A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,” “product hopping,” and “sham” citizen petitioning. Versions of some of these bills had been under consideration by this subcommittee for years, but had not been voted out of committee until now.
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.
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.
US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products.
The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List of Approved Drug Products with Therapeutic Equivalence Evaluation (referred to as the Orange Book). Historically, FDA’s Orange Book role has been solely ministerial. However, over the next year, FDA may begin taking a more active approach to the Orange Book.
In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously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.