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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
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.
The Purple Book—a database containing information about all licensed biological productsis set for a revamping that offers more patent transparency regarding reference biologics.
Last month, the Russian government passed a decree (the Decree) amending the rules on state regulation of ceiling prices for drugs included into the Vital and Essential Drugs List, which is approved annually.
The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update.
Law360 published an article on August 18, 2018, by Morgan Lewis life sciences lawyers that discusses the FDA’s plans to advance biosimilar products.
In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation.