Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in Delaware alleging their COVID-19 vaccine lipid nanoparticle technology infringes Alnylam’s patent rights. The patents-in-suit are U.S. Patent…
On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). According to the Senate…
As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory, market, and legal developments impacting biosimilars. We start today with our picks for…
Revance Therapeutics, Inc. recently announced that, because of COVID-19 travel restrictions, the FDA has been unable to complete its inspection of the manufacturing facility for Revance’s DaxibotulinumtoxinA for Injection biologic. A letter from the FDA indicated that there were no other issues with the DaxibotulinumtoxinA BLA, but that the BLA…
Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue. It reported the following YoY revenue for each…
On Monday, Spectrum Pharmaceuticals announced that the FDA was reportedly unable to conduct its required inspections of Spectrum’s Hanmi Bioplant due to travel restrictions related to the COVID-19 pandemic, and that as a result, the FDA was deferring action on the company’s Biologics License Application for ROLONTIS (eflapegrastim) until the…
In an effort to enhance development of medical products for orphan diseases (or rare diseases), the U.S. Food and Drug Administration announced on October 8, 2020 that it awarded six new grants for clinical trial research, including a grant for ustekinumab (STELARA®) for the prevention of graft versus host disease. …
On August 10, 2020, Equillium, Inc. announced its interim data for its study of itolizumab as a first-line treatment in patients with acute graft-versus-host disease (GVHD). GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants, and is the leading cause of non-relapse mortality…
On April 28, 2020, the U.S. Patent and Trademark Office (USPTO) issued a notice to extend certain patent and trademark deadlines to June 1, lengthening extensions that the USPTO had announced on March 31. Pursuant to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), certain deadlines between March…
Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the…