COVID-19 vaccine news continues to dominate headlines as candidates from several companies move closer to obtaining emergency use authorization from the Food and Drug Administration. Also on the drug approval front, tech giant Palantir and the FDA entered into a $44 million deal for the agency to use the company’s software in its review process. Plus, we take a look at recent developments in telemedicine therapies, sickle cell disease treatments and permanent changes to clinical trials as a result of the pandemic.
This is the first installment of a new weekly roundup in which we highlight five things you need to know about in the life sciences industry. Here’s the latest.
The biggest news this week is the FDA’s endorsement of the Pfizer/BioNTech COVID-19 vaccine. In documents released Tuesday, FDA reviewers called the vaccine “highly effective,” as this article from STAT reports.
The FDA will have an advisory committee review of the vaccine on Thursday, another step in determining whether the vaccine will be approved for emergency use in the United States. In the UK, the first doses have begun to be administered. There may, finally, be some light at the end of the pandemic tunnel.
(Bonus reads: The AstraZeneca/Oxford vaccine results are good, but not as positive as the Pfizer or Moderna vaccines, this STAT piece explains. Plus, how will distribution of a vaccine really work?)
The FDA has entered into a new agreement with tech giant Palantir to use its technology to enhance the tools used in drug reviews and inspections.
When pharmaceutical companies submit information to the FDA for drug approval, the agency performs its own statistical analysis to vet the potential drug. This $44 million deal means the Center for Drug Evaluation and Research (CDER) and Oncology Center of Excellence – both part of the FDA – will leverage Palantir software tools to support their drug analysis and recommendations.
Digital therapeutics company Pear Therapeutics’ whopping $80 million funding round is one of the latest examples of how the pandemic is driving adoption of new technologies and fueling the growth of existing remote treatment options such as telemedicine.
Pear has a number of telemedicine treatments for both addiction and insomnia. Financing deals such as this one demonstrate that, although the pandemic will one day come to an end, more widespread adoption of telemedicine is here to stay.
Historically, there have been poor treatment options for people with sickle cell disease, but several companies are making progress toward new therapies. CRISPR Therapeutics and Vertex Pharmaceuticals announced results of their CTX001 trial earlier this month, followed by news of promising results from Bluebird Bio’s sickle cell gene therapy clinical trial (though it’s important to note that the study is small). The fact that multiple companies have recently achieved positive results is a welcome development for a disease that has had limited options in the past.
2020 has forced contract research organizations and sponsors to rethink how they execute on clinical trials. These changes were driven by necessity, but are here to stay even as the clinical trial environment eventually returns to some semblance of normal. In this video, sponsors and CRO leaders discuss how the pandemic has forced clinical trials to become more flexible, what we have learned in 2020 and which changes will have longevity.