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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy has secured US Food and Drug Administration (FDA) approval for non-small cell lung cancer (NSCLC) in the perioperative setting, just weeks after the agency called for an overhaul of perioperative lung cancer trials. This approval is for patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated in the perioperative setting – a term that refers to the time before, during, and after surgery. In a 25 July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised concerns about the design of trials done in this setting. The Imfinzi approval is based on positive data from the Phase III AEGEAN study (NCT03800134), which showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. ...
- Source: drugdu
- 70
- August 20, 2024
McMaster drug trial receives more than $6m to test smallpox vaccine against mpox

Researchers from McMaster University have received $6.7m from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Canadian Institutes of Health Research to assess the effectiveness of a smallpox vaccine in providing protection against mpox after post-exposure. Beginning in August, the Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial (SMART) will assess the effectiveness of the Bavarian Nordic smallpox vaccine, MVA-BN, in more than 1,500 participants in households with laboratory-confirmed mpox infection at sites in the Democratic Republic of Congo (DRC), Uganda and Nigeria. Mpox is a disease caused by infection with a virus known as the monkeypox virus, which is part of the same family as the virus that causes smallpox. Symptoms include fever and headache, as well as painful lesions. In some cases, the disease can lead to bronchopneumonia, sepsis, encephalitis, loss of vision and even death. In the DRC, between June 2023 and 2024, ...
- Source: drugdu
- 50
- August 20, 2024
Study identifies new disease-inducing mechanism for inflammatory bowel disease

Researchers from Newcastle University, Great North Children’s Hospital, Cambridge University Hospital and the universities of Cambridge and Oxford have identified a new disease-inducing mechanism for inflammatory bowel disease (IBD). The study published in the New England Journal of Medicine found that self-directed antibodies attacked interleukin-10 (IL10), an anti-inflammatory protein that controls intestinal immunity, in two patients with early-onset severe IBD. Collectively known as IBD, Crohn’s disease and ulcerative colitis are incurable conditions that involve excessive inflammation in the gut and affect over 500,000 people in the UK, according to Crohn’s & Colitis UK. Supported by the National Institute for Health and Care Research (NIHR), Cambridge Biomedical Research Centre, NIHR Oxford BRC and the Leona M. and Harry B. Helmsley Charitable Trust, and part-funded by the Wellcome Trust, scientists discovered that these antibodies prevented IL10 from binding to its receptor, ultimately causing an increased inflammatory response in patients. The team found ...
- Source: drugdu
- 90
- August 20, 2024
FDA Grants Accelerated Approval to Gilead’s Livdelzi for the Treatment of Primary Biliary Cholangitis

By Don Tracy, Associate Editor Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus. The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead’s treatment for primary biliary cholangitis (PBC) in adults who either have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. According to the company, the approval was based on positive results from the Phase III RESPONSE study, where Livdelzi significantly improved key biochemical markers and reduced pruritus, a debilitating symptom of PBC. Accelerated approval was based on a reduction of ALP.1 “More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, president, The PBCers Organization, ...
- Source: drugdu
- 101
- August 19, 2024
【EXPERT Q&A】Why do import and export enterprises have to do AEO certification?

Drugdu.com expert’s response: The necessity for import-export enterprises to undergo AEO (Authorized Economic Operator) certification primarily stems from the following aspects: I. Enhancing International Competitiveness 1.High International Recognition: AEO certification, a globally recognized standard formulated by the World Customs Organization (WCO), carries international mutual recognition. Enterprises with AEO certification are regarded as secure and reliable trading partners in international trade, thereby enhancing their international credibility and reputation. 2.Priority Customs Clearance: AEO-certified enterprises enjoy preferential treatment such as priority processing and reduced inspections, including diminished time and procedures for customs inspections, border controls, and logistics security. This expedites cargo clearance, shortens the dwell time at customs, and improves both export and import efficiency. II. Reducing Costs and Improving Efficiency 1.Lower Inspection and Audit Frequencies: AEO-certified enterprises benefit from reduced inspection rates and audit frequencies during import-export activities, minimizing unnecessary inconveniences and additional expenses. This helps to lower international trade costs, encompassing ...
- Source: drugdu
- 95
- August 19, 2024
CMS Touts First Negotiated Drug Prices, But Greater Impact Expected in Future Rounds

The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
- Source: drugdu
- 102
- August 19, 2024
Pfizer’s RSV vaccine shows benefit in immuno-compromised adults in study

Pfizer said on Monday its respiratory syncytial virus (RSV) vaccine Abrysvo generated a strong immune response in a late-stage study of four groups of adults aged 18 and older with a compromised immune system. A single 120 microgram dose of the vaccine generated strong neutralising antibodies against both subtypes of RSV, called RSV-A and RSV-B, across all groups in the study, Pfizer said. Abrysvo was well-tolerated in the study and showed a safety profile consistent with findings from other studies of the vaccine, it added. The drugmaker plans to submit the data to regulatory agencies for review. The study tested two doses of Abrysvo in 203 adults across four groups – those with a type of lung cancer, end-stage kidney disease, autoimmune inflammatory disorder, and solid organ transplant recipients – all of whom have compromised immunity and are at risk of developing severe RSV-associated disease. Pfizer’s vaccine is currently approved ...
- Source: drugdu
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- August 19, 2024
Novo Nordisk Education Foundation and RNT medical college to establish India’s first ‘Sickle Cell Wellness Hub’

Novo Nordisk Education Foundation (NNEF), a non-profit organisation set up by Novo Nordisk India, signed a Memorandum of Understanding (MoU) with Rabindranath Tagore (RNT) Medical College, Udaipur to establish a ‘Sickle Cell Wellness Hub’ dedicated to people living with sickle cell disease (SCD). The MoU was signed between Dr Vipin Mathur – Principal & Controller, RNT Medical College and Vikrant Shrotriya – Managing Trustee, Novo Nordisk Education Foundation. Also present at the occasion were Dr R L Suman – Medical Superintendent, MB Government Hospital, Udaipur and Dr Lakhan Poswal – Senior Professor & HOD, Pediatrics and Nodal Officer, SCD Centre of Excellence, RNT medical College, Udaipur. This public-private partnership is aligned to the Government of India’s commitment of eradicating SCD from India by 2047 as part of its National Sickle Cell Anaemia Elimination Mission 2023 [1]. According to the statement released, the Sickle Cell Wellness Hub will offer holistic care ...
- Source: drugdu
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- August 19, 2024
Evotec slashes workforce by 400 people in “difficult market”

German life science company Evotec is cutting 400 jobs as the company continues to deal with ‘a more difficult market environment’.” The company’s CEO Christian Wojczewski has announced an accelerated transformation programme for the company, designed to produce cost savings of at least €40m ($44m) next year, he said. One of the reasons cited by Evotec for this challenging environment includes a high fixed cost base for weaker profitability. Nonetheless, the business outlook for FY 2024 involves a slight rise in revenue projections, increasing from €790m to €820m. This is compared to €781m in FY 2023. In May, the company shut down its gene therapy business after its Q1 2024 group revenues were down by 2%. Evotec said its site in Austria will be closed down as part of the restructuring, which affected 40 employees. The company ventured into the gene therapy arena in April 2020, when it teamed up ...
- Source: drugdu
- 95
- August 19, 2024
Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

SHANGHAI, Aug. 12, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. ...
- Source: drugdu
- 57
- August 19, 2024

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