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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
- 80
- 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
- 99
- 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
- 94
- July 29, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 121
- 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
- 83
- July 29, 2024
【EXPERT Q&A】What is the specific process of medical device product registration?

Drugdu.com expert’s response: The medical device product registration certificate is a necessary credential for legal marketing and sales of medical device products. Its application process involves multiple stages, aiming to ensure the safety, effectiveness, and compliance of the products. Below is a detailed breakdown of the specific process for obtaining a medical device product registration certificate, divided into six phases. I. Preparation Before applying for registration, applicants need to thoroughly understand relevant national regulations and policies, including the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Administration of Medical Device Registration,” to ensure product compliance. At the same time, prepare necessary application materials, which include but are not limited to: 1.Enterprise Qualification Certificates: such as business licenses, medical device production licenses, etc. 2.Product Technical Data: detailing technical specifications, performance parameters, production processes, quality standards, etc. 3.Product Instructions: comprehensively describing usage methods, precautions, warning information, ...
- Source: drugdu
- 94
- 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/
- 115
- 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
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- July 27, 2024
New Drug Marketing Application for BBM-H901 Injection, a Gene Therapy Product for Hemophilia B, Accepted by the National Drug Administration

Takeda China and Conviction Pharmaceuticals Group (hereinafter referred to as Conviction Pharmaceuticals) announced today that the National Drug Administration (NDA) has formally accepted the New Drug Application (NDA) for BBM-H901 Injection for the treatment of adult patients with Hemophilia B. BBM-H901 Injection is a recombinant adeno-associated virus (AAV) gene therapy product that was independently developed and manufactured by Conviction Pharmaceuticals, and the commercialization of this product will be undertaken by Takeda China in the future. Takeda China is responsible for the commercialization of the product in Mainland China, Hong Kong, China and Macau, China. This milestone development means that the product is expected to bring new treatment options for hemophilia B patients in China. Zhang Lei, the lead investigator of the registered clinical study of BBM-H901 injection and a professor at the Hospital for Hematological Diseases of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical ...
- Source: drugdu
- 110
- July 26, 2024
AstraZeneca grows oncology portfolio with Pinetree’s EGFR degrader

AstraZeneca has signed a licensing agreement with Pinetree Therapeutics for a preclinical epidermal growth factor receptor (EGFR) degrader candidate, potentially worth more than $545m. AstraZeneca will pay $45m upfront for global developmental and commercialisation rights for the pan-EGFR degrader, and Pinetree will also be in line to receive up to $500m in milestone-based payments along with tiered royalties on sales. “[The] pan-EGFR degrader was developed from AbReptor, our proprietary multispecific antibody platform and has demonstrated promising preclinical anti-tumour activity in drug-resistant and tyrosine kinase inhibitor (TKI)-resistant tumours, as well as enhanced activity when used in combination with current EGFR inhibitors,” said Dr Hojuhn Song, founder and CEO of Pinetree. Targeted protein degraders, often called molecular glues, have been a growing area of interest in recent years. Most of these therapies are developed in oncology. According to GlobalData’s drug database, over 200 therapies in development have been classified as molecular glue ...
- Source: drugdu
- 94
- July 26, 2024

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