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AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
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- April 11, 2024
Bristol Myers Squibb Reveals Promising Data for KarXT, a Potential Treatment for Schizophrenia

Don Tracy, Associate Editor A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia. Bristol Myers Squibb announced results from its Phase III EMERGENT-4 trial analyzing the long-term efficacy, safety, and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia, which was showcased at the Annual Congress of the Schizophrenia International Research Society (SIRS). Additionally, the company revealed promising pooled data from EMERGENT-4 and EMERGENT-5 for the long-term safety, tolerability, and metabolic effects of KarXT in schizophrenia over 52 weeks. EMERGENT-4 is a 52-week, open-label extension trial assessing long-term efficacy, safety, and tolerability of KarXT in adults who completed earlier phases of the trial for schizophrenia. Investigators found that over 75% of patients administered KarXT achieved a 30% improvement in symptoms.1 “We are pleased to see a continued and consistent meaningful reduction ...
- Source: drugdu
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- April 11, 2024
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations ranges from mild cases with minimal symptoms to severe disorders like sickle cell disease and Hb Bart’s hydrops fetalis, which can cause extensive organ damage and necessitate lifelong blood transfusions. Capillary electrophoresis has been established as a reliable method for newborn screening of hemoglobin disorders, offering high-quality outcomes. Now, a next-generation instrument dedicated to newborn hemoglobin screening offers a smooth workflow and excellent analytical capabilities. Sebia’s (Lisses, France) CAPILLARYS 3 DBS instrument is an automated, multitasking capillary electrophoresis instrument that uses 12 capillaries simultaneously for hands-free electrophoretic separation at high throughput. Designed to detect both standard (F and A) and abnormal hemoglobins (S, C, E, D, and Bart’s) in dried blood samples collected on filter paper from newborns, this instrument provides ...
- Source: drugdu
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- April 11, 2024
New Diagnostic System Achieves PCR Testing Accuracy

While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex chemical reactions which are crucial for amplifying viral DNA or RNA, a process that involves generating multiple copies of the genetic material that can also create and amplify error. Additionally, PCR tests can detect only nucleic acids, the material comprising DNA and RNA, but can be of great use in detecting other biomarkers such as proteins in the case of certain diseases. Now, a groundbreaking diagnostic system offers the ability to accurately identify SARS-CoV-2 and Zika virus with a precision matching or surpassing that of PCR tests, but significantly reducing the time and complexity involved in diagnosis. The new system developed at UC Santa Cruz (Santa Cruz, CA, USA) in collaboration with the Texas Biomedical Research Institute ...
- Source: drugdu
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- April 11, 2024
Pfizer meets Phase III primary endpoints for RSV vaccine Abrysvo

Pfizer has reported positive top-line results from its Phase III MONeT study (NCT05842967) evaluating the efficacy of single-dose Abrysvo for adults at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). As per the 9 April press release, Abrysvo met its co-primary immunogenicity and safety endpoints, with patients demonstrating non-inferior RSV-A and RSV-B neutralising responses compared to the Phase III RENOIR study (NCT05842967) where the vaccine previously showed efficacy. Compared to pre-vaccination, the vaccinated patients also demonstrated a minimum of a four-fold increase in serum-neutralising titers for RSV-A and RSV-B a month after being vaccinated. The MONeT trial did not identify any new safety signals for Abrysvo. The pharma giant plans to publish the findings in a peer-reviewed journal and submit the results to regulatory agencies in a bid to expand the vaccine’s label from its current indication to include adults 18 years and older, the ...
- Source: drugdu
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- April 11, 2024
Oryzon wins FDA approval to begin SCLC treatment trial

Oryzon Genomics is set to commence a Phase I/II clinical trial of iadademstat (ORY-1001) plus immune checkpoint inhibitors (ICI) in patients with first-line small cell lung cancer (SCLC). The development comes after the US Food and Drug Administration (FDA) cleared the Spain-based biotech’s investigational new drug application (IND) to initiate the study. The Phase I/II trial (NCT06287775) will be conducted and sponsored by the National Cancer Institute (NCI), enrolling 45-50 patients. In the first phase, patients will receive iadademstat on days 1, 8, 15, and 22 or days 1 and 15 of each cycle. Patients will also continue to receive their initial ICI treatment, Tecentriq (atezolizumab) intravenously (IV), or Imfinzi (durvalumab) IV over 60 minutes on day one of each cycle. Cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. In the second phase of the study, patients are randomised to two different arms ...
- Source: drugdu
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- April 11, 2024
Culmination Bio and BillionToOne partner to advance cancer diagnosis

