Tue.Jun 06, 2023

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Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

Genetics 279
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FDA sets advisory meeting date for Brainstorm’s ALS cell therapy

Bio Pharma Dive

Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

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Oragenics secures CQDM funding for Covid-19 vaccine antigen development

Pharmaceutical Technology

Oragenics has secured funding from the Canadian bioresearch consortium CQDM to develop a variant-agnostic protein antigen for use in its Covid-19 intranasal vaccine. SynergiQC, the Quebec-based funding programme created by CQDM, has awarded the funding. The project is a partnership with Inspirevax and the National Research Council of Canada (NRC). In March 2023, Oragenics and Inspirevax entered an exclusive global licence deal to develop the former’s lead intranasal Covid-19 vaccine candidate, N

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Using twin viruses, startup AAVantgarde aims to extend gene therapy’s reach

Bio Pharma Dive

The biotech has raised about $65 million to test two ways to deliver larger genes into the body, each of which could help gene therapy treat more diseases.

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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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This Pill Can Halve The Risk of Death After Lung Cancer, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

A pill has been shown to halve the risk of death from a certain type of lung cancer when taken daily after surgery to remove the tumor, according to clinical trial results presented on Sunday.

Scientist 169
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Closing ASCO: AstraZeneca’s ‘very special’ meeting, more CAR-T survival data and Pfizer’s PARP play

Bio Pharma Dive

Dramatically positive trial data for AstraZeneca’s Tagrisso capped an important conference for the British drugmaker, while Gilead built a stronger case for its cell therapy Yescarta.

Trials 235

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FDA staff appear supportive of RSV drug from AstraZeneca, Sanofi

Bio Pharma Dive

Agency scientists raised no major red flags in their review of the antibody medicine in documents posted ahead of a Thursday meeting of FDA advisers.

Antibody 183
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June 6, 2023: INSPIRE Demonstration Project Principal Investigators Share Update at Annual Steering Committee Meeting

Rethinking Clinical Trials

In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in Bethesda, Maryland, Richard Platt, MD, MS (co-principal investigator) and Shruti Gohil, MD, MPH (lead investigator) of the INSPIRE Demonstration Project , shared the status of the trials, discussed recent lessons learned, described the impact they hope their trials will have on the future of healthcare, and reflected on the impact the NIH Collaboratory has had on their trials thus far.

Trials 130
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Merck sues to block Medicare negotiation of drug prices

Bio Pharma Dive

The drugmaker’s lawsuit claims the new pricing powers granted by the Inflation Reduction Act are unconstitutional and “tantamount to extortion.

Drugs 152
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USPTO issues notice of allowance for Enveric’s EVM301 series

Pharmaceutical Technology

The United States Patent and Trademark Office (USPTO) has issued a notice of allowance for Enveric Biosciences’ patent application for the EVM301 series of drug candidates to treat mental health disorders. The patent, which is expected to be issued shortly, will contain composition of matter claims for a family of tryptamine-based drug candidates. This family of new small molecules has been designed to promote neuroplasticity without inducing hallucinations.

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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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Need to amend Schedule P of D&C Act to include stringent norms on disposal of unused & expired medicines

AuroBlog - Aurous Healthcare Clinical Trials blog

There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment. The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act.

Medicine 134
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Lotus, NRx and Alvogen team up for S-TRBD therapy NRX-101

Pharmaceutical Technology

Lotus Pharmaceuticals, NRx Pharmaceuticals and Alvogen have entered a global collaboration deal to develop and commercialise NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD). Lotus will purchase global rights for NRX-101 and handle the commercialisation activities of the product in markets outside the US. The company will collaborate with Alvogen to commercialise NRX-101 in the US through the Almatica label, the CNS-focused division of Alvogen.

Sales 130
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Antibiotic maker Paratek, low on cash, agrees to a buyout

Bio Pharma Dive

Gurnet Point Capital and Novo Holdings aim to take Paratek private in a deal that highlights the challenges small biotechs face selling new antibiotics.

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FDA approves INJECTAFER for iron deficiency in heart failure adult patients

Pharmaceutical Technology

American Regent and Daiichi Sankyo have announced that the INJECTAFER (ferric carboxymaltose injection) has received approval from the US Food and Drug Administration (FDA) to treat iron deficiency in adult patients with heart failure. The therapy is indicated to improve exercise capacity in heart failure patients, who are categorised as New York Heart Association class II/III based on the severity of their symptoms.

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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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Merck challenges HHS on Medicare drug price negotiations, alleging violations of the Constitution

Fierce Pharma

The pharma industry has voiced loud complaints about the Biden administration's Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-se | The pharma industry has voiced loud complaints about the Biden administration's Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-selling pharmaceuticals.

Drugs 105
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Bezuclastinib by Cogent Biosciences for Systemic Mastocytosis: Likelihood of Approval

Pharmaceutical Technology

Bezuclastinibis under clinical development by Cogent Biosciences and currently in Phase II for Systemic Mastocytosis.

