PharmaFocus Today – Page 76 – media

The Need for Contextualization and Cloud-based Integration

Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes. By Harlan KnappBuilt-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the importance of the accuracy and reliability of data across supply chains. Yet, the difficulty of achieving this milestone can still be underestimated by drug sponsors, especially when working with manufacturing partners. Although organizations are expected to demonstrate full governance of their data across the product lifecycle, their access to process data remains limited, which hinders early risk detection as well as the scalability of manufacturing. With agile manufacturing networks, novel therapeutic modalities such as mRNA vaccines and cell and gene therapies, the single-source manufacturing model using on-premise/siloed infrastructure can have an adverse ...
- Source: drugdu
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- July 6, 2024
PrimeRx Launches Digital Platform for Pharmacy Drug Ordering

By Mike Hollan The platform is similar to other recent digital platforms in that it is designed to reduce drug costs. One of the main issues impacting the pharmaceutical industry is the cost of medications. Recently, several digital platforms have launched with the mission of providing more competition by providing purchasers with more options for buying drugs. While the most prominent of these platforms have been based on a direct-to-consumer model, there are other platforms that are designed for pharmacies to use as well. PrimeRX announced the launch of a new platform aimed at pharmacies named PrimeRX MARKET.1 This platform will provide users with access to over 40 different drug suppliers, along with the ability to place all of their orders through one platform, and provide research on drug prices. In a press release, PrimeRx CEO Ketan Mehta said, “We are thrilled to introduce PrimeRx MARKET to our solutions portfolio. ...
- Source: drugdu
- 85
- July 6, 2024
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on July, 03 2024, Asiyah Nawab, Pharma Analyst at GlobalData, offers her view: “Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life,” states Nawab “After reviewing the data published from Sanofi/Regeneron’s two landmark phase 3 studies (BOREAS and NOTUS), Dupixent (dupilumab) was able to significantly reduce moderate or ...
- Source: drugdu
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- July 6, 2024
GSK buys COVID, influenza vaccines from retrenching CureVac

British drugmaker GSK on Wednesday, July 4 2024, bought partner CureVac out of their alliance on influenza and COVID-19 vaccine development, boosting its messenger RNA credentials and extending the German biotech company’s financial lifeline. According to the statement, GSK, will take control of CureVac’s leading experimental vaccines to fight infections, including seasonal flu and bird flu. It will pay CureVac 400 million euros ($430 million) upfront and up to 1.05 billion euros contingent on achievements. CureVac said it would cut about 30 per cent of its jobs as it focuses on mRNA-based cancer therapies and other earlier-stage projects. It added GSK’s cash payment extends funding, which would have run out at the end of next year, into 2028. Under the partnership that began in 2020 during the COVID-19 pandemic, the companies have worked together to develop mRNA vaccines for infectious diseases. Wednesday’s agreement reflects GSK CEO Emma Walmsley’s focus on ...
- Source: drugdu
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- July 6, 2024
Submission of Nidlegy marketing authorisation application validated by EMA

Philogen and Sun Pharmaceutical Industries (“Sun Pharma”) announces that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorisation Application (MAA) for Nidlegy , which was finalised on June 3 2024. “The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, chief executive officer and chief scientific officer at Philogen. “Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need.” Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024. https://sunpharma.com/wp-content/uploads/2024/07/Press-Release-Validation-of-Nidlegy%E2%84%A2-Marketing-Authorization-Application-Submission-by-EMA.pdf
- Source: drugdu
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- July 6, 2024
FDA approves Eli Lilly’s alzheimer’s drug

The U.S. Food and Drug Administration has approved Eli Lilly’s Kisunla (donanemab-azbt) injection, a new treatment for Alzheimer’s disease. Targeted at adults in the mild cognitive impairment or mild dementia stage, Kisunla has shown significant promise in slowing clinical decline, offering a new beacon of hope for patients and their families. The approval comes after a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) in patients with Alzheimer’s disease. The patients had confirmed the presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. 1736 patients were randomised 1:1 to receive 700 mg Kisunla every four weeks for the first 3 doses, and then 1400 mg every four weeks (N = 860) or placebo (N = 876) for a total of up to 72 weeks. The treatment was switched to placebo based on a prespecified reduction in amyloid levels measured by positron emission tomography (PET) at Week ...
- Source: drugdu
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- July 6, 2024
GSK Pays CureVac €400M to Pick Up Clinical-Stage mRNA Vaccines for Infectious Diseases

GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company. By Frank VinluanGSK and CureVac forged their relationship during the Covid-19 pandemic, setting out to develop vaccines that could protect against the novel coronavirus and other infectious diseases. The collaboration has advanced two vaccine candidates into clinical testing, and now GSK is taking over both, one of them in development for an infectious disease target that’s particularly hot right now. Under terms of the restructured agreement announced Wednesday, GSK will now have full control of developing and manufacturing the avian influenza vaccine, currently in Phase 1 testing, and a Covid-19 vaccine in Phase 2 testing. GSK is paying €400 million (about $431.4 million) up front to obtain global rights ...
- Source: drugdu
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- July 5, 2024
Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines

By Don Tracy, Associate Editor Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus. The Biomedical Advanced Research and Development Authority (BARDA) has granted Moderna a $176 million project award under the Rapid Response Partnership Vehicle (RRPV) Consortium, with the goal of expediting the development of mRNA-based pandemic influenza vaccines. Reportedly, the award is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus, a subtype known for causing severe avian influenza and posing a potential risk to humans.1 “mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” said Stéphane Bancel, CEO, Moderna, in a press release. “We are pleased to continue our collaboration with BARDA to ...
- Source: drugdu
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- July 5, 2024
Liver Biopsy Reveals Early Signs of Rapid Metastasis in Pancreatic Cancer Patients

Only 10% of individuals diagnosed with pancreatic cancer will live beyond two years post-diagnosis. The ability to predict the timing and location of metastases could dramatically transform the treatment approach for pancreatic cancer, especially for those at high risk of metastasis. Now, researchers have employed liver biopsies—a small tissue sample taken for laboratory analysis—to identify cellular and molecular markers that might predict if and when pancreatic cancer will metastasize to the liver or other areas like the lungs. A study conducted by Weill Cornell Medicine (New York, NY, USA) and an international research group suggests that data from liver biopsies obtained at the time of pancreatic cancer diagnosis could inform personalized treatment plans, such as liver-targeted immunotherapies, to preempt the spread of cancer cells. The research team discovered in 2015 that pancreatic cancer cells emit substances that primarily target the liver to create a pre-metastatic niche that promotes the growth ...
- Source: drugdu
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- July 5, 2024
New Lab Test Detects Persistent HIV Strains in Africa

Most research on the human immunodeficiency virus (HIV) has concentrated on the virus variants prevalent in Western nations, primarily impacting men who have sex with men, with a focus on subtype B. However, less attention has been given to the variants in Africa, where the virus significantly affects women. To develop a universally effective cure, it’s crucial to investigate viral variants not only in developed regions but across different global demographics. Researchers have now developed a test to measure HIV persistence in individuals predominantly affected by African viral strains—a critical step towards finding a cure that can aid patients globally. This research, published in Nature Communications on July 2, addresses a significant shortfall in HIV research. The findings of the study by a multinational team led by investigators at Weill Cornell Medicine (New York, NY, USA)—similar to findings in the developed world—revealed that African HIV strains form viral reservoirs in ...
- Source: drugdu
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- July 5, 2024

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