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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
While it may feel like FDA’s attention has been focused on COVID-19 for nearly two years, as we have written about in a previous blog post, FDA is looking to the future, and particularly, one that signals exciting prospects for biotechnology products, including cell and gene therapies. This is mirrored by the increasing financial strength of the biotechnology industry. The Alliance for Regenerative Medicine reports that regenerative medicine and advanced therapy financing soared during the first half of 2021, resulting in the strongest half year to date, and reached 71% of 2020 full year levels. Moreover, the Alliance reports that there are now more than 1,200 companies worldwide developing advanced biotechnology products and an anticipated 18 global regulatory approval decisions this year. Also, 243 regenerative and advanced therapy phase 3 trials were ongoing at the time of the Alliance’s report.
Last year was a record-breaking one for capital raising in life sciences, and 2021’s first quarter was robust for special purpose acquisition company (SPAC) transactions. Now, after a second-quarter SPAC and initial public offering (IPO) slowdown, the outlook for summer SPACs has rebounded just in time for the Morgan Lewis Global Public Academy program, Going Public Through a SPAC: Current Issues for SPAC Sponsors and Private Companies 2021. Our panelists will discuss some of the most important legal issues for companies considering going public through a SPAC and for SPACs seeking an acquisition target. Topics covered will include the use of private investments in public equity (PIPEs), obtaining shareholder approval for a merger, and the required SEC filings and review process.
Human cell and gene therapy research has advanced dramatically in recent years and opened the door to potential treatments for diseases once considered incurable.