AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer. By FRANK VINLUAN AstraZeneca is following in the footsteps of some of its big pharmaceutical company peers, plunking down $2 billion to acquire its radiopharmaceuticals partner Fusion Pharmaceuticals. More than adding a pipeline of targeted radiation therapies, AstraZeneca gains the crucial supply chain and manufacturing infrastructure to support them. The sum is an upfront payment. According to the deal terms announced Tuesday, AstraZeneca will pay $21 cash for each Fusion share, representing a 97% premium to Fusion’s closing stock price on Monday. Shareholders of the radiopharmaceutical company could get even more. The deal includes a contingent value right that will pay an additional $3 per share upon achievement of a regulatory milestone. ...
Detecting kidney disease late can lead to severe and even life-threatening issues. Now, new research has found that the genes expressed in human cells harvested from urine closely match those in the kidney, suggesting that these cells could offer a non-invasive approach to better understanding kidney health. This discovery could allow the diagnosis of kidney problems without doing biopsies, making it possible to detect kidney disease earlier and more easily. A team of scientists led by the University of Manchester (Manchester, UK) used a method called transcriptomics to measure the levels of about 20,000 genes in each cellular sediment sample of urine. Transcriptomics helps scientists see which genes are active or inactive, providing insights into how cells adapt to changes in their environment. This molecular-level understanding can lead to more accurate diagnoses and better patient outcomes. The team also had access to the world’s largest collection of human kidney samples ...
Interstitial fluid has many similarities with blood, and its secrets are still being uncovered. A microneedle offers a minimally invasive method to sample this fluid directly under the skin. This tool allows for real-time and continuous monitoring of biomarkers circulating in the body. Despite their small size, just two to three times the width of a human hair and around a millimeter in length, microneedles can make a significant difference in early infection diagnosis and personal health monitoring. Now, researchers have developed improved microneedle technology that enhances the extraction of interstitial fluid by collecting more sample quantities in less time. Sandia National Laboratories (Albuquerque, NM, USA) is leading the way in microneedle research through collaboration with different partners to enhance this technology. Sandia has achieved a breakthrough in interstitial extraction, moving from using multiple needle arrays to a single microneedle technique that collects enough fluid for analysis in just about ...
AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer. By FRANK VINLUANAstraZeneca is following in the footsteps of some of its big pharmaceutical company peers, plunking down $2 billion to acquire its radiopharmaceuticals partner Fusion Pharmaceuticals. More than adding a pipeline of targeted radiation therapies, AstraZeneca gains the crucial supply chain and manufacturing infrastructure to support them. The sum is an upfront payment. According to the deal terms announced Tuesday, AstraZeneca will pay $21 cash for each Fusion share, representing a 97% premium to Fusion’s closing stock price on Monday. Shareholders of the radiopharmaceutical company could get even more. The deal includes a contingent value right that will pay an additional $3 per share upon achievement of a regulatory milestone. That ...
Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don’t cause any problems. However, for individuals with certain underlying health conditions, these bacteria can lead to lung infections, showing symptoms similar to those of tuberculosis. Such infections can lead to chronic coughing, sometimes with blood, and scarring that increases susceptibility to respiratory infections like bronchitis and pneumonia. Diagnosing and treating these infections is a lengthy process due to the slow growth rate of the bacteria. With the number of NTM infection cases rising each year, partly due to climate change, there’s a pressing need for quick and precise diagnostic methods. Researchers have now introduced a CRISPR-based testing platform capable of identifying NTM infections using blood samples, providing results in as little as two hours. Researchers at Tulane University (New Orleans, LA, ...
Don Tracy, Associate Editor In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment. Johnson & Johnson (J&J) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) in earlier lines of treatment for adult patients with relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including both a proteasome inhibitor and an immunomodulatory agent, and who are also refractory to lenalidomide. The 11-0 unanimous vote in favor of the treatment resulted from Phase III CARTITUDE-4 study data, which showed an encouraging risk-benefit evaluation for its proposed indication.1 “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, VP, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, in a press ...
BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
Don Tracy, Associate Editor Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA has approved BeiGene’s Tevimbra (tislelizumab-jsgr) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA based the approval on findings from the Phase III RATIONALE 302 trial (NCT03430843), which showed a significant survival benefit with Tevimbra compared to chemotherapy, with an overall survival rate of 8.6 months compared with 6.3 months in patients administered chemotherapy. Further, the treatment was found to be safer altogether, with manageable adverse effects.1 “Today’s FDA approval of Tevimbra for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our [biologics license application] for first line ESCC patients, represents a significant step in our commitment ...
ZHUHAI, China, March 15, 2024 /PRNewswire/ — On March 14, 2024, Biotheus Inc. (Biotheus), a clinical-stage biotech company focusing on the discovery and development of biologics for oncology and inflammatory diseases, and Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma,03692.HK), China’s leading innovation-driven pharmaceutical company, jointly announced that the two parties will further expand their strategic collaboration, following their current partnership since 2022. Biotheus will grant Hansoh Pharma a license to use the proprietary anti-EGFR/cMet bispecific antibody PM1080/HS-20117 independently developed by Biotheus for the development of antibody-drug conjugates products (ADC Product). Under the terms of the agreement, Hansoh Pharma will obtain exclusive worldwide rights from Biotheus to use PM1080/HS-20117 for the development, production, and commercialization of ADC Product, with the right of sublicense. Biotheus will be eligible to receive up to 5 billion RMB in upfront and success-based milestones for ADC Product, as well as tiered royalties based on global net ...
SHENZHEN, China, March 15, 2024 /PRNewswire/ — ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC. HNSCC has become a growing public health concern, with increases in incidence ...
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