BMS’ Opdivo disappoints in late-stage trial

pharmatimes | June 26, 2019

Bristol-Myers Squibb has announced topline results from its CheckMate -459 trial evaluating Opdivo (nivolumab) in patients with unresectable hepatocellular carcinoma (HCC). The results show that the cancer drug failed to show superiority to Nexavar (sorafenib), and did not achieve statistical significance for its primary endpoint of overall survival. The news isn’t all negative, however, as a clear trend was demonstrated towards improvement in overall survival for patients treated with Opdivo compared Nexavar. The drug is currently being studied by the company across multiple settings and lines of therapy for HCC, including as monotherapy in the adjuvant setting and in combination with Yervoy (ipilimumab) for previously treated patients. The company say that they are still “encouraged by the promising efficacy and safety trends seen with Opdivo in CheckMate -459, especially as HCC is a devastating and difficult-to-treat cancer, for which there have been no significant advances over sorafenib, a standard treatment, in more than a decade,” said Bruno Sangro, head of the Liver Unit, Clínica Universidad de Navarra. Ian Waxman, development lead, Gastrointestinal Cancers BMS also commented that the company will “remain confident in the important role of Opdivo for the treatment of patients with HCC and look forward to evaluating insights garnered from this trial with the goal of ensuring patients with liver cancer have the opportunity to achieve the best possible outcomes.”

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BUSINESS INSIGHTS

SiO2 Materials Science and Doosan Corporation Enter Into Strategic Partnership to Accelerate Market Development in Asia

SiO2 Materials Science | December 27, 2021

Doosan Corporation, founded in 1896, one of South Korea's largest diversified conglomerates, and SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, announced an exclusive partnership to sell, market, and distribute SIO2's vial, syringes and blood collection tubes in Asia/Oceania. The partnership will focus initially on the pharmaceutical and diagnostics markets but will extend to other markets through the joint development of new technologies. As part of the strategic partnership, Doosan will invest $100 million into SiO2 and will additionally invest in substantial infrastructure and human resources for the acceleration of the business in Asia/Oceania. The partners have defined key volume milestones over a 15 year period. "The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines. South Korea has become a world leader in biological drug manufacturing, so it makes sense to establish a strong presence with a respected partners in the market," says Lawrence Ganti, President of SiO2 Materials Sciences The SiO2 Materials Sciences technology platform combines the benefits of glass and plastic while eliminating the drawbacks of both. The technology has been commercially validated through the packaging of hundreds of millions of COVID-19 vaccine doses around the world and is working with more than 100 active projects with leading pharmaceutical and diagnostic companies to bring their products to market in a safer container. The company was a key collaborator and part of the US Government's COVID-19 Response (formerly known as Operation Warp Speed) and has expanded its manufacturing footprint in Auburn, Alabama, more than 12-fold in the last 18 months. "South Korea is a strategic hub for biologic drug manufacturing. Doosan believes that the SiO2 technology would greatly support the packaging of these new drugs and vaccines and are proud to exclusively represent the technology in Asia," says Han Lee, Vice President of Doosan. "There is so much potential in the SiO2 technology, and we will also jointly develop new technologies and products by bringing our existing technologies and engineering minds together," says Chief Business Officer of Doosan Corporation. About SiO2 Materials Science SiO2 Materials Science is an advanced materials science corporation introducing breakthrough disruptive technology serving the biopharma, molecular diagnostic, and consumer healthcare industries. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California - Santa Barbara, University of Chicago, and MIT / Harvard. About Doosan Doosan Corporation is Korea's oldest conglomerate, founded in 1896. The company operates across multiple divisions such as: Electro-Materials, Industrial Vehicles, Fuel Cell Power, Retail, and Digital Innovation. The company is always developing innovative new business in support of materials science.

