EXPEDITED APPROVAL OF FDA-APPROVED DRUGS IN AUSTRALIA

| November 3, 2016

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In the past, after gaining approval for a drug/device in the United States, subsequent approval in Australia involved significant duplicated effort and additional regulatory hurdles.

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Molecule is a software platform to accelerate innovation in the pharmaceutical industry. It connects scientists, patients and industry to advance drug development in a collaborative open market.

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Top Pharmaceutical Firms Urge FDA to Adopt Blockchain for Drug Tracking

Article | February 25, 2020

Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDA), according to reports on February 24, 2020. Though nascent, blockchain technology, the building blocks of Bitcoin (BTC) and other cryptocurrencies are fast gaining ground across various ecosystems, due to its immutability, security, privacy, and other intricate properties. In the latest development, 25 leading manufacturers of pharmaceutical products, logistics partners and other market participants in the pharma supply chain, have published a report that highlights the importance of blockchain technology in drug traceability.

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Roche Prepares to Launch COVID-19 Antibody Test System

Article | April 17, 2020

Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease. This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19. Roche is eying May for the launch of the test in Europe and is in talks with the U.S Food and Drug Administration for emergency approval of the system. Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms, the company said. Roche noted that as more information becomes available about immunity levels to COVID-19, society can return to a sense of normal much more quickly. Roche’s test will join a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies.

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How pharma can continue engaging HCPs in a world gripped by COVID-19

Article | April 10, 2020

Medscape is the leading source of clinical news, health information, and point-of-care tools for healthcare professionals. Medscape offers specialists, primary care physicians, and other health professionals the most robust and integrated medical information and educational tools. Medscape Education (medscape.org) is the leading destination for continuous professional development, consisting of more than 30 specialty-focused destinations offering thousands of free CME and CE courses and other educational programmes for physicians, nurses, and other healthcare professionals. Both Medscape and Medscape Education are part of WebMD Health Corp., an Internet Brands company. Face-to-face interactions between pharma and physicians have essentially ceased overnight during the COVID-19 pandemic, but that doesn’t mean HCPs have stopped looking for new medical information.

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Decentralized Clinical Trials: Imperative for Pharma Sector to fight COVID19

Article | April 3, 2020

These are unprecedented times. The world is mobbed by a contagion virus, putting people’s health at risk, threatening to destabilize economies. It has already put global healthcare systems under tremendous pressures, and managed to resist efforts to contain it. Even though coronaviruses are not new, this COVID-19 strain has created panic and forced us to be locked down in our homes sans any movement for weeks, if not months. Organizations are fighting an intense battle to keep their workforce safe, minimize risk, and ensure business continuity. For the Life Sciences industry, however, the challenge is even more significant. The whole world is looking at them to come up with a vaccine and a cure. But that is easier said than done. Bringing a new drug to market is an uphill battle and requires rigorous clinical trials. This process already has regulatory challenges. With the current lockdown situation, the Pharma community is grappled with the challenge of continuing some of the critical and time-sensitive in-flight trials so that their regulatory submission, registration, and market entry are not impacted. But all may not be lost. With the right technology solution, it is possible to turn the situation around rapidly.

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Molecule is a software platform to accelerate innovation in the pharmaceutical industry. It connects scientists, patients and industry to advance drug development in a collaborative open market.

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