media – Page 269 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

HilleVax slashes workforce by 40% after norovirus vaccine trial failure

US-based vaccine company HilleVax is slashing its workforce by 40% after its lead vaccine failed a Phase IIb study last month. HilleVax announced that it will let go of 41 employees, after a Phase IIb trial (NCT05836012) with its norovirus vaccine, HIL-214, failed to meet primary and secondary endpoints. The company’s stock plummeted by more than 80% following the 8 July announcement of the failed results. The vaccine showed an efficacy of 5% in the 2,800 infants enrolled in the study aged four months of age at the time of enrolment in the US and Latin American countries, who had norovirus-related acute gastroenteritis (AGE). The study did not meet the key endpoint of demonstrating efficacy against moderate or severe AGE events caused by the GI.1 or GII.4 norovirus genotypes. The experimental vaccine had previously shown success in adults, with one Phase IIb field efficacy trial (NCT02669121) in 4,712 adults showing ...
- Source: drugdu
- 299
- August 3, 2024
Routine Blood Tests Could Speed Up Cancer Diagnosis for People with Abdominal Symptoms

Early detection is critical for successful cancer treatment. Yet, many patients with cancer visit their primary care providers with vague symptoms that could result from various benign conditions, complicating the determination of who needs further diagnostic testing or a referral. Most existing guidelines highlight specific “alarm” symptoms for different cancers to guide referrals, but advice on nonspecific symptoms that span multiple cancer types is scarce. Now, a new study has found that incorporating data from routine blood tests could improve cancer risk assessment for patients presenting with abdominal symptoms. Conducted by researchers at University College London (London, UK), the study utilized data from the UK Clinical Practice Research Datalink, examining over 470,000 patients aged 30 and older who consulted their general practitioner for abdominal pain or bloating. Within one year of these consultations, about 9,000 patients with abdominal pain and 1,000 with bloating were diagnosed with cancer. The study assessed ...
- Source: drugdu
- 206
- August 3, 2024
Cutting-Edge AI Analyzes Blood Samples to Predict Disease 10 Years Before Diagnosis

Scientists have developed an advanced artificial intelligence (AI) approach that can predict the likelihood of developing age-related conditions such as Alzheimer’s and heart disease up to a decade before symptoms manifest. By analyzing blood samples from over 45,000 individuals using machine learning, researchers identified specific protein patterns associated with an increased risk of disease. This capability to predict the probability of developing a health condition before any symptoms are observed could potentially enhance personalized medicine by providing early warnings, thereby opening doors for preventative interventions. Researchers from the University of Edinburgh (Edinburgh, UK) participated in a study that used data from the UK Biobank, which contains genetic and health information from half a million UK participants. They applied AI and machine learning to detect protein patterns in blood that correlate with the onset of common ailments including Alzheimer’s, heart disease, and type 2 diabetes. The analysis was based on medical ...
- Source: drugdu
- 385
- August 3, 2024
Biotech Startup AIRNA Adds $60M to Advance RNA-Editing Therapy for Rare Protein Deficiency

AIRNA’s therapy for alpha1 antitrypsin deficiency, or AATD, edits RNA to address the underlying cause of this rare inherited disease. Wave Life Sciences and Korro Bio are both further along in the development of RNA-editing therapies for AATD, but AIRNA claims its therapy could be best in class. By Frank VinluanA particular protein deficiency that leads to liver and lung damage is currently treatable only with decades-old therapies that all have limitations. Biotech startup AIRNA is part of a field of companies developing novel treatments for this inherited disorder, and it aims to stand apart with a genetic medicine it contends could become best in class. AIRNA is preparing to advance this program to clinical testing and on Wednesday it revealed a fresh round of $60 million to support its plans. The disease that Cambridge, Massachusetts-based AIRNA aims to treat is alpha-1 antitrypsin deficiency, or AATD. This rare disease, affecting ...
- Source: drugdu
- 473
- August 3, 2024
Daiichi Sankyo, Merck Launch Phase III Trial Evaluating Safety, Efficacy of Ifinatamab Deruxtecan in Patients with Relapsed Small Cell Lung Cancer

By Don Tracy, Associate Editor IDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small cell lung cancer. Daiichi Sankyo and Merck have commenced the IDeate-Lung02 Phase III clinical trial, which aims to compare the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) vs. physician’s choice of chemotherapy in patients with relapsed small cell lung cancer (SCLC) following disease progression with only one prior line of platinum-based chemotherapy. According to both companies, the initiation of the trial was based on results from a subgroup analysis of the IDeate-PanTumor01 Phase I/II trial of ifinatamab deruxtecan, which was presented at the 2023 World Conference on Lung Cancer.1 “Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo, in a press release. “The IDeate-Lung02 trial is an important next step as we ...
- Source: drugdu
- 280
- August 3, 2024
【EXPERT Q&A】What are the FDA-approved Consensus Standards for medical devices?