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PHARMACY MARKET

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. 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, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

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PHARMACY MARKET

Theralink® Technologies Expands Adoption of its Precision Medicine Technology in the Biopharmaceutical Industry

Theralink Technologies | April 20, 2022

Theralink Technologies a precision medicine company with a novel phosphoprotein-based assay for breast cancer, today announced that it has significantly expanded the adoption of its Laser Capture Microdissection and Reverse Phase Protein Array precision medicine technology to biopharmaceutical companies, including multinational healthcare corporations. The Company has supported 41 preclinical and clinical studies for 18 biopharma companies and is currently undergoing discussions to develop Companion Diagnostics with several of its existing clients. "We have partnered with some of the largest and most innovative global biopharma companies, driven by the unique value of our patented phosphoprotein precision medicine technology and our dedicated Theralink team of experts. I am encouraged by the rapid uptake of our biopharma offerings and excited by the significant market potential to develop Companion Diagnostics–tests required for oncologists to prescribe targeted drug therapy. We look forward to further expanding our technology across the industry to help bring life-saving therapies to patients in need, as well as equipping oncologists with insights to develop targeted treatment programs for their patients." Mick Ruxin, M.D., President & CEO of Theralink Technologies Leveraging its novel phosphoprotein-based assay, Theralink enables biopharma clients to expedite drug development and ultimately shorten time to market, which can potentially save millions of development dollars, by providing invaluable insights into a drug's biological impact. Theralink supports its partners across the entire drug development continuum from discovery to clinical market with services including: phosphoproteomic profiling in preclinical models and clinical samples, the evaluation of drug target inhibition within laser capture microdissected tumor samples, and interrogation of compensatory feedback mechanisms and pathways after drug target inhibition. In addition, the Company is in early discussions with several biopharma companies for the development of Companion Diagnostics. The development of Companion Diagnostics using Theralink's assays is a potentially large catalyst for Theralink, as well as its biopharma partners, as it is a required test by oncologists to determine a drug's suitability for their cancer patients. About Theralink Technologies, Inc. Theralink Technologies is a proteomics-based, precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity.

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BUSINESS INSIGHTS

CCT Research Announces New Partnership with BEKHealth

CCT Research | February 18, 2022

CCT Research has announced an exciting partnership with BEKHealth. The collaboration streamlines access to electronic medical records (EMR) data, across CCT sites and drives a data-driven approach to trial execution and management. CCT has established itself as an innovator in conducting clinical trials. Using BEKHealth, a provider of software solutions for enhancing clinical research processes, will enable CCT to more accurately identify and fit studies to its sites. The deep commitment by both companies to improving the outcomes of clinical trials made the relationship a natural fit. “One of CCT’s driving forces is to promote an environment of innovation and continuous improvement. Our partnership with BEKHealth strengthens our ability to identify potential research participants, ultimately creating greater accessibility to clinical trials.” Jennifer Kocour, President, CCT Research More than just a “technology” partnership, this collaboration with BEKHealth is also patient-centric– which remains a top priority for CCT. Once studies are awarded, it will power onsite research by identifying patients who fit studies best, saving sites, patients, and staff time and hassle. “At the individual site level, our goal is to optimize research to be as beneficial to the practice and its patients as possible with minimal disruption to the clinics day-to-day operations. We view data and technology as central to that strategy and couldn’t be more excited to work with BEKHealth,” said Kyle McAllister, Vice President, Data & Analytics, CCT Research. “The breadth and depth of CCTs network was an exciting opportunity. The ability to leverage technology to centralize key drivers of success such as feasibility, site selection, patient recruitment and analytics drives a new paradigm in clinical research,” said Jason Baumgartner, CEO and Founder, BEKHealth. “Our platform is secure and activation creates a minimal burden on IT teams. What this means for the provider and patient is our collaboration will have a major impact quickly.” “We provide an integrated clinical operating platform that enables companies to streamline research across multiple key processes,” said Josh Ransom, PhD, Vice President, Customer Experience, BEKHealth. “Ultimately this means our partners can scale their businesses faster by improving operational efficiency while taking out manual and inefficient steps.” About CCT Research CCT Research is a network of clinical research sites embedded in the offices of skilled physicians conducting clinical trials to offer patients with innovative medical treatments and safe, effective care options. CCT Research was founded in 2017 and has more than 20 locations across Arizona, Georgia, Kentucky, Nebraska, Nevada, and Utah. The sites are located within physicians’ offices, within ACO networks, and several dedicated research centers. CCT supports research in Neurology, Family Practice, and Dermatology, with plans to include additional therapy areas soon. The company's unique model simplifies the process for trial participants and provides pharmaceutical sponsors with high-quality data.

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Spotlight

Accenture surveyed CMOs (or equivalent titles) and CIOs from many of the largest pharmaceutical companies ($5B+) in the world to understand the options, challenges and points of view of senior marketing and IT executives on the impact of digital strategies and capabilities on their business.

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