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Eisai hit with ransomware attack, launches investigation into possible data leaks

Fierce Pharma

Eisai is the latest drugmaker to be hit with a ransomware attack. | Eisai was the victim of a ransomware attack late Saturday night and is now working on response efforts, including the creation of a company-wide task force.

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PRT-811 by Prelude Therapeutics for CNS Lymphoma: Likelihood of Approval

Pharmaceutical Technology

PRT-811is under clinical development by Prelude Therapeutics and currently in Phase I for CNS Lymphoma.

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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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Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019

ProRelix Research

Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases. However, […] The post Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019 appeared first on ProRelix Research.

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Risk adjusted net present value: What is the current valuation of Exelixis’s XB-002?

Pharmaceutical Technology

XB-002 is a monoclonal antibody conjugated commercialized by Exelixis, with a leading Phase I program in Esophageal Squamous Cell Carcinoma (ESCC). According to Globaldata, it is involved in 1 clinical trial, which is ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of XB-002’s valuation in its risk-adjusted NPV model (rNPV).

Antibody 100
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Water Recipes: The Rise and Controversy of the WaterTok Trend

XTalks

The digital age has brought us an array of novel concepts, trends and terminologies, adding a fresh zest to our everyday lexicon. One such recent phenomenon making waves on social media is water recipes. This term might initially baffle those unacquainted with the trend, but it’s relatively simple and straightforward. Water recipes refer to a variety of methods to enhance plain water by adding flavorings, typically sugar-free syrups, powdered flavorings or a combination of the two.

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Risk adjusted net present value: What is the current valuation of Pfizer’s PF-06835375?

Pharmaceutical Technology

PF-06835375 is a biologic commercialized by Pfizer, with a leading Phase II program in Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura). According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of PF-06835375’s valuation in its risk-adjusted NPV model (rNPV).

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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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Novo Holdings, Gurnet Point team up to buy antibiotics maker Paratek for $462M

Fierce Pharma

Novo Holdings and Gurnet Point have added antibiotics maker Paratek Pharma to their fold in a biopharma M&A deal worth approximately $462 million. | Paratek's key selling point is its antibiotic, Nuzyra, which was expected to garner $500 million in peak sales at the time of its 2018 approval.

Sales 96
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Risk adjusted net present value: What is the current valuation of Moderna’s MRNA-0184?

Pharmaceutical Technology

MRNA-0184 is an oligonucleotide commercialized by Moderna, with a leading Phase I program in Congestive Heart Failure (Heart Failure). According to Globaldata, it is involved in 1 clinical trial, which is ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of MRNA-0184’s valuation in its risk-adjusted NPV model (rNPV).

RNA 100
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Posluma Is a Novel PET Imaging Agent for Prostate Cancer Detection

XTalks

Prostate cancer stands as the second leading cause of cancer death among American men. Its early detection enhances the likelihood of survival, and survival is greatly influenced by the type and localization of the cancer. As a result, there is a constant demand for highly specific molecular imaging technologies. Recently, Blue Earth Diagnostics announced that the US Food and Drug Administration (FDA) has granted approval to its novel, high-affinity radiohybrid prostate-specific membrane antigen

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Risk adjusted net present value: What is the current valuation of Pharma Mar’s Ecubectedin?

Pharmaceutical Technology

Ecubectedin is a small molecule commercialized by Pharma Mar, with a leading Phase II program in Hormone Sensitive Breast Cancer. According to Globaldata, it is involved in 5 clinical trials, which are ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of Ecubectedin’s valuation in its risk-adjusted NPV model (rNPV).

Hormones 100
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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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Biocomposites embraces NanoBone technology following acquisition of Artoss GmbH

Pharma Times

The structure of NanoBone triggers bone-forming systems while also aiding rapid bone healing - News - PharmaTimes

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Who’s posting what? Virtual Care related social media posts increased by 21% in the pharma industry in Q1 2023

Pharmaceutical Technology

The global pharma industry experienced a 21% rise in social media posts on virtual care in Q1 2023 compared with the previous quarter, with the highest share accounted for Bicycle Health, according to GlobalData’s analysis of social media posts. GlobalData’s Telehealth Market Size by Segments, Share, Trends, and Forecast, 2022-2030 report provides key insights into business strategies, trends driving the telehealth market and granular data on market segments forecast up to 2030.

Marketing 100
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New COVID-19 vaccine successfully tested

Pharma Times

Rocketvax and Basel University therapy uses a modified coronavirus that activates an immune response - News - PharmaTimes

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Who’s posting what? Regenerative Medicine related social media posts increased by 11% in the pharma industry in Q1 2023

Pharmaceutical Technology

The global pharma industry experienced an 11% rise in social media posts on regenerative medicine in Q1 2023 compared with the previous quarter, with the highest share accounted for Pfizer, according to GlobalData’s analysis of social media posts. GlobalData’s Regenerative Medicine in Medical thematic intelligence report provides an overview of the current landscape, including healthcare, technology, regulatory, macroeconomic trends, and key players.

Medicine 100
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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.