeutics for Hormone-Sensitive Prostate Cancer: Likelihood of Approval

Pharmaceutical Technology

Abiraterone acetate is under clinical development by Tavanta Therapeutics and currently in Phase III for Hormone-Sensitive Prostate Cancer.

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JP Morgan 2024 – Simon Arkell

pharmaphorum

In this interview, Simon Arkell, co-founder and CEO of Ryght, discusses his vision whilst at JP Morgan 2024 and how generative AI is transforming the industry.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Immunome wins Ayala’s Phase III desmoid tumour candidate for $50m

Pharmaceutical Technology

The acquisition, which also includes Phase II asset AL101, closes gap to SpringWorks’ FDA-approved Ogsiveo.

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Brainomix’s AI-enabled stroke software endorsed by NICE

Pharma Times

The HTA reported that Brainomix 360 improved access to treatment for stroke patients

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Five ways disconnected consent is impacting patient experiences

Pharmaceutical Technology

When consent management processes are disconnected or poorly managed, it can have a detrimental impact on patient experiences.

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GSK backs up its Blenrep rehab bid with survival data

pharmaphorum

GSK has revealed the data it hopes will allow a return to the US market for Blenrep, which was the first BCMA-targeting drug to launch there but was withdrawn from sale after it failed a confirmatory trial.

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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.