Culmination Bio has announced a partnership with BillionToOne to develop and advance diagnostic tests in oncology that are accessible to all. Both companies will work together to facilitate the development and validation of robust and impactful oncology diagnostics. According to the Centers for Disease Control, skin cancer is currently the most common type of cancer in the US, responsible for more than 9,500 new cases every day, followed by lung cancer, prostate cancer and breast cancer. The molecular diagnosis company, BillionToOne, is developing these new diagnostics in an effort to address the challenges associated with accurately profiling cancer to assess the best treatment and monitor responses to determine the effectiveness of the cancer treatment. As part of the agreement, the data and technology company will use its Data Lake and patient recruitment abilities to help BillionToOne validate the clinical performance of two new diagnostic tests: Northstar Select, an ultra-sensitive, NGS-based ...
- Source: drugdu
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- April 11, 2024
US researchers reveal positive results of personalised vaccine for liver cancer

Researchers from the Johns Hopkins Kimmel Cancer Center and its Convergence Institute have revealed promising results of a personalised vaccine for liver cancer in a clinical trial. Results from the study were published in Nature Medicine and were recently presented at the American Association for Cancer Research’s annual meeting. Recognised as the most common type of liver cancer, hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related deaths globally, with fewer than one in ten patients surviving five years after diagnosis. Researchers took tumour biopsy cells from 36 HCC patients to identify cancer-associated genetic mutations in the tumour to manufacture a personalised vaccine containing DNA for selected mutated genes. Involving 36 patients living with HCC, investigators added a personalised anti-tumour vaccine to Merck & Co’s – known as MSD outside the US and Canada – PD-1 inhibitor therapy, Keytruda (pembrolizumab), a standard immunotherapy. The personalised vaccine works by ...
- Source: drugdu
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- April 11, 2024
【EXPERT Q&A】What qualifications are required to sell a Class of medical devices?

Drugdu.com expert’s response: To sell Class I medical devices, you typically need to obtain the following qualifications: Medical Device Operation License: According to the “Regulations on the Supervision and Administration of Medical Devices,” any unit or individual engaged in activities such as production, operation, use, or technical services of medical devices must obtain a medical device operation license to operate medical devices. Business License: As a business entity, you need to have a valid business license to engage in legal business activities. Other Relevant Qualifications: Depending on the specific situation and requirements, you may also need to obtain other relevant qualifications such as medical device registration certificate, production license, etc.
- Source: drugdu
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- April 11, 2024
KOREA PHARM & BIO 2024

Organiser: KFDA、KPMA Time:23 – 26 April 2024 address：217-59 Kintekseu-ro, Daehwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do,Korea Exhibition hall: KINTEX Product range: Pharmaceutical: Pharmaceutical raw materials, API, pharmaceutical fine chemicals, intermediates, pharmaceutical additives, pharmaceutical agents, natural extracts, biotechnology, pharmaceutical outsourcing and services, laboratory equipment, pharmaceutical equipment, etc Chemical: chemical raw materials, chemical equipment, instrumentation, automatic control technology, heat exchanger, crystallization, gas absorption, drying, filtration, centrifuge, dust removal, chemical reactor, mill, blender, etc Cosmetics: cosmetic raw materials, cosmetic additives, functional materials, natural extracts, etc About KOREA PHARM & BIO： The KOREA PHARM & BIO event includes a variety of events, including a policy briefing on raw materials and pharmaceuticals, an export fair, and a variety of pharmaceutic-related seminars. The broad development space creates good opportunities for companies interested in exploring and developing the Korean market, and will undoubtedly become the best platform for companies to reach deals.
- Source: drugdu
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- April 11, 2024

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