Pharmaceutical Technology
AUGUST 19, 2024
The partners will conduct a study using blood samples and joint biopsies from various patient subgroups, focusing on those resistant to current treatments.
Bio Pharma Dive
AUGUST 19, 2024
A new wave of antipsychotics could improve patient adherence. The race to corner this large projected market is already getting tight.
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Pharmaceutical Technology
AUGUST 19, 2024
Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 19, 2024
The progress of a human being through life might be thought of as a mostly gradual succession of changes from the ovum to the grave. But if you wake up one morning, look in the mirror, and wonder when you suddenly grew so much older, you may not be imagining things.
Pharmaceutical Technology
AUGUST 19, 2024
Cyril Ramaphosa, the president of South Africa, has asked the WHO to ensure African countries have equitable access to mpox vaccines.
Bio Pharma Dive
AUGUST 19, 2024
The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 19, 2024
The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.
Bio Pharma Dive
AUGUST 19, 2024
Partner MediLink Therapeutics is limiting the drug’s dosing after reports of lowered white blood cell counts and inflammation of the digestive tract.
Pharmaceutical Technology
AUGUST 19, 2024
PT217 has received orphan drug designations from the FDA for the treatment of neuroendocrine carcinoma in addition to small cell lung cancer.
pharmaphorum
AUGUST 19, 2024
Walgreens has signed a $100m contract with the US government's BARDA agency for access to its decentralised clinical trials network
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
AUGUST 19, 2024
Daiichi Sankyo and AstraZeneca's ENHERTU has received FDA BTD status for the treatment of specific types of metastatic breast cancer.
Fierce Pharma
AUGUST 19, 2024
Liquidia and its dry powder Yutrepia is back in FDA limbo after the agency opted for a tentative approval as opposed to a standard nod. | The agency granted a broad regulatory exclusivity to rival United Therapeutics and its Tyvasvo DPI, leaving Liquidia's Yutrepia, which uses the same active drug, in FDA limbo until 2025.
Pharmaceutical Technology
AUGUST 19, 2024
Immuron Limited has won a $2.3m grant to develop a version of its anti-diarrhoeal medication Travelan, following support from the US DoD.
Pharma Times
AUGUST 19, 2024
In the UK study, researchers analysed 2,023 bowel cancers from the 100,000 Genomes Project
Pharmaceutical Technology
AUGUST 19, 2024
SciSparc has signed an exclusive patent license agreement with Polyrizon to out-license its SCI-160 programme for pain treatment.
Fierce Pharma
AUGUST 19, 2024
Industry watchers largely breathed a sigh of relief last week after the Medicare price cuts for certain costly drugs under the Inflation Reduction Act initially appeared better than expected. | The magnitude of price cuts under the Inflation Reduction Act initially appeared better than expected. However, that rosy view may have missed an important point, one analyst team contends.
Pharmaceutical Technology
AUGUST 19, 2024
According to GlobalData, annual biologic approvals outnumbering small molecules approvals is set to become a longstanding trend.
Pharma Times
AUGUST 19, 2024
The contract concerns profiling Immunoglobulin E autoantibodies in blood serum
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharmaceutical Technology
AUGUST 19, 2024
Gilead Sciences has partnered with PANTHERx Rare to distribute LIVDELZI, a primary biliary cholangitis (PBC) treatment.
Fierce Pharma
AUGUST 19, 2024
With its rapid development of the Jynneos vaccine, Bavarian | After the WHO declared mpox a global health emergency for the second time in 25 months, Bavarian Nordic said it could ramp up manufacturing to supply 12 million doses of its Jynneos vaccine through 2025 to contain the virus in Africa.
pharmaphorum
AUGUST 19, 2024
Pfizer and BioNTech have a phase 3 mishap with their combined COVID-19 and influenza vaccine, handing Moderna an advantage
Fierce Pharma
AUGUST 19, 2024
Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.” | Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
pharmaphorum
AUGUST 19, 2024
The EMA has started a review of AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) that could see the drug being used in advanced breast cancer with even lower levels of the HER2 biomarker.
Drug Discovery World
AUGUST 19, 2024
The discovery of a new regulator affecting immune cells could lead to new treatments to reduce inflammation in diseases including arthritis and severe Covid-19. A large research collaboration, led by the University of Exeter’s MRC Centre for Medical Mycology, has focused on how immune cells sense their environment. This activity triggers responses which are finely balanced, to protect against disease and infection, and to reduce cell-damaging inflammation.
pharmaphorum
AUGUST 19, 2024
Safeguarding patient data is crucial in the healthcare industry. This article outlines four steps to consider when assessing your IT infrastructure to protect against ransomware and ensure the security of patient data.
Drug Discovery World
AUGUST 19, 2024
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The chosen news highlights this week all feature advances in drug development in oncology indications and reflect the breadth of therapeutic approaches to cancer treatment.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
XTalks
AUGUST 19, 2024
The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Effective collaboration between these teams can lead to smoother project execution and, ultimately, better outcomes for patients. However, achieving this level of coordination requires a deliberate and strategic approach grounded in transparency and mutual trust.
Drug Discovery World
AUGUST 19, 2024
CV6 Therapeutics has initiated patient dosing in Phase Ia clinical trial evaluating its investigational first-in-class, specific dUTPase inhibitor CV6-168 + infusional 5-fluorouracil (5-FU). The study will assess the safety, pharmacokinetic and pharmacodynamic profiles and anti-tumour activity for CV6-168 in the treatment of patients with advanced metastatic solid tumours refractory to standard treatment, including colon, gastric, breast, ovarian, lung, and other solid tumours.
Drug Patent Watch
AUGUST 19, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
Drug Discovery World
AUGUST 19, 2024
Researchers have uncovered how Flaviviruses like Dengue and Zika propagate, suggesting the possibility of new treatment strategies. They have identified a transporter protein, called importin-7 (IPO7), as crucial for the nuclear transport of Flaviviridae core proteins. Viruses of the family Flaviviridae, including Japanese encephalitis virus (JEV), Dengue virus (DENV), Zika virus (ZIKV), West Nile virus (WNV), and Tick-borne encephalitis virus, are known to cause severe diseases.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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