Does Novartis delay in probing data manipulation claims spell trouble?

FiercePharma | August 23, 2019

Why did Novartis wait about two months before launching an internal probe into the alleged data manipulation surrounding gene therapy Zolgensma? Thats what officials at the FDA want to know. After an on-site inspection at AveXis control testing lab in Irvine, California, which appears to have been prompted by the firms communication of the problem to the FDA, inspectors issued a Form 483 on Aug. 2. The report noticed a delay from when the initial Zolgensma data allegation was flagged by a scientist on Mar. 14 to when a formal internal probe was opened on May 15. Two months seems like a lot, given that an FDA decision was looming, unnamed FDA officials toldThe Wall Street Journal. What happened during those two months? By Novartis’ account, before it started the full-on investigation in May, it “conducted an independent investigation with the support of external counsel to determine the extent of data discrepancies and whether they could be explained,” a company spokesman said. The reason why it took so long was because the preliminary probe “consisted of an extensive review of thousands of hand-written and electronic records concerning the life history of individual mice and a comparison of those records to entries on the hundreds of spreadsheets on which their data was recorded,” he said.

Spotlight

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Spotlight

Learn how predictive data analytics can drive new breakthroughs, accelerate big data solutions, and derive insights from publicly available data with this eBook from The Scientist and PerkinElmer, Inc. Thanks to technology, scientific research can now generate more data than ever before. However, the sheer volumes produced are outstripping the capacities and capabilities of traditional data analysis, thus potentially burying many key discoveries.

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PHARMACY MARKET

Fusion Pharmaceuticals has Signed an Agreement to Build a Radiopharmaceutical Manufacturing Facility

Fusion Pharmaceuticals | June 03, 2021

Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines; today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University, to build a 27,000 square foot Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be made by McMaster and equipped and validated by Fusion, will be designed to support the manufacturing of the Company's growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024. "Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization, and with Fusion's expertise, we believe we are well-positioned to create a facility to scale production in support of our growing pipeline and development collaborations," said Fusion Chief executive officer John Valliant, Ph.D. "We will continue to prioritize manufacturing and supply chain infrastructure in our long-term plans, and this facility is an important milestone in executing those plans. The location of the facility, adjacent to our internal research organization and a world-class University that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire top-tier talent to support our leading portfolio of radiopharmaceuticals." In conjunction with the execution of the lease agreement, Fusion has entered into a services agreement with its long-time partner, the Centre for Probe Development and Commercialization (CPDC), to provide services relating to certain aspects of the validation of this new manufacturing facility. 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 to deliver the alpha-emitting payloads to tumors selectively.

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RESEARCH

Eli Lilly wins FDA's emergency nod for COVID-19 antibody—but, thanks to mixed data, it's limited

Eli Lilly | November 11, 2020

The U.S. just had another COVID-19 drug authorized for emergency use. But the approval is limited—and, with at least one vaccine launch on the horizon, industry watchers wonder whether drugs to treat the illness have any staying power. The FDA authorized Eli Lilly’s bamlanivimab for emergency use on Monday, making it the first antibody therapy to win that distinction. Dubbed LY-CoV555, it's an anti-SARS-CoV-2 antibody therapy the Indianapolis pharma is co-developing with AbCellera. The OK comes with some caveats: It's limited to patients 12 years and older who aren't hospitalized but who are at high risk of developing severe illness, including elderly people and those with certain underlying conditions. And Lilly is advising infusion within 10 days of symptom onset.

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PHARMACY MARKET

CStone and LegoChem Biosciences Enter Global Licensing Agreement for New Antibody Drug Conjugate

CStone | October 29, 2020

CStone Pharmaceuticals declared today a permitting concurrence with Lego Chem Bio sciences, Inc, for the turn of events and commercialization of LCB71, a likely first-in-class/top tier immunizer drug form ("ADC"). Under the understanding, CStone gets the selective worldwide option to lead advancement and commercialization of LCB71 outside the Republic of Korea. LCB will get a forthright installment of US$10 million, and up to US$353.5 million in combined achievement installments, in addition to layered eminences. Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone, said: "We are very pleased to form this partnership with LCB, a leading ADC platform company, to obtain global rights to an asset with highly differentiated attributes in an exciting new field of oncology. The agreement adds the first ADC to CStone's development pipeline, and bolsters our precision medicine franchise with a new modality. We look forward to harnessing its full potential and bringing it to patients around the world." LCB71 is a pre-clinical ADC going into Investigation New Drug ("IND") empowering contemplates. It targets ROR1 (receptor tyro sine kinase-like vagrant receptor 1), a high-potential ADC focus for different strong and hematological malignancies. ROR1 protein articulation is common in an assortment of malignancies including different types of leukemia, non-Hodgkin lymphoma, and bosom, lung, and ovarian tumors. LCB71 has a restrictive tumor-actuated pyrrolobenzodiazepine ("PBD") expert medication poison that tends to the ordinary poisonousness issue related with conventional PBD payloads. It has shown total tumor hindrance over a few pre-clinical disease models, which may convert into a wide helpful record for a scope of strong and hematologic malignancies. Moreover, it uses site-explicit formation for an exact medication counter acting agent proportion. This backings serum half-life and improves its pharmacokinetic profile, and furthermore empowers homogeneous creation and huge scope fabricating. Dr. Yong-Zu Kim, CEO and President of LCB, said: "We are pleased to have reached this agreement with CStone, which has demonstrated extensive oncology expertise, especially in global clinical development. This partnership puts LCB71 on a path to development and commercialization for patients worldwide. We are convinced that CStone is the right partner to secure the future of this important drug." About CStone CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 15 drug candidates, including five late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide. About LegoChem Biosciences LegoChem Biosciences (LCB) is a clinical-stage biopharmaceutical company focusing on the development of next-generation novel therapeutics utilizing its proprietary medicinal drug discovery technology LegoChemistry and ADC platform technology ConjuAll. Since its foundation in 2006, LCB has focused on the research and development of Antibody-Drug-Conjugates (ADCs), antibiotics, anti-fibrotic and anticancer therapeutics based on proprietary platform technologies. Forward-looking Statement The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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