Critical comments of the drug evaluation process bring about strong reaction from industry.
In a recent analytical article and additional commentary published in BMJ, the drug evaluation process suffered heavy criticism. The controversial articles-which can be found below-elicited strong reactions from industry leaders including, Dr. Beat Widler, Professor Gerfried Nell, Dr. Uwe Gudat, and Thorsten Ruppert. Continue reading to hear clinical trials professionals defend and discuss the depictions made in the BMJ publications.
“Patients and the public deserve big changes in evaluation of drugs,” Silvio Garattini, director, Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa 19, 20156 Milan, Italy; and Iain Chalmers, editor, James Lind Library, 2 Summertown Pavilion, Oxford OX2 7LG, U.K.
"
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.
Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
March 19th 2024Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.