The U.S. FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
Many countries around the world that appeared to have kicked COVID-19 are reporting surges, largely the result of the so-called “stealth” Omicron variant, BA.2.
The U.S. Commerce Department added 33 Chinese entities to an “unverified list,” requiring U.S. exporters to undergo more procedures before shipping goods to the companies. WuXi Biologics was amongst those on the list, with the United States stating that it was unable to verify the legitimacy and reliability of the company’s use of U.S. exports.
Shares of Humanigen plunged in trading after the company announced the U.S. Food and Drug Administration rejected the company’s Emergency Use Authorization request for lenzilumab, a potential treatment for Covid-19.
Shares of Adaptimmune Therapeutics skyrocketed after the company announced an agreement to develop and commercialize allogeneic cell therapies for cancer with Genentech.
The U.S. Securities and Exchange Commission halted registrations of U.S. initial public offerings (IPOs) by Chinese companies.
The U.S. Supreme Court on June 21 rejected a bid by an Amarin Corp. subsidiary to revive patents on the company’s heart drug Vascepa in a legal battle against generic drugmakers Hikma Pharmaceuticals Plc and Dr. Reddy’s Laboratories Ltd.
President Joe Biden on May 5 threw his support behind waiving intellectual property rights for Covid-19 vaccines, bowing to mounting pressure from Democratic lawmakers and more than 100 other countries, but angering pharmaceutical companies. Biden voiced his support for a waiver – a sharp reversal of the previous U.S. position – in remarks to reporters, followed swiftly by a statement from his top trade negotiator, Katherine Tai, who backed negotiations at the World Trade Organization.
Amryt inked an all-stock acquisition deal with Chiasma. The combined company will focus on rare and orphan diseases with three marketed products and a strong development pipeline.
The U.S. Food and Drug Administration released a briefing document on May 4 citing concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. ChemoCentryx is seeking approval from the FDA for the drug as a therapeutic agent for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV).