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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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BUSINESS INSIGHTS

ERT Expands Clinical Imaging Reporting Capabilities in its Business Intelligence Suite

ERT | April 16, 2021

ERT, the worldwide pioneer in clinical endpoint data collection, today declared that its demonstrated Business Intelligence suite has extended to incorporate detailing for clinical preliminary imaging, making study data all the more effectively available and noteworthy. The new imaging capabilities give an elevated degree of data that empowers study pioneers to guarantee consummation, and successfully oversee locales, expenses, and profitability. "Imaging studies are complex, and customers are under great pressure to monitor and manage their performance. With the power of our Business Intelligence suite, study leaders can achieve the deep insights they need to act quickly, and keep studies on track for success," said Tim Kulbago, Vice President, Imaging, ERT. "Our clinical trial imaging customers can now track their study progress all the way from first image capture to database lock, with the ability to pivot with confidence whenever a potential challenge arises." ERT's Business Intelligence suite permits numerous CROs and patrons to acknowledge new operational efficiencies and better data quality, alongside diminished investigation courses of events and lower costs, through its effectively edible and thorough perspectives into preliminary execution. Clients can utilize the new imaging functionality to coordinate investigations utilizing a profundity of data at no other time accessible. With the new capabilities, they approach a straightforward dashboard for surveying early markers of likely postponements in the imaging process. Clients will track down a natural interface that permits them to get to consider data in an assortment of ways. They can undoubtedly channel data for an undeniable level view or jump down into points of interest by district, site and picture peruser, among others. Checking consistence is straightforward, as clients can rapidly see a general investigation level or take a gander at consistence in explicit territories like quality control, by site, and even by picture peruser. Opportune data permits study pioneers to intercede as vital, for instance, if a site has a high number of inquiries or if a peruser has all the earmarks of being going amiss from the convention. About ERT ERT (eResearch Technology) is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what's next, so it can adapt without compromising standards. Powered by the company's EXPERT® technology platform, ERT's solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. In 2019, 75% of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs, and CROs have relied on ERT solutions across 16,000 studies, spanning more than five million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.

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PHARMA TECH

Piramal Pharma Solutions Announces Sterile Fill/Finish Program Theratechnologies Inc

Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021

Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation. The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients." About Piramal Pharma Solutions Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide. About Piramal Pharma Limited Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group. About Theratechnologies Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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Spotlight

By becoming a member of our Development Programs, you can start building your career with a global biopharma leader and help us create remarkable impact for patients. Do you share our passion to make a better tomorrow.