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FDA Grants Fast Track Designation to Clarity Pharmaceuticals’ Novel Treatment for PSMA-Positive Prostate Cancer Lesions

By Don Tracy, Associate Editor 64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says. The FDA has granted Fast Track designation to Clarity Pharmaceuticals’ 64Cu-SAR-bisPSMA, a novel imaging agent designed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions with suspected metastasis. According to the company, the agent, which was supported by promising clinical results, has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life, allowing for centralized production and flexible patient scheduling.1 “Receiving Fast Track Designation for 64Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with ...
- Source: drugdu
- 75
- August 27, 2024
SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Oxford-based SynaptixBio has been awarded a £2m BioMedical Catalyst grant from Innovate UK to support first-in-human clinical trials of its therapeutic targeting H-ABC, the most severe form of TUBB4A leukodystrophy. In November 2023, SynaptixBio received an earlier grant from Innovate UK to expand its search for rare disease therapies. The company was given a second Orphan Drug Designation from the US FDA in February this year for a therapy targeting Isolated Hypomyelination – a less severe form of TUBB4A leukodystrophy. In the UK, a rare disease is defined as a condition that affects fewer than one in 2,000 in the population and SynaptixBio is the only company licensed to commercialise a treatment for this rare, deadly and currently incurable disease. Currently, there is no cure for TUBB4A-related leukodystrophies, a group of rare neurodegenerative caused by mutations in the TUBB4A gene. The diseases result in disruption to the signals between nerve ...
- Source: drugdu
- 57
- August 27, 2024
New drug trial to investigate treatment for patients with bronchiectasis

200,000 people in the UK have what is considered a ‘hidden’ lung condition Bronchiectasis is the third most common lung condition in the UK but despite this, it is sometimes seen as a ‘hidden’ disease due to a lack of public awareness, investment and research. Now a multi-million-pound clinical trial is set to start in September to investigate whether existing drugs could be used to treat the debilitating lung disease. The disease results in persistent breathing difficulties and repeated lung infections when bronchi – tubes in the lungs – become permanently damaged and widened. There is currently no treatment or cure and, with an ageing population, numbers are increasing. Currently the disease affects one in 200 people in the UK (approximately 200,000), with an increase of 40% over the last ten years and an expected increase of a further 20% over the next decade. Researchers from EMBARC, the European Research ...
- Source: drugdu
- 59
- August 27, 2024
Eli Lilly doubles down on Oblique partnership for antibody generation

Eli Lilly is strengthening its ties with Oblique Therapeutics, as the two companies announced an expansion to their collaboration agreement to include a second “high-value target”. Building on the existing agreement from November 2023, Eli Lilly will continue to use Oblique’s AbiProt platform to discover antibodies. Specifically, Sweden-based Oblique will partner with Lilly Catalyze360-ExploR&D, an arm of the company that offers clinical development capabilities for partnered biotechs and drug developers, as per a 22 August press release. The financial terms of the expanded deal were not disclosed, and neither was the target of its application. Oblique did state that if treatments are developed successfully, the partnership will “generate milestones and royalties”. Abiprot identifies therapeutic antibodies that can be programmed to have a specific pharmacological function. Oblique states its technology can help develop effective medicines against difficult-to-drug target proteins. The biotech’s platform uses microfluidics and proteases as molecular probes and provides ...
- Source: drugdu
- 81
- August 27, 2024
AstraZeneca may pull plug on UK vaccine manufacturing plans

AstraZeneca is considering relocating its manufacturing facilities from the UK to the US, amidst potential cuts to state funding from the Labour government. UK Finance Minister Rachel Reeves has discussed plans to decrease state financial aid for the company’s £450m vaccine centre, as per the Financial Times. The pharmaceutical giant had announced plans to construct a manufacturing plant in Speke, Liverpool, as part of a £650m investment in the UK, in March 2024. Of this amount, £450m would be allocated to the facility in Speke while the other £200m would be used to develop facilities in Cambridge. Undisclosed sources briefed on discussions between the government and AstraZeneca said the Labour government may reduce the previous government’s pledge of £90m to £40m. Attracting manufacturing investment has been a key part of the life sciences strategy for the UK. The government has also pursued similar projects with other companies, similar to one ...
- Source: drugdu
- 85
- August 27, 2024
【EXPERT Q&A】Do I need to apply for Import License in Germany when exporting insulin apis to Germany?