Drugdu.com expert’s response: FDA-recognized consensus standards for medical devices are a set of standards recognized by the U.S. Food and Drug Administration (FDA). These standards are developed by standardization organizations such as ISO, IEC, ASTM, and others, aiming to ensure the safety, effectiveness, and quality of medical devices. These standards cover various aspects of medical devices, including design, manufacturing, testing, clinical evaluation, and risk management. Ⅰ.Source of Standards: Consensus standards are usually developed by professional standard organizations like the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and American Society for Testing and Materials (ASTM). These organizations, with the participation of a wide range of industry experts and stakeholders, create internationally recognized technical requirements and guidelines. Ⅱ.FDA Recognition: The FDA reviews and recognizes these standards, considering them to meet the FDA’s regulatory requirements. Recognized standards are listed in the FDA’s “Recognized Standards” list. Manufacturers can refer to these standards ...
- Source: drugdu
- 537
- August 2, 2024
NRx Receives Response From FDA Over Testing Use of Ketamine for Suicidal Depression in Adolescents

By Mike Hollan The company announced that it will conduct research based on guidance from the agency. NRx Pharmaceuticals announced that it has received a response from FDA over its proposed plan to study the impact of ketamine (NRX-100) as a treatment for suicidal depression in adolescents.1 Congress had previously stated that this is a requirement before NRx can filing a new drug application (NDA) for the use of ketamine to treat suicidal depression. According to NRx, it will work with Hope Therapeutics to conduct a clinical trial on ketamine’s use for this condition. The study will include participants aged 9-17, but it will not be required to include younger participants. The companies will also conduct studies involving animals to determine the safety of ketamine usage in adolescents. In a press release, NRx Pharmaceuticals chairman and HOPE Therapeutics co-CEO Prof. Jonathan Javitt said, “Youth suicide has reached crisis proportions in ...
- Source: drugdu
- 226
- August 2, 2024
FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
- Source: drugdu
- 375
- August 2, 2024
PharmaLab Japan

Organiser：Reed Exhibitions Time：July 9-11, 2025 address： 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: General Exhibition Area: Cell biology-related products, drug research-related products, various equipment, consumables, reagents, bioinformatics-related products, bioimaging equipment, software, databases, biological resources, biomaterials, biotech clusters, investment, industrial upgrading, etc. Regenerative Medicine Research Area: Cell culture, cell production products/services, regenerative medicine, cellular medicine, etc. Contract Services Area: Contract research and development (CRD), testing, analysis, contract expression, synthesis, refinement, clinical research CMO, CRO, SMO, technology transfer TLO, IP consulting, etc. Precision Processing Area: Precision/fine processing technologies, micro-chemical engineering (microTAS, Bio MEMS, biochips, biosensors), microchannels, microsystems, etc. About PharmaLab Japan： PharmaLab Japan is one of Asia’s leading exhibitions for pharmaceutical laboratories. With 250 highly anticipated conferences/seminars, it offers attendees the best platform to learn about life sciences. As a comprehensive biotechnology exhibition, it is widely recognized in the industry and brings together ...
- Source: drugdu
- 396
- August 2, 2024
FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder

By Don Tracy, Associate Editor Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says. Image Credit: Adobe Stock Images/Mohammad Xte The FDA has approved Luye Pharma Group’s Erzofri (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. According to the company, the treatment is the first patented paliperidone palmitate long-acting injection developed in China to be approved in the United States. The product was granted a US patent in 2023, set to expire in 2039, and was approved as a new drug under the 505(b)(2) pathway.1 The approval is based on results from the company’s pivotal United States study of Erzofri.1 “The purpose of developing innovative formulations is to address unmet clinical needs, which includes covering aspects such as drug efficacy, compliance issues and side effects, among others. With a focus on ...
- Source: drugdu
- 433
- August 1, 2024

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