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Talent Management Strategies for Post-Milestone Growth

By Tracy Duberman, PhD Insights from Takeda, Jazz, Nestlé Health Sciences, Humana, and other healthcare executives Milestones such as major acquisitions, FDA approvals for new therapies, or obtaining Series C funding are transformative events for pharmaceutical organizations. These triumphs come with nuanced challenges including how to integrate new teams while retaining core talent and how to sustain morale during rapid scaling. Pharma leaders managing talent post milestones need to focus on assessing future talent needs, implementing strategic talent acquisition, onboarding new hires to the company’s culture, leveraging internal talent mobility, prioritizing DE&I initiatives, recognizing employee performance, and focusing on employee well-being. Below are talent management strategies to consider for post-milestone growth. Projecting talent needs for future success: It is important to assess the impact of any large-scale change on both current and future talent and to have a data-informed approach to effectively manage talent during transformative phases. Understanding current talent ...
- Source: drugdu
- 76
- July 29, 2024
FDA committee proposes overhaul of perioperative lung cancer trials

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has called for changes in how clinical trials are conducted for treatments involving surgery for early-stage non-small cell lung cancer (NSCLC). In the 25 July meeting, the ODAC highlighted that it’s important to separately evaluate the effectiveness of each part of the treatment process, which includes pre-operative and post-operative phases. The committee meeting – which ended with a 11–0 vote in favour of changing how perioperative trials are run– came after AstraZeneca proposed to use Imfinzi (durvalumab) as a treatment with chemotherapy both before and after surgery. The pharma giant conducted the Phase III AEGEAN study (NCT03800134) to support this label expansion. The committee did not vote on Imfinzi’s approval in this indication, but the overall majority suggested that it should be approved. Following a lengthy discussion as to whether there should be another trial, Ravi Madan, medical ...
- Source: drugdu
- 90
- July 29, 2024
EMA backs Wegovy cardiovascular label update as Novo seeks EU coverage

The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg). The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe. Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes. The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant ...
- Source: drugdu
- 82
- July 29, 2024
Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adjusting the marketing authorisation of Bavarian Nordic’s smallpox and mpox vaccine Imvanex (MVA-BN), based on the inclusion of real-world effectiveness data. The recommendation is following a type II variation request by the Danish vaccine maker, as per a 26 July press release. A type II variation is when a major change is needed in the marketing authorisation for a medicine approved in Europe. Bavarian Nordic originally received approval for the vaccine, also known under the brand names Jynneos and Imvamune, in 2013 for smallpox prevention, which was then extended in 2022 to include mpox. The approval was before the mpox outbreak in 2022 and was therefore based on data in non-human primates and immunogenicity insights from healthy volunteers. The results demonstrated that Imvanex had a good safety profile and induced immune responses that were non-inferior to ...
- Source: drugdu
- 81
- July 29, 2024
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 110
- July 27, 2024
Sage and Biogen Halt Phase II Study After Novel Drug Shows No Significant Improvement in Treating Essential Tremor

Image Credit: Adobe Stock Images/Creative Cat Studio Data from the Phase II KINETIC 2 study, which evaluated SAGE-324 (BIIB124) as a treatment for essential tremor (ET), show the drug did not achieve the trial’s primary objectives. According to Sage Therapeutics and Biogen, the study aimed to determine the dose-response relationship of SAGE-324 by assessing changes from baseline to day 91 in the TETRAS Performance Subscale Item 4 total score, measuring upper limb tremor severity. Results found that SAGE-324 offered no statistically significant improvement across different doses compared to placebo. As a result, both companies have decided to halt the ongoing open-label safety study and cease further clinical development of SAGE-324 for ET.1 “There has been little innovation in the pharmacological treatment of essential tremor over the past 50 years, and people living with this debilitating condition have a pressing need for new treatment options. We are disappointed that the results ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 114
- July 27, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 83
- July 26, 2024
AI Model Identifies Breast Tumor Stages Likely To Progress to Invasive Cancer

Ductal carcinoma in situ (DCIS) is a non-invasive type of tumor that can sometimes progress to a more lethal form of breast cancer and represents about 25% of all breast cancer cases. Between 30% and 50% of DCIS patients may develop an invasive stage of cancer, yet identifying which tumors will progress is still a challenge due to unknown biomarkers. Current diagnostic practices include multiplexed staining or single-cell RNA sequencing to determine DCIS stages in tissue samples, but these methods are costly and not widely used. This has led to potential overtreatment of patients with DCIS. Now, a new artificial intelligence (AI) model can distinguish different stages of DCIS from inexpensive and readily available breast tissue images. The model developed by an interdisciplinary team of researchers from MIT (Cambridge, MA, USA) and ETH Zurich (Zurich, Switzerland) was trained and tested using one of the largest datasets of its kind ...
- Source: https://www.labmedica.com/pathology/articles/294801919/ai-model-identifies-breast-tumor-stages-likely-to-progress-to-invasive-cancer.html
- 67
- July 26, 2024
Handheld Device Puts Power of Lab-Based Diagnostic Testing in the Palm of Your Hand

Many common tests for infectious diseases work by detecting either antigens related to the virus or antibodies created in response to the infection. These tests, which now include widely used COVID-19 rapid antigen tests, offer the advantages of speed and broad availability. However, polymerase chain reaction (PCR) tests still surpass these in terms of accuracy, reaching nearly 100%. PCR tests, considered the gold standard in infectious disease diagnostics, excel because they detect a pathogen’s genetic material like RNA directly. This capability increases specificity, reducing the likelihood of false positives. PCR can also amplify minimal amounts of genetic material, allowing it to detect infections at very low levels. Yet, PCR requires specialized skills and expensive equipment, which limits its availability, particularly in low-resource settings. Researchers at the University of Connecticut (Storrs, CT, USA) have now developed a platform technology that incorporates PCR-like capabilities within a handheld device, as detailed in ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801920/handheld-device-puts-power-of-lab-based-diagnostic-testing-in-the-palm-of-your-hand.html
- 112
- July 26, 2024
【EXPERT Q&A】What qualifications do foreign trade enterprises need to agent drug export?

Drugdu.com expert’s response: The qualifications required for foreign trade enterprises to act as agents for pharmaceutical exports primarily encompass the following aspects: I. Basic Qualifications 1.Foreign Trade Management Right: Foreign trade companies must possess general foreign trade import and export management rights, which serve as the fundamental prerequisite for acting as agents for pharmaceutical exports. This right permits the company to engage in or act as an agent for the import and export of various goods and technologies, except for those commodities and technologies whose import and export are restricted or prohibited by the state. 2.Registration: Foreign trade companies need to register with relevant government departments. For instance, they must register with the Ministry of Foreign Trade and Economic Cooperation to obtain import and export qualifications and with the Entry-Exit Inspection and Quarantine Bureau to acquire a quarantine registration code. These registrations are crucial steps to ensure compliance with regulations ...
- Source: drugdu
- 72
- July 26, 2024

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