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Jaguar Gene Therapy investors carve out manufacturing unit as a separate company

Three years after bringing Jaguar Gene Therapy out of stealth, Deerfield Management is leading the funding of a manufacturing spinout from the Illinois company. Deerfield, with the help of ARCH Venture Partners and Nolan Capital, is backing a new company—Advanced Medicine Partners—which was formerly responsible for Jaguar’s chemistry, manufacturing and controls (CMC). The new firm seeks to provide best-in-class development of advanced medicines, including gene and cell therapies, addressing quality and scaling issues that have hindered new treatments. The management and technical teams have directed the CMC work of several approved products, including three gene therapies. In a release, CEO Andrew Knudten touted the experience of Advanced Medicine Partners’ genetic medicines team, which has manufactured roughly 350 non-GMP batches and supplied more than 20 preclinical studies. “With so many biotechnology companies being slowed or halted due to manufacturing challenges including product quality and scalability, we have the experienced people and ...
- Source: drugdu
- 131
- January 19, 2024
J&J, AZ/Daiichi Sankyo cancer therapies lead Clarivate’s annual rundown of notable new meds

Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
- Source: drugdu
- 164
- January 19, 2024
US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement

After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark Office (U.S. PTO) has handed Daiichi the latest win in the saga. For years, the companies have clashed over Seagen’s so-called “‘039 patent,” which covers certain peptides conjugated to an antibody through various linkers. After a 2008 antibody-drug conjugate (ADC) partnership between the drugmakers ended in 2015, Daiichi Sankyo entered into a lucrative agreement with AstraZeneca to work on what became the cancer blockbuster Enhertu. Seagen staked a claim on the AZ contract in a 2020 lawsuit, arguing that the technology used for the med was created under its previous Daiichi ADC partnership. In 2022, a Texas jury found that Daiichi Sankyo stepped on Seagen’s patent willfully, awarding the latter company $41.8 million in royalties. The now Pfizer-owned company took its case a step further by asking for royalties from future U.S. ...
- Source: drugdu
- 156
- January 19, 2024
Blood Test to Track Gene Expression in the Brain Could Help Prevent Neurological Diseases

Encased within a complex network of specialized blood vessels, the brain remains the body’s most protected organ. This intricate structure, while protective against external threats, poses significant challenges for researchers seeking to understand gene expression dynamics and their link to diseases. Addressing this challenge, scientists have now introduced a noninvasive method to track gene expression in the brain, potentially transforming research in brain development, cognitive function, and neurological disorders. The team of scientists at Rice University (Houston, TX, USA) has developed a groundbreaking class of molecules named released markers of activity (RMAs). These RMAs offer a noninvasive solution to measure gene expression in the brain via a simple blood test. Traditionally, assessing gene expression in the brain has been limited to post-mortem analysis or less sensitive and specific modern neuroimaging techniques. The RMA platform, however, introduces a synthetic gene expression reporter into the brain, which synthesizes a protein capable of ...
- Source: drugdu
- 122
- January 18, 2024
Four-Biomarker Panel Could Enable Early Ovarian Cancer Detection

Ovarian cancer remains a significant cause of mortality globally. While advancements in cytoreductive surgery and chemotherapy have improved survival for those with epithelial ovarian cancer, prognosis heavily depends on the stage at diagnosis. Early detection, particularly at stage I, offers a five-year survival rate exceeding 90%. However, this rate drops to around 70% for stage II, where cancer is confined to the pelvis, and declines further for later stages, plummeting to a mere 20% at stage IV. Computational models suggest that detecting ovarian cancer in stages I or II could increase the cure rate by 10-30%. Currently, Cancer Antigen 125 (CA125), a protein found in various cells, including those of ovarian cancer, is the only tumor marker recommended for clinical use in diagnosing and managing ovarian cancer. Now, a new study has shown that a panel of four biomarkers is more sensitive than CA125 alone for early ovarian cancer detection, ...
- Source: drugdu
- 198
- January 18, 2024
Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease. By FRANK VINLUAN A one-time CRISPR-based gene therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics now has an additional FDA approval as a treatment for the rare blood disease beta thalassemia. The affirmative decision announced Tuesday for the therapy, Casgevy, was widely expected following its December approval in sickle cell disease, but it comes more than two months early. The target date for an FDA decision in the beta thalassemia indication was March 30. Casgevy won its first ever regulatory approval in the United Kingdom, a November decision that covered both sickle cell disease and beta thalassemia. Beta thalassemia is an inherited disease in which genetic mutations lead to low levels ...
- Source: drugdu
- 247
- January 18, 2024
Allakos Skin Drug Fails 2 Mid-Stage Tests, Sparks Restructuring to Cut 50% of Staff