Drugdu.com expert’s response: Regarding the question of whether an Import License is required for exporting insulin Active Pharmaceutical Ingredients (APIs) to Germany, I will address this from both international trade and pharmaceutical regulatory perspectives. Hopefully, this will provide you with valuable insights. Firstly, it is crucial to note that Germany, as a member of the European Union (EU), subjects the import and sale of pharmaceutical products, including APIs, to stringent regulatory frameworks. Typically, the import of pharmaceuticals (APIs included) must comply with the relevant EU and German laws and regulations. Whether an Import License is necessary for insulin APIs exported to Germany depends on several factors: I. EU and German Pharmaceutical Regulatory Policies: The EU’s pharmaceutical regulatory system may require prior import authorization or certification for certain pharmaceuticals or APIs. Therefore, it is essential to consult the latest EU and German pharmaceutical regulations to determine if insulin APIs are subject ...
- Source: drugdu
- 88
- August 26, 2024
Q&A with Oren Gilad, CEO of Aprea Therapeutics

By Mike Hollan Gilad discusses the ways that this method can be used to treat various cancers without putting patients through the side effects of chemotherapy. Precision medicine is gaining momentum in the life sciences industry. It’s also changing the way that researchers are approaching new treatments and therapies. Pharmaceutical Executive spoke with Oren Gilad, PhD, president and CEO of Aprea Therapeutics, about some of the ways that the company is approaching cancer treatment with this new mindset. Pharmaceutical Executive: Can you discuss the concept of synthetic lethality and how it relates to your work? Oren Gilad: Synthetic lethality is a concept where the combination of two genetic mutations leads to cell death, whereas each mutation on its own would not be lethal. Cancer cells often have specific genetic mutations that normal cells do not carry, generally because they exist because a normal mutated to become cancer. So, there’s already ...
- Source: drugdu
- 60
- August 26, 2024
GLP-1 Therapy Significantly Increases Visceral Adipose Tissue Metabolic Activity in Patients with Obesity, Obstructive Sleep Apnea

By Don Tracy, Associate Editor Findings from a study published in the Journal of the Obesity Society may significantly advance the understanding of GLP-1 analogues and their role in treating obesity.In recent years, glucagon-like peptide-1 (GLP-1) analogues, such as Ozempic, have demonstrated promising weight loss results by promoting satiety and delaying gastric emptying, thus reducing energy intake. However, a number of studies conducted in animals suggest that GLP-1 therapies may also influence energy expenditure by increasing metabolic activity in visceral adipose tissue (VAT), a more metabolically active and harmful fat depot compared to subcutaneous fat. The study’s primary objective was to determine whether VAT metabolic activation also occurs in humans and how it contributes to the weight loss effect of GLP-1 analogues.1 “This study challenges the main narrative about these newer treatments which is that they simply make you eat less, and that any action on energy burn is minimal. ...
- Source: drugdu
- 74
- August 26, 2024
【EXPERT Q&A】What is a passive medical device?

Drugdu.com expert’s response: Passive medical devices refer to those that do not rely on external energy sources (such as electricity or batteries) to perform their intended functions. These devices typically utilize physical principles like mechanics, optics, acoustics, and thermodynamics to achieve their functions, with their energy primarily derived from the human body itself or gravitational forces. I. Characteristics of Passive Medical Devices Energy Source: Passive medical devices do not depend on external power sources or other forms of energy. Instead, they operate directly using natural forces such as the human body or gravity. Function Realization: They achieve their intended medical functions through physical principles like mechanical force, pressure, optical properties, etc. Safety: Since they do not rely on external power, these devices generally do not generate electromagnetic interference or radiation during use, making them safer for the human body. II. Classification of Passive Medical Devices Passive medical devices can be ...
- Source: drugdu
- 71
- August 26, 2024
Eisai’s Leqembi deemed too costly for NHS

Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly. As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties. According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In ...
- Source: drugdu
- 70
- August 26, 2024

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