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Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline

Don Tracy, Associate Editor Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers. Novartis announced that it has acquired Mariana Oncology, a biotech specializing in developing radioligand therapies (RLTs) for cancer treatment. According to the company, the acquisition is expected to enhance Novartis’ existing RLT pipeline and add major research capabilities. These programs target breast, prostate, and lung cancers, and features a leading developmental candidate, MC-339, for small cell lung cancer. As per terms of the agreement, Novartis is expected to make an upfront payment of $1 billion, with further potential payments of up to $750 million upon the completion of pre-specified milestones.1 “The acquisition of Mariana Oncology reflects our commitment to radioligand therapy as one of our company’s key technology platforms and strengthens our leadership in this field,” said Fiona Marshall, president, biomedical research, Novartis, in a press release. “We are ...
- Source: drugdu
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- May 6, 2024
【EXPERT Q&A】What is CAPA for Medical Devices?

Drugdu.com expert’s response: Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include: 1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes. 2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training. CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
- Source: drugdu
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- May 6, 2024
Lupin Digital Health’s Lyfe Platform gets Class C Medical Device License from CDSCO

Lupin Digital Health’s Lyfe platform has received approval as a Class C Medical Device from the Central Drugs Standard Control Organisation (CDSCO). A press statement informed that Lyfe is now India’s first clinically proven remote cardiac rehabilitation program, designed to enhance heart health and quality of life. By providing tailored, accessible solutions in the comfort of patients’ homes, Lyfe empowers individuals to confidently manage their heart health. Rajeev Sibal, President – India Region Formulations, Lupin, stated, “This approval reaffirms our dedication to excellence in cardiac care. We are proud to be at the forefront of digital therapeutics in India, signifying our commitment to supporting cardiologists with patient-centric solutions and improving cardiovascular outcomes.” Elaborating on the significance of receiving this license, Sidharth Srinivasan, CEO, Lupin Digital Health added, “Securing the Class C Medical Device license for Lyfe is a significant achievement. It validates Lyfe as a best-in-class platform to support millions ...
- Source: drugdu
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- May 5, 2024
BigHat Biosciences partners with Janssen Biotech

Strategic collaboration to leverage BigHat’s AI/ML (Artificial Intelligence / Machine Learning) guided Milliner platform to design high-quality next-generation protein therapeutics BigHat Biosciences, a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform announced a collaboration with Janssen Biotech Inc., a Johnson & Johnson company. This strategic collaboration combines the drug discovery, clinical development and data science expertise from Johnson & Johnson with BigHat’s Milliner platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high-quality antibodies for multiple Neuroscience therapeutic targets. The agreement was facilitated by Johnson & Johnson Innovation. BigHat’s antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with machine learning technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins ...
- Source: drugdu
- 117
- May 5, 2024
Abbott Earns FDA Approval For Dissolving Stent That Unclogs Arteries Below The Knee

Abbott earned a groundbreaking FDA approval on Monday for its dissolving stent designed to unclog arteries below the knee. The device, called the Esprit BTK System, is meant to treat patients who have chronic limb-threatening ischemia below the knee. This condition is characterized by insufficient blood flow to the lower extremities, which leads to persistent pain, ulcers and tissue necrosis — with a significant risk of limb amputation if left untreated Chronic limb-threatening ischemia below the knee may be the most severe form of peripheral artery disease, said Jennifer Jones-McMeans, divisional vice president of global clinical affairs at Abbott’s vascular business. “This is really a landmark moment,” she said in an interview. “We’re looking at the first dissolving stent to treat below-the-knee arterial disease. And really, when you look at this severe form of upper artery disease, it’s considered kind of the terminal end of this disease — meaning that these patients have ...
- Source: drugdu
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- May 5, 2024
UK sets out position on regulating AI as a medical device

Dive Brief A U.K. agency outlined its position on the regulation of artificial intelligence as a medical device in a policy paper published Tuesday.The Medicines and Healthcare products Regulatory Agency (MHRA) said many AI products that can be put on the market now without conformity assessment will move to a higher risk category in upcoming reforms.The paper explains how MHRA interprets a government AI strategy focused on principles such as safety, security and robustness and aligns it with international standards. Dive Insight The U.K. government committed to five cross-sector principles for the regulation of AI in February. A consultation found “strong support” for the principles, the government said, and established them as the basis for a regulatory framework designed to keep pace with rapidly advancing AI technology. Days later, the government wrote to the MHRA to request details of its approach to AI. In response, the MHRA published a policy ...
- Source: drugdu
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- May 5, 2024
Exploring molecular landscapes of cancer in Hispanic/Latin American patients

A new editorial paper was published in Oncoscience (Volume 11) on April 22, 2024, entitled, “Exploring oncogenic driver molecular alterations in Hispanic/Latin American cancer patients: A call for enhanced molecular understanding.” In this new editorial, researcher Rafael Parra-Medina from Fundación Universitaria de Ciencias de la Salud and Instituto Nacional de Cancerología begins by discussing Latin America’s (LA) population -; a heterogeneous mix of Amerindian, African, and Caucasian ancestries with different proportions in different regions. Countries such as Argentina, Brazil, Colombia, Costa Rica, Uruguay, and Venezuela have a higher proportion of Caucasian while regions in Mexico, Perú, and Bolivia have a higher proportion of Amerindian ancestries. Although the overall incidence of cancer in Latin American countries is generally lower compared to high-income nations, the mortality rate is notably higher. “This disparity can be attributed to several factors, including smoking habits, diet quality, levels of physical activity, access to healthcare services, and ...
- Source: drugdu
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- May 5, 2024
Patient Rights Advocate Files Amicus Brief in Lawsuit Against Blue Cross Blue Shield of Minnesota

The fight over affordable drug prices continues. PatientRightsAdvocate.org announced that it has filed an amicus brief in the Department of Labor’s (DOL) case against Blue Cross Blue Shield of Minnesota.1 Acting secretary of labor Julie A. Su filed the case in January of this year, claiming that Blue Cross collected about $66.8 million for provider taxes from 370 self-funded employer health plans. Provider taxes vary from state to state, but they are typically paid by hospitals and clinics. These funds can be used as a source of funding for Medicaid, provided they meet certain requirements. In the lawsuit,2 the DOL of writes, “BCBSM, Inc. has for years unilaterally caused the self-funded health benefit plans for which it serves as third-party administrator to compensate BCBSM, Inc.’s in-network providers for amounts they owe under a Minnesota provider tax—amounts the providers never billed or passed on to the plans—without authority to do so under the ...
- Source: drugdu
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- May 5, 2024
Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower ...
- Source: drugdu
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- May 5, 2024
PharmaLink partners with Recall Results on safety of drugs

PharmaLink has partnered with Recall Results on an accurate and responsive process for drug recalls, withdrawals and market actions in the pharmaceutical industry. The collaboration combines PharmaLink’s pharmaceutical returns processing expertise with Recall Results’ knowledge and advanced technologies for managing complex recalls.It will focus on the development of integrated systems to streamline the process of recalls, supporting recalls of any class to the patient level. It aims to cut down the time to identify and respond to potentially harmful pharma products in the market.With a focus on patient safety and compliance, the two companies are set to establish new standards in recall management. PharmaLink CEO Thierry Beckers stated: “Through this partnership, PharmaLink offers comprehensive services for the notification, product retrieval, processing, storage and disposal of recalled products from the healthcare supply chain.“We could not be more excited about the launch of this strategic partnership and the solutions it brings to ...
- Source: drugdu
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- May 5, 2024

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