Allakos’s lirentelimab did not beat a placebo in separate Phase 2 tests in atopic dermatitis and spontaneous chronic urticaria. A restructuring now turns the biotech’s focus to an early-stage drug candidate also designed to treat inflammation. By FRANK VINLUAN The lead therapeutic candidate of Allakos has failed in two mid-stage clinical trials for inflammatory skin disorders, leading the biotech to halt work on the drug. Allakos is shifting its focus to an earlier-stage program in its pipeline but will do so with fewer staff. A corporate shakeup is shaving about half of the company’s workforce. San Carlos, California-based Allakos aims to treat allergic, inflammatory, and proliferative diseases with antibodies that target receptors on cells that create immune responses in the body. By activating inhibitory receptors, these drugs are intended to stop inflammation. Its most advanced drug candidate was lirentelimab, which was designed to target an inhibitory receptor on mast cells ...
- Source: drugdu
- 149
- January 18, 2024
Roche exec says more pull incentives are needed to tackle AMR

“Pull incentives such as high cost of therapy and longer exclusivity periods, similar to those granted for orphan drugs, are needed to promote the development of new antimicrobials” says Severin Schwan, chairman of the board of directors of Roche. Schwan was speaking about the threat of antimicrobial resistance (AMR) at the World Economic Forum Annual Meeting taking place from 15–19 January 2024 in Davos, Switzerland. Shyam Bishen, head of the Centre for Health and Healthcare at the World Economic Forum, noted at the same discussion that AMR is the third leading cause of death globally and is forecasted to be responsible for 10 million deaths annually in 2050. Schwan said most companies have left the antimicrobial sector as they perceive that there is no sustainable business model. “The research and development subsidiaries offered by various governments to develop antimicrobials are a waste of money and are not worth it to ...
- Source: drugdu
- 176
- January 18, 2024
Shanghai Serum Bio-technology Co., Ltd. voluntarily discloses the announcement of obtaining the ethical review approval for Phase II clinical trial of Anti-Viper Venom Serum

Shanghai Serum Bio-technology Co., Ltd. (hereinafter referred to as the “Company”) has passed the approval of the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, the lead organization of the Phase II Clinical Study of Anti-Viper Venom Serum Injection, and obtained the ethical review approval document. The relevant information is announced as follows: The results of the completed Phase I clinical trial study of Anti-Viper Venom Serum Injection (Registration No. CRT20202621) showed that good safety and tolerability were observed in healthy subjects given different dose groups of Anti-Viper Venom Serum. The results of drug dose, drug concentration, and correlation analysis with effect indicated that the efficacy of the anti-viper venom serum (ability to neutralize viper venom in vitro) was well correlated and dependent on the dose of the test drug administered, and the concentration of the drug in the blood. Based on the positive safety results ...
- Source: drugdu
- 190
- January 18, 2024
Announcement of Changchun Hi-Tech Industrial (Group) Co., Ltd. on the Acquisition of FDA Implied License for Clinical Trials of Drugs by its Controlling Subsidiary

According to the relevant rules of the U.S. Food and Drug Administration (hereinafter referred to as “FDA”), Changchun Hi-Tech Industrial (Group) Co. (hereinafter referred to as “GenSci”) will carry out Phase I clinical trials in the United States for GenSci125 for injection (IND No. 168162), and the relevant information is hereby announced as follows: The Company had issued the ”Announcement on the Approval of the Application for Clinical Trial of GenSci125 for Injection by the Controlling Subsidiary” (Announcement No. 2023-096) on December 15, 2023, obtaining the ”Notification of Approval for Clinical Trial of Drugs” by the State Drug Administration of the PRC in respect of the project of GenSci125 for injection and agreeing to carry out the clinical trial. On December 15, 2023, GenSci obtained the IND confirmation letter from FDA. According to the requirements of the letter, there is an implied license period of 30 days after the receipt ...
- Source: drugdu
- 197
- January 18, 2024

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