U.S. states build stockpiles of malaria drug touted by Trump

Abcnews | April 26, 2020

State and local governments across the United States have obtained about 30 million doses of a malaria drug touted by President Trump to treat patients with the coronavirus, despite warnings from doctors that more research is needed. At least 22 states and Washington, D.C., secured shipments of the drug, hydroxychloroquine, according to information compiled from state and federal officials by The Associated Press. Sixteen of those states were won by Trump in 2016, although five of them, including North Carolina and Louisiana, are now led by Democratic governors. Supporters say having a supply on hand makes sense in case the drug is shown to be effective against the pandemic that has devastated the global economy and killed nearly 200,000 people worldwide, and to ensure a steady supply for people who need it for other conditions like lupus. But health experts worry that having the drug easily available at a time of heightened public fear could make it easier to misuse it. The U.S. Food and Drug Administration on Friday warned doctors against prescribing the drug, hydroxychloroquine, for treating the coronavirus outside of hospitals or research settings because of reports of serious side effects, including dangerous irregular heart rhythms and death among patients.

Spotlight

Inspired by the body’s approach to breaking down alcohol, we chose three natural enzymes that convert alcohol into harmless molecules that are then excreted. That might sound simple because these enzymes were not new, but the tricky part was to figure out a safe, effective way to deliver them to the liver.

Spotlight

Inspired by the body’s approach to breaking down alcohol, we chose three natural enzymes that convert alcohol into harmless molecules that are then excreted. That might sound simple because these enzymes were not new, but the tricky part was to figure out a safe, effective way to deliver them to the liver.

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BUSINESS INSIGHTS

Dicerna Announces Expiration of Hart-Scott-Rodino Act Waiting Period for Novo Nordisk Tender Offer to Acquire Dicerna

Dicerna Pharmaceuticals, Inc. | December 27, 2021

Dicerna Pharmaceuticals, Inc. announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended in connection with Novo Nordisk’s cash tender offer for Dicerna expired at 11:59 p.m., Eastern Time, on December 24, 2021. As previously announced on November 18, 2021, Novo Nordisk commenced a cash tender offer to purchase all outstanding shares of Dicerna common stock for $38.25 per share in cash, without interest and subject to any withholding of taxes. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Other conditions remain to be satisfied, including, among others, a minimum tender of shares representing one more share than 50% of the sum of the total number of Dicerna shares outstanding at the time of the expiration of the offer. Unless the tender offer is extended, the offer and withdrawal rights will expire at 5:00 p.m., Eastern Time, on December 27, 2021. About Dicerna Dicerna Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference to silence selectively genes that cause or contribute to disease. Using our proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on disease-causing genes in the liver, Dicerna has continued to innovate and is exploring new applications of its RNAi technology with GalXC-Plus, which expands on the functionality and application of our flagship liver-targeted GalXC technology to tissues and cell types outside the liver, and has the potential to treat diseases across multiple therapeutic areas. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc.

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PHARMACY MARKET

Fusion Pharmaceuticals and TRIUMF Announce Expanded R&D Collaboration for Actinium Supply Production

Fusion Pharmaceuticals Inc. | August 13, 2021

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and TRIUMF, Canada's particle accelerator centre, today announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225. Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope. "As we advance our growing pipeline of actinium-based targeted alpha therapies (TATs), we are focused on expanding our manufacturing capabilities and continuing to proactively address and prioritize actinium supply. This supports our strategic plans to develop differentiated radiopharmaceuticals to treat a broad range of cancers with high unmet medical need," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are excited to expand our collaborative relationship with TRIUMF, a leader in isotope production, marking an important step to further expand actinium-225 production and supply." "Through its TAT platform technology, Fusion has the opportunity to unlock the full potential of actinium, an alpha-emitting isotope with the ability to deliver a potent, highly localized payload to cancer cells, " said TRIUMF Innovations CEO, Kathryn Hayashi. "With this next phase, we are solidifying our partnership with a premier developer of innovative actinium radiopharmaceuticals to deepen TRIUMF's leadership position in isotope production and impact the cancer treatment landscape." TRIUMF Director and CEO, Nigel Smith, Ph.D. added, "This marks an important milestone in the existing collaboration between Fusion and TRIUMF. Our partnership is generating new ideas and innovations that validate the important role TRIUMF has at the forefront of the global medical isotope ecosystem. Together TRIUMF and Fusion are laying the groundwork for major breakthroughs that will benefit the lives of countless patients around the world." In December 2020, Fusion and TRIUMF entered a collaboration and supply agreement to develop, produce and procure the supply of actinium-225 to Fusion. As part of this agreement, Fusion will continue its investment of up to $25 million (CAD) in TRIUMF to advance technology and processes for actinium-225 production. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3); and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion recently entered into an agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. About TRIUMF TRIUMF is Canada's particle accelerator centre. The lab is a hub for discovery and innovation, inspired by a half-century of ingenuity in answering some of nature's most challenging questions. From the hunt for the smallest particles in the universe to the development of new technologies, TRIUMF is pushing frontiers in research, while training the next generation of leaders in science, medicine, and industry.

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PHARMACY MARKET

Treosulfan, a First-In-Class Conditioning Agent, is Licensed in Canada by Medexus Pharmaceuticals and Medac GmbH

Medexus Pharmaceuticals | July 13, 2021

Medexus Pharmaceuticals Inc. announced today that it has entered into a licensing deal with medac GmbH to commercialize treosulfan, a bifunctional alkylating agent, in Canada. Treosulfan will be sold in Canada as Trecondyv and will be used in conjunction with fludarabine as part of a conditioning regime before allogeneic hematopoietic stem cell transplantation. Medexus will be in charge of selling and promoting the product, while Medac will manufacture and supply it. Medexus has been distributing treosulfan in Canada through the Special Access Program, and Health Canada recently approved Trecondyv for the treatment of adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes who are at increased risk for standard conditioning therapies, as well as pediatric patients older than one year with AML or MDS. About medac GmbH medac GmbH is a privately owned global pharmaceutical firm that is expanding its pharmaceutical and diagnostics businesses. Since its inception in Germany in 1970, medac has specialized in treating diseases related to oncology, hematology, urology, and auto-immune disorders. medac is dedicated to improving current therapeutic products and creating new ones to enhance patients' quality of life. In addition, medac has earned a reputation for developing novel medicines in less common indications. This dedication has resulted in a diverse range of pharmaceutical goods that positively impact the lives of patients. medac is constantly investing in product development and manufacturing and logistical capacities to fulfill the requirements of both patients and healthcare professionals. About Medexus Medexus is a market leader in novel rare disease treatment solutions, with a solid commercial platform in North America. We are building a highly distinctive business with a portfolio of innovative and high-value orphan and rare disease medicines that will support our growth for the next decade, based on a foundation of proven best-in-class medications. Through our key principles of Quality, Innovation, Customer Service, and Teamwork, the Company's goal is to offer the finest healthcare products to healthcare professionals and patients. Medexus Pharmaceuticals specializes in the treatment of auto-immune illness, hematological, and allergies. Rasuvo and Metoject, a unique methotrexate formulation (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor

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