Antibody suppresses HIV for four months

Pharmaphorum | April 18, 2019

Antibody suppresses HIV for four months
A new antibody has shown potential as treatment for HIV with a mid-stage trial showing it suppressed the virus for up to four months after patients stopped taking antiretroviral medicines. Developed by Taiwan’s United Bio Pharma and one of the US government-funded National Institutes of Health, the phase 2 study showed UB-421 was safe and did not induce production of antibody resistant HIV. The study was supported in part by the US National Institute of Allergy and Infectious Diseases, and results were published in The New England of Medicine. Conducted in Taiwan and led by United Bio Pharma’s chief scientific officer Chang Yi Wang, the study involved the 29 volunteers discontinuing their antiretroviral (ART) therapy at the time of their first infusion or a week later depending on their regimen. Fourteen study participants received weekly injections of UB-421 over eight weeks while 15 received a higher dose biweekly for 16 weeks. At the end of the eight- or 16-week treatment period, all volunteers restarted their previous ART regimen and were evaluated in follow-up visits up to eight weeks later. Apart from a single participant who discontinued the study because of a mild skin rash, volunteers in both groups-maintained HIV suppression (plasma HIV RNA levels under 20 copies/mL) throughout the treatment period in the absence of ART. Including previous phase 1 and phase 2 studies, a total of 78 patients received the UB-421 treatment.

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TriMas Announces Two New Acquisitions

TriMas | December 14, 2021

TriMas announced that it has recently signed agreements to acquire Omega Plastics to be added to TriMas Packaging, and TFI Aerospace to be added to TriMas Aerospace. Omega, located in Clinton Township, Michigan, specializes in manufacturing custom components and devices for drug delivery, diagnostic and orthopedic medical applications, as well as components for industrial applications. Omega leverages its advanced in-house tool making capabilities, ISO13485-certified injection molding facility and ISO Class 8 clean room to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega is an approved vendor to several leading medical device companies, with a long track record of unparalleled service and quality. Omega currently operates as a private, family-owned company, and is expected to generate approximately $18 million in revenue in fiscal year 2021. “We are excited to announce the agreement between TriMas and Omega. We look forward to expanding Omega’s production capacity to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add rapid prototyping to enhance TriMas Packaging’s speed-to-market advantage on innovation and new product designs. The addition of Omega further expands our Pharmaceutical & Nutraceutical product offerings into additional medical applications, which we believe is an attractive market for long-term growth.” Thomas Amato, President and Chief Executive Officer of TriMas Located near Toronto, Canada, TFI is a leading manufacturer and supplier of specialty fasteners used in a variety of applications, predominantly for the aerospace end market. TFI currently operates as a private, family-owned company, and is expected to generate approximately $6 million in revenue in fiscal year 2021. “In addition to expanding TriMas Packaging through the acquisition of Omega, we are also pleased to announce the acquisition of TFI,” Amato continued. “This acquisition will further expand TriMas Aerospace’s fastener product lines with the addition of complimentary niche products that have an exciting growth trajectory resulting from TFI’s new program wins and the overall aerospace market recovery. We anticipate TFI’s customers will benefit from the added innovation and manufacturing depth offered by TriMas Aerospace, while TriMas Aerospace’s customers will enjoy additional product offerings.” Amato continued, “We continue to execute on our core strategy of augmenting our growth through bolt-on acquisitions by leveraging our strong cash generation. After closing these two acquisitions, we expect our net leverage ratio to remain below 2.0x, providing ample capacity to execute on additional bolt-on acquisitions while also returning capital to shareholders through dividends and share buybacks.” TriMas expects to close on Omega by the end of the year, and closed on TFI simultaneously with signing. “We look forward to welcoming both Omega and TFI to the TriMas family of businesses,” concluded Amato. About TriMas TriMas is a global manufacturer and provider of products for customers primarily in the consumer products, aerospace and industrial markets, with approximately 3,300 dedicated employees in 11 countries. We provide customers with a wide range of innovative and quality product solutions through our market-leading businesses. Our TriMas family of businesses has strong brand names in the markets served, and operates under a common set of values and strategic priorities under the TriMas Business Model. TriMas is publicly traded on the NASDAQ under the ticker symbol “TRS,” and is headquartered in Bloomfield Hills, Michigan.

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PHARMACY MARKET

Sanofi's hopes for rare blood disease candidate sutimlimab on hold after FDA blasts 3rd-party manufacturer

Sanofi | November 17, 2020

When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant. The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at the contractor's site, the French drugmaker said Friday. A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA's letter was or what the nature of the deficiencies were. With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a "timely manner." The drugmaker didn't say how quickly it expected to turn around a new application. The untimely feedback from the FDA dims C1 inhibitor sutimlimab's chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.

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Jubilant Radiopharma and SOFIE Biosciences Ink Strategic Collaboration Agreement to Further Advance the Field of Molecular Imaging & Therapeutics

SOFIE Biosciences, Inc. | November 05, 2020

SOFIE Biosciences, Inc. ("SOFIE"), an established radiopharmaceutical supplier and worldwide radiopharmaceutical contract manufacturing organization, and Jubilant Radiopharma, a business division of Jubilant Pharma Limited, announced that both the organizations have entered into a strategic partnership. Under the terms of the partnership, Jubilant Pharma, via one of its wholly owned subsidiaries, with 25% of equity holding shall be a strategic partner to SOFIE, enabling SOFIE to continue to grow production capacity, advance its theranostic pipeline, and support novel PET diagnostic manufacturing and distribution within the U.S. "SOFIE is a beacon of innovation, and with Jubilant's deep experience, uncompromised quality and customer-centric operations, we will bring game-changing theranostic solutions to nuclear medicine," stated Sergio Calvo, President of Jubilant's Radiopharmaceuticals Division. "With this new relationship, SOFIE achieves another milestone in our innovation strategy," Philipp Czernin, SOFIE's Chief Revenue Officer, remarked. "By engaging a well-established industry partner such as Jubilant Radiopharma, SOFIE will leverage the combined market presence and astute organizational structure to deliver breakthrough compounds to the nuclear medicine community. With respective distribution capabilities and the highly complementary product portfolio of SPECT and PET radiopharmaceuticals, both companies are well poised to create a single-vendor opportunity in select geographies." As part of the agreement, Jubilant Radiopharma will invest US $25m into SOFIE Biosciences. This funding will help accelerate the readiness timelines for SOFIE's state-of-the-art Theranostics Center of Excellence Manufacturing Facility in Totowa, New Jersey, as well as advance the development of their Fibroblast Activation Protein Inhibitor (FAPI) program. Patrick Phelps, SOFIE's President and Chief Executive Officer stated, "Under this strategic partnership, SOFIE is excited to meet the growing need to manufacture highly specialized radiopharmaceuticals, as well as become the first theranostic production center for FAPI in the US. FAPI has received worldwide acclaim for its value as a key next-generation theranostic agent with the ability to greatly enhance the detection and treatment of a wide variety of oncology diseases, and we believe with Jubilant Radiopharma's investment and support, we can accelerate the development and commercialization of this exciting family of compounds." "This agreement is yet another demonstration of Jubilant Radiopharma's long term commitment to the global Nuclear Medicine community. Our teams are dedicated to bringing to market the next generation of breakthrough products and industry-leading services to healthcare providers across the globe as part of our mission of improving lives through Nuclear Medicine," stated Pramod Yadav, CEO Jubilant Pharma Limited. About SOFIE Biosciences, Inc SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (Theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value Theranostic intellectual property, SOFIE is poised to deliver on the promise of nuclear medicine.

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