AstraZeneca spinoff Viela Bio scored its first FDA nod. Can it face down heavyweight rivals?

Fiercepharma | June 16, 2020

Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplinza following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch. Doctors could prescribe Roche’s Rituxan or its biosimilars off label before trying Uplinza, Evaluate Vantage reports, or payers could require them to try the cheaper options first. Uplinza is a B cell depleter like Rituxan, so if those older options don’t work, docs might go another route and try Alexion’s Soliris rather than move on to Uplinza, Vantage said.

Spotlight

Pharmaceuticals play a prominent role worldwide. This widespread presence is met with regulatory requirements at each phase of pharmaceutical development and manufacturing—from inspection of raw materials to quality control of final products. Consistently producing pharmaceuticals that both continue to satisfy the consumer and adhere to regulatory mandates, requires analytical methods, instruments, and systems that ensure quality standards are upheld throughout the pharmaceutical industry.

Spotlight

Pharmaceuticals play a prominent role worldwide. This widespread presence is met with regulatory requirements at each phase of pharmaceutical development and manufacturing—from inspection of raw materials to quality control of final products. Consistently producing pharmaceuticals that both continue to satisfy the consumer and adhere to regulatory mandates, requires analytical methods, instruments, and systems that ensure quality standards are upheld throughout the pharmaceutical industry.

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BUSINESS INSIGHTS

INNOTECH and OSARO Collaborate to Build a Demonstration AI Picking Robot System for Rohto Pharmaceutical’s Next-generation Smart Factory

INNOTECH and OSARO | January 12, 2022

OSARO Inc. a global leader in the development and provision of advanced robotics automation, and INNOTECH CORPORATION, which provides advanced products for electronics and consumer industries, have announced a collaboration to create an innovative demonstration for Rohto Pharmaceutical Co., Ltd. using AI piece-picking robots. The two companies are jointly providing picking robots and jointly building a system for their introduction into a new factory production line, scheduled for completion in 2022. OSARO will take the lead in providing AI software to improve the efficiency of robot operations, and INNOTECH will provide support from demonstration testing to integration of the AI software. By automating the picking of bottle products, one of the most labor-intensive tasks in the production process, with robots, the collaboration aims to reduce the workload and improve productivity at the Rohto factory. Rohto produces OTC medicines, beauty products and supplements. In the eye care category, sales of OTC eye drops account for more than 40 percent of the Japanese market. “We are honored to have OSARO's picking technology recognized by the next-generation smart factory of Rohto Pharmaceutical Co. We believe that the ability to integrate with existing equipment is a great advantage to create a new model case for Japan’s future factories and warehouses.” OSARO CEO Derik Pridmore Yosuke Kaburaki, Director, INNOTECH CORPORATION stated: “We have been conducting basic experiments with Rohto Pharmaceutical using robots that incorporate OSARO's AI software. In the future, INNOTECH will continue to speed up the integration of OSARO's software technology into Rohto's production process to make it more effective and efficient.” About INNOTECH CORPORATION Yokohama City, Kanagawa Prefecture, Japan INNOTECH provides comprehensive technology and support solutions for customer product development and manufacturing. Since 2000, INNOTECH has engaged in the business of internally developed products, leveraging its technical knowledge, strengthened by its existing and expanding business relationships. Today, INNOTECH continues to evolve as a total solution company, with hardware, software, consulting and support offerings for customers’ design, development, and mass production activities, leading up to the introduction of their final products. About OSARO, San Francisco, CA, USA OSARO designs and deploys robotics automation solutions in the materials handling industry using software-defined robotics. OSARO automation systems bring together advanced machine learning for object recognition with powerful control software that adapts to customer data and environments. The company’s robotic piece-picking solution is optimized for grocery, cosmetic, and e-commerce markets, where key challenges include high SKU inventories, complex packaging, and fragile items requiring delicate handling. OSARO Solutions have been validated by the world’s leading retailers, system integrators, and third-party logistic companies.

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PHARMA TECH

AstraZeneca, Daiichi Sankyo push Enhertu closer to the blockbuster frontier with stomach cancer

Daiichi | January 20, 2021

Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland. The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday. An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer. In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm. Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu. Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.

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Intec Pharma Announces New Research Collaboration Agreement with MSD

Intec Pharma | October 08, 2020

Intec Pharma Ltd. ("Intec" or "the Company") today announces it has entered into a new research collaboration agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. Details of the agreement are confidential. "We are very excited to continue to work with MSD," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "This new agreement builds upon the relationship we have enjoyed in prior research and allows the companies to leverage their combined experience in delivery."

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