Federal court puts kibosh on Trump plan for drug prices in TV ads

pharmaphorum | July 10, 2019

A federal judge has blown a hole in an attempt by the Trump administration to force drugmakers to put the list prices of their medicines in TV advertising. The measure – which had been due to come into effect just a few hours after the verdict – would have required the wholesale acquisition price (WAC) of any medicine that costs more than $35 per month to be revealed during the commercial, in the hope of shaming drugmakers into lowering their process. The pharma industry has insisted that it is unfair as the list price does not take into account discounts or rebates that might be offered, did not give a reflection of patient out-of-pocket costs, and that the Department of Health and Human Services (HHS) overstepped its regulatory powers in ordering the move. This week, District Judge Amit Mehta, presiding over a court in Washington, DC, agreed and in a ruling called an immediate halt to the initiative. In the judgment, Mehta wrote that the policy “could very well be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiralling drug costs may be, HHS cannot do more than what Congress has authorised.”

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With over 30 years of experience in supporting pharmaceutical, biopharmaceutical and biotechnology companies through the provision of outsourced cGMP compliant Chemistry, Manufacturing and Control (CMC) and human genetics testing, Tepnel Pharma Services is positioned to provide CMC support for drug development, whilst also providing a companion diagnostic solution which addresses the requirements of personalised and stratified medicines.


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BUSINESS INSIGHTS

Iktos and The University of Dundee, Drug Discovery Unit (DDU) Announce a Collaboration to Use AI for Drug Design and Retrosyntheis

Iktos | December 20, 2021

Iktos, a company specialized in Artificial Intelligence for new drug design, and The Drug Discovery Unit (DDU), School of Life Sciences, The University of Dundee, focused on the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery, announced entering a collaboration to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of DDU’s drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies, its AI-based retrosynthesis analysis and planning tool Spaya™, and know-how complementing DDU’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties. The DDU was established in 2006 to respond to a lack of drug targets identified for neglected tropical diseases being translated into therapeutics for diseases impacting the poorest people in the world. The DDU translates basic science into lead compounds to validate putative drug targets, to use as tools to investigate disease pathways and, when appropriate, advance to pre-clinical drug candidates for multiple diseases, e.g. TB and cancer. Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through Iktos’s other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate. Iktos has recently diversified its R&D efforts into the development of an AI technology for retrosynthesis. Identifying and selecting synthetic pathways is one of the most challenging and time-consuming tasks in synthetic and medicinal chemistry. Iktos has developed AI based retrosynthesis analysis and planning tool Spaya™ by harnessing the power of data-driven retrosynthesis algorithm for systematic exploration and prioritisation of synthetic routes for a desired compound in minutes. “We are thrilled to be working with Iktos to drive our projects towards drug candidates. Iktos AI platform combined with our own in-house computational and medicinal chemistry design teams provide a powerful combination for innovative new drug design.” Professor Paul Wyatt, Head of the DDU “We are thrilled and proud to join forces with DDU with the aim to help in the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery,” commented Yann Gaston-Mathé, President and CEO of Iktos. “Pleased to have earned DDU’s trust, we are confident that together with DDU and their established R&D partners, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The feedback from DDU’s research team will be highly valuable as we improve our product offerings. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects.” About DDU The Drug Discovery Unit (DDU) (est. 2006) within the School of Life Sciences at The University of Dundee is a fully integrated, Biotech-style, drug discovery centre working across multiple disease areas. The DDU collaborates with partners to translate world-class biology research into novel drug targets and candidate drugs to address unmet medical need. About Iktos Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis.

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BUSINESS INSIGHTS

TIKOMED and IQVIA announce a strategic collaboration for the development of TIKOMED's lead drug platform candidate ILB®

