NICE to work with GW Pharma after Epidiolex rejection

PharmaTimes | August 27, 2019

The National Institute for Health and Care Excellence (NICE) has announced its intention to work with GW Pharma to address the issues highlighted by its independent appraisal committee, after it rejected the company’s Epidiolex (cannabidiol). The organisation did not recommend the drug in combination with clobazam for treating Dravet and Lennox-Gastaut syndromes, types of epilepsy which begin in early childhood and which are lifelong and difficult to control. The rejection occurred as the committee noted that despite the clinical trial evidence showing that the combination reduces the number of the main types of seizures associated with epilepsy, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of the treatment is still uncertain. The committee also cited concerns about the economic models provided by the company. Importantly, they concluded that the models may not capture all aspects of severe treatment-resistant epilepsy that are important to people with these conditions, and to their carers and families. Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said that the committee was “not convinced about the way the company had modelled the effect on people living longer or having a better quality of life.”

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PostEra spearheads AI-driven drug discovery collaboration to develop antiviral therapeutics with initial $68M in NIH funding

PostEra | May 19, 2022

PostEra, a biotechnology company specializing in machine learning for preclinical drug discovery, announced a multi-year collaboration with the National Institutes of Health to develop small molecule antiviral therapeutics to prevent pandemics. The center will receive initial funding of $68M. PostEra co-leads this initiative with the Drugs for Neglected Diseases Initiative, a global charity with expertise in drug development for global equitable access, and the Memorial Sloan Kettering Cancer Center. As part of the National Institutes of Health's National Institute of Allergy and Infectious Diseases Antiviral Program for Pandemics, the AI-driven Structure-Enabled Antiviral Platform (ASAP) consortium aims to discover dozens of lead compounds against key viruses of significant pandemic concern, such as flaviviruses (responsible for endemic diseases such as Dengue and Zika), picornaviruses (including potentially debilitating enteroviruses as well as other cold-causing viruses), and coronaviruses. ASAP will further deliver three IND-ready candidates which can be immediately ready for clinical evaluation in the event of a viral outbreak, so that future pandemics can be halted before severe outbreaks occur. The consortium is committed to making resulting antivirals globally and equitably accessible, so that no patient population is left behind. ASAP will use PostEra's end-to-end AI-first approach to accelerate the discovery process, generating molecules with optimised properties, designing rapid synthesis, and optimally prioritising experiments. In particular, AI approaches are tightly integrated into structural biology to realize next generation structure-based design. ASAP is built on the success of the COVID Moonshot project, a global open-science AI-driven initiative that began in March 2020 and rapidly identified antiviral drug candidates that target the main protease of the SARS-CoV-2 virus. "We are honored to be co-leading this consortium. We believe that our AI platform will accelerate the discovery of therapeutics that will prevent pandemics." Dr Alpha Lee, Chief Scientific Officer of PostEra, who co-founded COVID Moonshot About PostEra PostEra was founded in 2019 and its technology is built on pioneering academic research done by its founding scientists. PostEra's technology addresses some of the key challenges in drug discovery R&D by integrating molecular design with chemical synthesis. PostEra advances small molecule programs through partnerships with biopharma, working on its own internal pipeline, and also offering some of its synthesis technology via its Manifold web platform. PostEra also helped launch the world's largest open-science drug discovery effort; COVID Moonshot, along with an NIH-funded antiviral research center for the prevention of future pandemics.

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PHARMA TECH

Nucleai Announces a Partnership with Sirona Dx for AI-Driven Discovery of Novel Spatial Biomarkers in Solid Tumors

Nucleai and Sirona Dx | July 14, 2022

Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, today announced a collaboration to advance the discovery of novel spatial biomarkers in solid tumors. The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials. Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022. “Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging. This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy.” Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook. “We are delighted to announce a partnership with Nucleai,” said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. “Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine.” About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. About Sirona Dx Sirona Dx is a technical, CLIA accredited CRO, founded in 2016 to accelerate the pace of immunotherapy and targeted therapy development. With a leading-edge menu of specialized high complexity, single-cell proteomics and genomics services, Sirona Dx supports exploratory biomarker programs and advanced precision medicine initiatives to deliver safer and more effective treatment solutions.

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BUSINESS INSIGHTS

invoX Pharma Extends Tender Offer to Acquire F-star Therapeutics, Inc.

invoX Pharma Limited | August 05, 2022

invoX Pharma Limited a wholly owned subsidiary of Sino Biopharmaceutical Limited focused on research and development and business development activities outside of China, and F-star Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that invoX has extended the expiration of its previously announced tender offer for all of the issued and outstanding shares of F-star common stock for a price of $7.12 per share. The tender offer is now scheduled to expire at 05:00 p.m., Eastern Time, on September 19, 2022, unless it is further extended. The tender offer was previously scheduled to expire at one minute after 11:59 P.M., Eastern time, on August 3, 2022. The tender offer is being extended in order to allow additional time for the satisfaction of the regulatory conditions to the offer. The depositary for the tender offer has advised invoX that as of the previous expiration time there were validly tendered and not withdrawn a total of approximately 13,026,582 shares of F-star common stock, and approximately 2,704,867 shares of F-star common stock tendered pursuant to a notice of guaranteed delivery. All terms and conditions of the tender offer remain unchanged during the extension period. F-star shareholders who have already tendered their shares do not have to re-tender their shares or take any other action as a result of the extension. Complete terms and conditions of the tender offer are set forth in the Offer to Purchase, Letter of Transmittal and other related materials, which have been filed by invoX with the Securities and Exchange Commission on July 7, 2022, as amended. In addition, F-star filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC on July 7, 2022, as amended, which includes, among other things, the recommendation of F-star’s board of directors that F-star stockholders tender all of their shares in the tender offer. The Information Agent for the tender offer is Innisfree M&A Incorporated. The Depositary and Paying Agent for the tender offer is Computershare Trust Company, N.A. For all questions relating to the tender offer, please call the Information Agent, Innisfree M&A Incorporated toll-free at (888) 750-5830; banks and brokers may call collect at (212) 750-5833. About invoX invoX was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, invoX aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. Sino Biopharm’s product offerings include a variety of biologics and small molecule drugs, and in therapy areas that include hepatology, oncology, cardiovascular and cerebrovascular diseases, orthopaedics, digestive and immune and respiratory diseases. About F-star F-star is a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and have improved lives. F-star is committed to working towards a future free from cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. F-star has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising immuno-oncology targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. F-star has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

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