Thu.Jun 13, 2024

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Versant debuts biotech working on ‘anger management for the immune system’

Bio Pharma Dive

Investor enthusiasm for precision immunology medicines is providing a tailwind for Santa Ana Therapeutics, a new startup backed by Versant, GV and a16z, among others.

Medicine 190
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FDA approves AstraZeneca’s Farxiga for paediatric T2D patients

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.

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Pfizer setback brings questions for Duchenne gene therapy ahead of Sarepta decision

Bio Pharma Dive

The failure of another trial adds to uncertainty around the benefits of the gene-based treatments, though industry analysts still expect Sarepta’s Elevidys’ to be unaffected.

Gene 244
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June 13, 2024: Burgess to Present Results of LAMP Trial, Precursor of NIH Collaboratory’s RAMP Trial

Rethinking Clinical Trials

Dr. Diana Burgess Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems Research Cyberseminars series. The Learning to Apply Mindfulness to Pain (LAMP) trial is a multisite pragmatic clinical trial that compared 2 approaches for delivering mindfulness-based interventions via telehealth for veterans with chronic pain.

Trials 162
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Moderna says next-gen COVID shot effective in study

Bio Pharma Dive

Trial data suggest the shot — an important component of an upcoming combination inoculation — has proven at least as effective, and in some cases superior, to the company’s initial COVID vaccine.

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NPX-267 by NextPoint Therapeutics for Transitional Cell Carcinoma (Urothelial Cell Carcinoma): Likelihood of Approval

Pharmaceutical Technology

NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Transitional Cell Carcinoma (Urothelial Cell Carcinoma).

More Trending

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Barinthus Bio slashes headcount by 25% and refocuses pipeline

Pharmaceutical Technology

Two Hepatitis B and coeliac disease candidates will be the priority for the company whilst a prostate cancer asset appears to be sidelined.

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GLP-1 Global Obesity Market to Reach $111B by 2033, Despite Headwinds: GlobalData

BioSpace

While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market.

Marketing 128
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NPX-267 by NextPoint Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval

Pharmaceutical Technology

NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Triple-Negative Breast Cancer (TNBC).

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BMS’ Augtyro Wins FDA Accelerated Approval for NTRK-Positive Solid Tumors

BioSpace

Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.

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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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PF-07960613 by Pfizer for Respiratory Syncytial Virus (RSV) Infections: Likelihood of Approval

Pharmaceutical Technology

PF-07960613 is under clinical development by Pfizer and currently in Phase II for Respiratory Syncytial Virus (RSV) Infections.

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J.P. Morgan Raises Over $500M for First Biotech Venture Capital Fund

BioSpace

J.P. Morgan’s life sciences venture capital arm on Thursday announced it closed its first biotech fund, targeting companies in cardiometabolic disease, immunology, oncology and genetic medicine.

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NHS and ABPI announce new guidelines ahead of UK elections

Pharmaceutical Technology

The new guidelines outline ways to develop NHS-industry partnerships and follow the ABPI’s manifesto.

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The B2C prescription: Marketing lessons for B2B pharma companies

pharmaphorum

Learn valuable marketing lessons for B2B pharma companies by examining successful strategies used in the B2C prescription market, including over-the-counter (OTC) products and interactions with healthcare professionals (HCPs).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NPX-267 by NextPoint Therapeutics for Pancreatic Ductal Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Pancreatic Ductal Adenocarcinoma.

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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

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GSK and Ochre Bio link to explore liver disease drivers

Pharmaceutical Technology

GSK has entered into a multi-year data licence agreement with Ochre Bio, aiming to advance the understanding of liver disease.

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Launch Excellence: Moments of Truth

pharmaphorum

Explore the key moments of truth in launch excellence for MSLs and commercial teams in this informative white paper. Gain valuable insights and strategies for successful launches.

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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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Alzheon secures $100m to advance Alzheimer’s disease treatment

Pharmaceutical Technology

Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).

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Telix Abandons IPO Plans at Last Minute, Cites ‘Current Market Conditions’

BioSpace

Telix abruptly pulled the plug on its initial public offering plans to begin trading Friday on the Nasdaq, saying the company “did not feel that the proposed discounts were aligned with its duty to its existing shareholders.

Marketing 113
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NHS boss praises managers and leaders as Tories seek to scrap £1bn funding

Pharmaceutical Technology

NHS England chief executive Amanda Pritchard laid out a three-point plan to help support the future of the health service.

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SCOTUS Upholds Access to Abortion Pill, Pharma Industry Applauds Court’s Ruling

BioSpace

The U.S. Supreme Court on Thursday upheld access to the abortion pill mifepristone, unanimously rejecting a challenge by a group of anti-abortion doctors seeking to undo the FDA’s approval of the drug.

Doctors 109
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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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NPX-267 by NextPoint Therapeutics for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Non-Small Cell Lung Cancer.

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Flagship, ProFound set off on obesity drug hunt for Pfizer

pharmaphorum

Pfizer has had some setbacks in its efforts to develop drugs for the lucrative obesity market, but could see its pipeline swell thanks to its $7 billion partnership with venture capital firm Flagship Pioneering. Flagship has just announced that it will work with biotech startup ProFound Therapeutics to find first-in-class protein therapeutics with potential in obesity, confirming this is the first programme in the alliance with Pfizer signed last July.

Drugs 105
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NPX-267 by NextPoint Therapeutics for Renal Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Renal Cell Carcinoma.

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NIH Invests $30 Million in a Community-Based Primary Care Network to Promote Health Equity

XTalks

As reported by Statista, in 2021, the US allocated 17.8 percent of its gross domestic product (GDP) to healthcare, amounting to a whopping 4.4 trillion US dollars in 2022. The burden of chronic diseases and obesity is particularly severe in the US; the 2020 Commonwealth Fund International Health Policy Survey revealed that 30.4 percent of adults reported having two or more chronic conditions such as heart disease, diabetes and depression.

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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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NPX-267 by NextPoint Therapeutics for Endometrial Cancer: Likelihood of Approval

Pharmaceutical Technology

NPX-267 is under clinical development by NextPoint Therapeutics and currently in Phase I for Endometrial Cancer.

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With Donanemab on the Cusp of Approval, Proper Alzheimer’s Diagnosis Is Urgent

BioSpace

Accurately diagnosing Alzheimer’s disease pathologies is becoming increasingly important, but the U.S. is facing imaging resource constraints.

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Flagship Pioneering and ProFound link for obesity therapies

Pharmaceutical Technology

Flagship Pioneering and ProFound Therapeutics partnered to detect new therapeutics for the treatment of obesity.

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EU Says India’s Alchem Is Part of International Drug Price-Fixing Cartel

BioSpace

The European Commission has tagged India-based pharma Alchem as being part of a global cartel that coordinates the pricing of a pharmaceutical ingredient in the antispasmodic drug Buscopan.

Drugs 101
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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.