Tikomed | May 09, 2022

Swedish biopharmaceutical company TikoMed AB and IQVIA announce a key strategic collaboration with the aim to accelerate the development of TikoMed's lead drug platform candidate ILB®, a broad-spectrum small molecule drug candidate with curative potential in a wide range of diseases driven by acute and chronic inflammation. The collaboration will support TikoMed's clinical development, regulatory and commercial strategies. IQVIA brings together deep therapeutic expertise, unparalleled data, and technology alongside flexible operating models to enable biopharma organisations such as TikoMed to accelerate the clinical development and commercialisation of innovative products that improve patient lives. "We are thrilled to have IQVIA involved supporting TikoMed with the next steps in our journey to improve human life by enhancing the body's natural ability to self-repair and regenerate. With our highly scalable proprietary drug platform we aim to provide safe, effective and affordable therapies to as many patients as possible across the globe", CEO Anders Kristensson Fiona Stewart, Head of Strategic Alliance Management Europe from IQVIA said "We are delighted TikoMed has selected IQVIA to strategically collaborate in the development of ILB®. We look forward to leveraging our depth of experience to help accelerate the availability of these medicines to the patients who need them the most." TikoMed was advised by The Connecting Architects on this strategic collaboration. TikoMed AB TikoMed is committed to improve human life by exploring and harnessing the medical potential of the body's ability to self-repair and regenerate. With an adaptive, multi modal mechanism of action, TikoMed's drug platform rebalances the body's inflammatory, immune and fibrotic responses to acute and chronic inflammation in order to enhance self-repair and regeneration. Currently applied as a therapy in neurodegeneration and an enabling technology for advanced therapies, the initial development programs include ALS, TBI and islet cell transplantation. Broader use of the drug platform will be considered for a wider range of diseases using a creative business and financing model. TikoMed's highly scalable proprietary technology aims to provide safe, qualitative and affordable medicine to as many patients as possible across the globe. TikoMed is privately-owned and based in Viken, Sweden. IQVIA IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility - enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 79,000 employees, IQVIA conducts operations in more than 100 countries.

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BUSINESS INSIGHTS

Titan Pharmaceuticals Announces Pricing of $5.5 Million Registered Direct and PIPE Offering Priced At-The-Market

Titan Pharmaceuticals, Inc. | February 03, 2022

Titan Pharmaceuticals, Inc. announced that it has entered into a securities purchase agreement with a single institutional investor to purchase 3,374,242 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Titan has also agreed to issue and sell to the investor 1,289,796 pre-funded warrants, at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue to the investor in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,664,038 shares of common stock. The combined offering price of each share or pre-funded warrant and each warrant will be $1.18. The warrants will be immediately exercisable, will expire on the five year and six month anniversary of the issuance date and will have an exercise price of $1.14 per share. The aggregate gross proceeds to the Company of both offerings is expected to be approximately $5.5 million. The offerings are expected to close on or about February 4, 2022, subject to the satisfaction of customary closing conditions. Maxim Group LLC is acting as the exclusive placement agent in connection with the offerings. The shares of common stock in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The pre-funded warrants and warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock issued in the registered direct offering will be filed by Titan with the SEC. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US (FDA), EU and Canada.

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PHARMA TECH

ADDING MULTIMEDIA Entos Pharmaceuticals Expands R&D Operations into the US

Entos Pharmaceuticals | June 08, 2022

Entos Pharmaceuticals, a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, announced today the opening of its new 9,600 square foot research and development facility in the Torrey Pines community of San Diego, California. This collaborative space will be shared with Entos’ sister companies, Oisín Biotechnologies, OncoSenX, and Aegis Life, allowing the companies to expand their team and infrastructure and support continued growth. Entos’ new office and lab space is located at the MUSE in Torrey Pines, a redeveloped 186,000 square foot life sciences property completed in 2021. Featuring three buildings, the campus was designed with walking paths, a locally-sourced restaurant, and conference space with indoor and outdoor seating. The US location complements Entos’ existing Canadian headquarters and R&D facilities in Edmonton, Canada, and new offices in London, UK. “We’re excited to move into our new lab space in San Diego, which is becoming one of the largest biotechnology hubs in the world for pharmaceutical research and innovation. This is a significant milestone for Entos as we continue developing genetic medicines for some of our most challenging diseases.” John D. Lewis, Ph.D., founder, and CEO of Entos Pharmaceuticals Entos’ proprietary Fusogenix PLV drug delivery system is formulated with FAST proteins to enable the delivery of nucleic acid cargo, such as DNA and RNA, directly into target cells. This technology is applicable to a wide range of genetic medicines. Unlike conventional lipid-based and viral-based delivery systems, Fusogenix PLVs have demonstrated, in multiple studies, to be well tolerated at high systemic doses, redosable, and able to target multiple tissues in the body. This announcement comes on the heels of two significant collaborations that began in late 2021, granting exclusive rights to Entos’ Fusogenix PLV nucleic acid delivery technology to research, develop and commercialize therapeutic genetic medicines. The first agreement was with BioMarin to target certain rare diseases. The second was a license agreement with Eli Lilly for multiple programs for central and peripheral nervous system diseases and came with an initial payment of $50M and $400M in milestones per program. About Entos Pharmaceuticals A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and redosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of nucleic acid into target cells through direct fusion.

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Spotlight

With over 30 years of experience in supporting pharmaceutical, biopharmaceutical and biotechnology companies through the provision of outsourced cGMP compliant Chemistry, Manufacturing and Control (CMC) and human genetics testing, Tepnel Pharma Services is positioned to provide CMC support for drug development, whilst also providing a companion diagnostic solution which addresses the requirements of personalised and stratified medicines.

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