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AstraZeneca Joins Radiopharma Deals Spree With $2B Fusion Acquisition

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 ...
- Source: drugdu
- 154
- March 21, 2024
FDA Grants Accelerated Approval to Takeda’s Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
- Source: drugdu
- 174
- March 21, 2024
BIO-THERA Signs License and Commercialization Agreement with SteinCares for Two Investigational Biosimilars

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has signed license and commercialization agreements with SteinCares for two investigational biosimilars. The Company today announced that it has entered into a license and commercialization agreement with SteinCares for two investigational biosimilars. Under the terms of the agreements, SteinCares will have exclusive distribution and marketing rights for the two biosimilars in Brazil and the rest of Latin America. Under the terms of the agreements, BIO-THERA will be responsible for the development, manufacturing, commercial supply and filing of marketing applications with the U.S. FDA and the European EMA for the two biosimilars, and SteinCares will be responsible for the filing of marketing applications for the two biosimilars in Brazil and the rest of Latin America, and for their commercialization. SteinCares is familiar ...
- Source: drugdu
- 196
- March 21, 2024
ALS Association partners with myTomorrows to improve clinical trial accessibility

The fatal motor neurone disease currently does not have a cure available to treat patients The ALS Association and myTomorrows have partnered to improve the accessibility of future clinical trials for patients living with amyotrophic lateral sclerosis (ALS). The aim of the partnership is to ensure that patients living with the condition and physicians are up-to-date with information about pre-approval treatment options and clinical trials. ALS is a fatal motor neurone disease that is characterised by the progressive degeneration of nerve cells in the spinal cord and brain, affecting the voluntary control of arms and legs. Usually fatal within five years with no cure available, searching for clinical trials for ALS patients is challenging due to its day-to-day implications and rapid escalation. The US-based ALS Association and myTomorrows aim to tackle these challenges and make it easier for patients and their families to participate in clinical trials. The ALS Association ...
- Source: drugdu
- 177
- March 21, 2024
KCL researchers develop pipeline to create customisable cell culture device creations

The SOL3D pipeline addresses research challenges in relation to equipment, expertise and cost Scientists from King’s College London’s (KCL) UK Dementia Research Institute’s (UK DRI) have developed a process to enable custom cell culture device creation. Published at PLOS Biology, the soft-lithography on 3D vat polymerised (SOL3D) pipeline is cheaper, versatile, highly reproducible and modifies the microfabrication of cell culture devices to produce customised systems. Cell culture devices are designed to support physical environments for cells within the laboratory setting, enabling scientists to observe cell growth and how they interact with each other under different test conditions. Currently, wet labs use commercially developed microdevices, which are expensive and do not allow for customisation, ultimately narrowing the scope of research that can be done. The SOL3D pipeline, instead, offers the potential to create bespoke designs and addresses challenges in relation to equipment, expertise and cost. Researchers used bioengineering and microfabrication expertise ...
- Source: drugdu
- 103
- March 21, 2024
March 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the ...
- Source: drugdu
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- March 21, 2024
K Med Expo Vietnam 2024

Organiser: KINTEX Co.,Ltd. Time:13 – 15 June 2024 address：Lawrence S. Ting Building801 NguyenVan LinhParkway,Dist. 7 Ho Chi Minh City Vietnam Exhibition hall: Saigon Exhibition & Convention Center Product range: Medical equipment: diagnostic, examination and treatment equipment, accident and emergency equipment, diagnostic, disinfection and disposal systems, electronic medical equipment, medical technology, medical furniture and equipment, rehabilitation equipment, orthopaedic supplies, medical consumables, dental materials and equipment Pharmaceutical equipment: drugs; Machinery, equipment and technologies for research, development and production of pharmaceutical materials and packaging, products and equipment provided by the R&D department, beauty equipment, beauty care and high-quality medical services About K Med Expo Vietnam： Vietnam Ho Chi Minh Medical Equipment and Pharmaceutical Exhibition (K Med Expo) has gradually become the most professional international exhibition in the field of medicine and medical treatment in Vietnam. Due to its changeover and high-quality professional audience, it has attracted more and more foreign enterprises, including China, to ...
- Source: drugdu
- 231
- March 20, 2024
【EXPERT Q&A】What is temporary mining of medical consumables?

Drugdu.com expert’s response: “The procurement of medical consumables on an ad hoc basis” typically refers to the acquisition of medical consumables by healthcare institutions for clinical use, such as surgical instruments, dressings, syringes, catheters, and so forth. These consumables are essential for the daily provision of medical services in healthcare facilities. However, due to specific patient needs, types of procedures, and other factors, healthcare institutions may procure these consumables as needed during clinical practice rather than purchasing them in bulk beforehand. The term “ad hoc procurement” or “clinical procurement” implies that healthcare institutions purchase the necessary medical consumables based on current clinical demands and patient conditions. This ensures the smooth delivery of medical services. Unlike pre-planned routine procurement, clinical procurement is more flexible, allowing adjustments to be made promptly to meet specific medical needs as they arise.
- Source: drugdu
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- March 20, 2024
New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

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, ...
- Source: drugdu
- 152
- March 20, 2024
Groundbreaking Test Monitors Radiation Therapy Toxicity in Cancer Patients

The concentration of circulating cell-free DNA (cfDNA) in the bloodstream is an important indicator that can help track how well cancer treatments are working. Before starting treatment, measuring cfDNA levels can give doctors a snapshot of the extent of the cancer’s spread in the body. High levels of cfDNA often mean the cancer is widespread or aggressive. As treatment goes on, doctors can keep an eye on cfDNA levels to see if the treatment is effective. A drop in cfDNA levels could mean the treatment is working and the tumor is getting smaller. But if cfDNA levels remain unchanged or rise, it might mean the treatment isn’t working, and the cancer is still growing or has become resistant to treatment. Now, a simple blood test monitors this liquid biomarker in real time to track how well a cancer treatment is working. DiaCarta’s (Pleasanton, CA, USA) RadTox Test is a liquid ...
- Source: drugdu
- 142
- March 20, 2024

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