Search Results for “EU” – Page 21 – media

Capital Rx, Prime Therapeutics Form Strategic Alliance

Pharmacy solutions and pharmacy benefit managers perform several functions, including administrative tasks, handling benefit processing claims and negotiating with the supply chain. However, the problem is that many of them are performing these tasks on outdated technology. “All of those things, to do them well, require a foundation of technology capabilities to enable our people to operate at the top of their license. … The majority of the industry is using 30 to 40-year-old technology to do all of this work,” said Mostafa Kamal, president and CEO of pharmacy benefit manager Prime Therapeutics, in an interview. That’s why Prime Therapeutics has formed a strategic alliance with Capital Rx, which is also a PBM, the companies announced last week. Through the alliance, Prime Therapeutics will be the only PBM — aside from Capital Rx — to use Capital Rx’s JUDI platform. JUDI is a pharmacy benefits administration platform that puts all ...
- Source: drugdu
- 122
- March 25, 2024
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections, including neutropenic sepsis—a potentially fatal reaction to infection and a severe complication of chemotherapy. Identifying the signs of neutropenic sepsis can be challenging, leading to a stressful and expensive treatment process. Consequently, all chemotherapy patients feeling ill are advised to seek emergency care to check for neutropenic sepsis. Unfortunately, half of these patients do not receive antibiotics quickly enough, while the other half, not at risk of neutropenic sepsis, unnecessarily visit the emergency department. 52North Health Ltd. (Cambridge UK) has developed NeutroCheck, a groundbreaking approach aimed at enhancing the safety and well-being of cancer patients. This innovation combines a finger-prick blood test with an AI-powered digital platform, allowing patients to evaluate their neutropenic sepsis risk at home. This affordable, ...
- Source: drugdu
- 96
- March 22, 2024
New study reveals neurological conditions as leading cause of ill health worldwide

In 2021, neurological conditions, including Alzheimer’s disease, affected approximately 3.4 billion people globally In a new study funded by the Bill & Melinda Gates Foundation, results published in the Lancet Neurology have determined that neurological conditions are currently the leading cause of ill health worldwide. Results showed that the biggest contributors to neurological health loss globally were stroke, neonatal encephalopathy, migraine, Alzheimer’s disease and other dementias, and diabetic neuropathy. Affecting 3.4 billion people globally in 2021, neurological conditions are any conditions that affect the brain, spinal cord and nerves, which can affect anyone at any age. The study revealed that the number of people globally living with or dying from neurological conditions has drastically risen in the past three decades, partially due to ageing societies. Worldwide, the analysis suggests that the total amount of disability, illness and premature death caused by neurological conditions increased by 18% between 1990 and 2021. ...
- Source: drugdu
- 127
- March 22, 2024
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU

The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run. During the first meeting of the MSP advisory group that officially kicks-off the platform, María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, said: “The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe.” The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by ...
- Source: drugdu
- 112
- March 22, 2024
FDA Grants Accelerated Approval to Takeda’s Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
- Source: drugdu
- 162
- March 21, 2024
With MS & Fibrosis Trials Planned, J&J-Partnered Contineum Now Preps for IPO

Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression. By FRANK VINLUAN Jhnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the ...
- Source: drugdu
- 101
- March 20, 2024
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystroph

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” said Peter Marks, M.D., Ph.D., director of ...
- Source: drugdu
- 151
- March 20, 2024
Biotheus Expanded Their Partnership with Hansoh Pharma for Developing EGFR/cMET Bispecific Antibody-Drug Conjugates

ZHUHAI, China, March 15, 2024 /PRNewswire/ — On March 14, 2024, Biotheus Inc. (Biotheus), a clinical-stage biotech company focusing on the discovery and development of biologics for oncology and inflammatory diseases, and Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma,03692.HK), China’s leading innovation-driven pharmaceutical company, jointly announced that the two parties will further expand their strategic collaboration, following their current partnership since 2022. Biotheus will grant Hansoh Pharma a license to use the proprietary anti-EGFR/cMet bispecific antibody PM1080/HS-20117 independently developed by Biotheus for the development of antibody-drug conjugates products (ADC Product). Under the terms of the agreement, Hansoh Pharma will obtain exclusive worldwide rights from Biotheus to use PM1080/HS-20117 for the development, production, and commercialization of ADC Product, with the right of sublicense. Biotheus will be eligible to receive up to 5 billion RMB in upfront and success-based milestones for ADC Product, as well as tiered royalties based on global net ...
- Source: drugdu
- 173
- March 19, 2024
Hengrui Pharmaceuticals Clinical Trial Approved for Novel PARP Inhibitor HRS-1167 (M9466) Combination Therapy for Advanced Solid Tumors

Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
- Source: drugdu
- 175
- March 18, 2024
New Study Finds Direct-to-Consumer Pharmaceutical Advertising Can Benefit Public Health Goals When Incentives Align

Don Tracy, Associate Editor Data shows that from 2014-2019, pneumococcal vaccinations in seniors increased by 10%, growing sales for Prevnar 13 due to government recommendation in addition to a high-profile advertising campaign.A 2014 recommendation by the Advisory Committee on Immunization Practices (ACIP) for adults aged 65 years and over to receive Prevnar 13 was followed by Pfizer initiating a high-profile advertisement campaign for the vaccinations. During this time, Medicare and private insurance companies began covering the vaccine as well. According to a new study published in the Journal of Policy Analysis and Management, over the next five years, this resulted in a 10% increase in vaccination among seniors and a corresponding $1 billion annual increase in Prevnar 13 sales. According to the authors of the study, government vaccine recommendations may offer substantial value to pharmaceutical manufacturers, further implying that direct-to-consumer (DTC) advertising can lead to successfully achieving public health goals ...
- Source: drugdu
- 208
- March 16, 2024

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