EMA approves Bayer’s NTRK-targetting Vitrakvi for children and adults

Pharmaceutical Technology | September 24, 2019

Bayer has announced that the European Medicine Agency (EMA) has licensed its Vitrakvi (larotrectinib) in adults and children with solid tumours displaying Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The indicated patients must also have either locally advanced or metastatic disease, or be in a situation where there are no adequate treatment options or surgical resection is likely to cause severe morbidity. This makes Vitrakvi the first tumour agnostic drug to be approved in the European Union (EU), which means it can be used against multiple tumour types with the same, rare genetic alteration. NTRK gene fusion occurs when the NTRK gene fuses with an unrelated gene, leading to an altered TRK protein, which has oncogenic drivers encouraging the spread and growth of cancer cells.

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Leading Australian medicinal cannabis exporter, Little Green Pharma continues to expand making significant strides in lucrative global markets

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Leading Australian medicinal cannabis exporter, Little Green Pharma continues to expand making significant strides in lucrative global markets

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Horus Pharma and Plastic Bank Collaborate to Recycle Nearly 100 Tons of Plastic

Horus Pharma | January 11, 2023

On January 10, 2023, Horus Pharma, an independent French ophthalmology laboratory known for its preservative-free eye and eyelid health products, announced a partnership with Plastic Bank to recycle approximately 100 tons of plastic annually. The pact is a part of Horus Pharma's environmental program, Eco' Ophtalmo. Since its founding in 2003, corporate social responsibility (CSR) has been a consistent part of Horus Pharma's culture. Over the years, the company's increasing awareness of industrial activities' environmental impact has led to numerous initiatives. Horus Pharma has committed to continuously seeking new solutions via innovation and collaboration to minimize its ecological footprint to the greatest extent possible. Furthermore, through its strategy of cooperative actions and initiatives, it strives to encourage and support the spread of ecologically-responsible practices within its industry. Launched in September 2022, the Eco' Ophtalmo initiative has incorporated ecology into Horus Pharma's culture and strategy planning. Eco' Ophtalmo project encompasses major and ambitious initiatives, including an environmental and social commitment to achieve Plastic Net Zero and create recyclable packaging. In addition, Horus Pharma aims to promote awareness among ophthalmologists and drive action by cooperating to increase awareness and encourage collective efforts to reduce the environmental footprint. About Horus Pharma Founded in 2003, Horus Pharma is a leading eye and eyelid health product developer. It operates in most ophthalmology segments to develop effective and safe practical innovations. Focused on patient safety, its laboratories are renowned for their expertise in developing preservative-free formulations and product delivery systems. The laboratory's product portfolio includes medicinal products, food supplements, and medical devices. In addition, it has been pursuing growth with its new surgery division by providing surgical and peri-surgical diagnostic solutions for eye problems.

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EU Approves Zynlonta for Relapsed or Refractory Diffuse Large B-cell Lymphoma

ADC Therapeutics | January 03, 2023

Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September. Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer. The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL. Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs. ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein. According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics. About ADC Therapeutics ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.

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Northstar and Inhibrx Join Hands to Develop Radiopharmaceutical Candidates

Northstar and Inhibrx | January 09, 2023

NorthStar Medical Radioisotopes, LLC, announced a collaboration with Inhibrx, Inc., to develop and produce new radiopharmaceuticals for cancer treatment. Inhibrx will develop a new generation of targeted alpha treatments utilizing its improved single-domain antibodies (sdAbs). With a long history of sdAb innovation, it has created a library of sdAbs targeting tumor-associated antigens. Its high binding affinity and specificity for tumor cells or antigen-expressing cells within the tumor microenvironment make sdAbs an ideal biological targeting agent for radioisotope delivery. In addition, alpha-emitting radioisotopes have a small range of activity and high energy transfer, allowing for the targeted destruction of cancer cells with minimum damage to adjacent healthy tissue. NorthStar is expanding its position as an industry leader in the rapidly-growing field of therapeutic radioisotopes, and it is now prepared to become the first commercial-scale manufacturer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67). Under the terms of this agreement, NorthStar will provide the supply of Ac-225 and access to its comprehensive radiopharmaceutical contract development and manufacturing organization (CDMO) services to assist the development of a predetermined number of Inhibrx's novel biologic medicines. NorthStar will also prepare Inhibrx patient dosages for clinical studies and, upon approval, may manufacture and supply radionuclides for its commercial use. About NorthStar Medical Radioisotopes, LLC NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company with a mission to provide patients with global access to game-changing radiopharmaceuticals. The company uses ecologically preferable technologies to create, manufacture, and distribute diagnostic imaging and therapeutic radiopharmaceuticals. It is the only commercial U.S. producer of molybdenum-99, an essential diagnostic imaging radioisotope (Mo-99). The FDA-approved RadioGenix® System (technetium Tc 99m generator) uses US-manufactured, non-uranium-based Mo-99 as the source material to generate technetium-99m (Tc-99m), which is used to assess heart disease and cancer.

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