The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.

Pfizer building

In response to the ongoing Russian invasion of Ukraine, Pfizer will cease operations within Russia and proceeds from the company’s subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine. Regarding COVID-19, Pfizer Chief Executive Officer Albert Bourla noted in an interview with Face the Nation that it is likely that a fourth booster shot of the company’s vaccine will be needed to fend off another surge of infections.

Two-year follow-up data were reported from the Phase III CheckMate -9ER trial of Bristol Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib) in the first-line treatment of advanced renal cell carcinoma.

After touting positive Phase III results at the American Society of Hematology’s annual meeting, the U.S. FDA placed a clinical hold on uniQure”s hemophilia B treatment AMT-061 due to a patient developing liver cancer. 

The U.S. Food and Drug Administration approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

The U.S. Food and Drug Administration reviewed several drugs under Priority Review ahead of their PDUFA target action dates scheduled during the week of March 8th, 2020.

Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.

Cambridge, Mass.-based Dicerna Pharmaceuticals signed a research collaboration and licensing deal with Switzerland’s Roche for chronic hepatitis B virus therapies that could hit $1.67 billion.

Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.

Merck & Co. released data from KEYNOTE-181, a Phase III trial of Keytruda as a monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma.