This week we explore a partnership between a large biopharma and a machine learning startup. In addition, we look at a non-commercial approach to address the global COVID-19 vaccine shortage, a major mRNA-focused acquisition, a temporary pause on factory inspections, and finally, 55 new drug approvals in 2021.
Each week, we highlight five things you need to know in the life sciences industry. Here’s the latest.
Artificial intelligence and machine learning are a recurring theme in drug discovery as companies look for ways to streamline the hunt for molecules that both provide clinical benefit while not causing undesirable side effects. Machine learning refers to technology that allows machines to search through large volumes of data to both recognize patterns and predict outcomes. Given the near endless variety of compounds that could be screened for use in new drugs, companies like Amgen are looking for partners like Generate Biomedicines to bring this technology and toolsets to their drug discovery efforts.
As the world grapples with the latest surge of COVID-19 cases fueled by the more transmissible omicron variant, the need to ensure that everyone globally has access to vaccines seems more urgent than ever. A new vaccine developed at a children’s hospital in Texas is hoping to help, and avoid many of the challenges that commercial companies face when selling a vaccine into widely different countries. By giving up their financial interests in the vaccines, the developers hope that it can be widely manufactured and distributed in countries where the costs of current vaccines can be prohibitive.
German based Merck KGaA announced that it had acquired Exelead, a contract development and manufacturing organization for approximately $780 million. Exelead specializes in the development and manufacturing of lipid nanoparticles, a key component in the formulation of mRNA therapeutics. At the beginning of last year, Merck Group also acquired AmpTec, a leading provider of RNA technology products. Both acquisitions significantly expand Merck’s experience and capability to deliver mRNA based vaccines, treatments and diagnostics.
Due to the recent surge in COVID-19 cases, the Food and Drug Administration announced this week that it was temporarily pausing domestic factory inspections to “ensure the safety of its employees and those of firms it regulates.” In November, the FDA published a report detailing the impact COVID-19 had on its inspection activities and its plan to return to what it referred to as “standard operational levels.” It noted a backlog of 52 new drug applications because of the delays.
Despite the challenges due to COVID-19, the biopharma industry managed to receive 50 FDA approvals for new drugs last year. This is in line with the number of approvals granted in 2020, up slightly from 49 in 2019 but down slightly from 58 in 2018. It’s important to note that the list only includes full FDA approvals, therefore it does not include the COVID-19 vaccines from Moderna or Johnson & Johnson because those were granted emergency-use authorization. A full list of the drugs approved can be found here.
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