Targeted failure of the week. Post No 63 and 64. Tofacitinib and NIH's National Institute of Allergy and Infectious Diseases

Let'a start from API: the case is classical, drug is toxic and inefficient:

Pfizer Inc. (NYSE:PFE) said EMA's CHMP recommended against approval of an MAA for Xeljanz tofacitinib to treat moderate to severe rheumatoid arthritis. According to Pfizer, the committee said that while Xeljanz improved the signs and symptoms of RA and patients' physical functions, CHMP "did not believe that a consistent reduction in disease activity and structural damage had been sufficiently demonstrated." The pharma said the committee also expressed concern about serious infections, gastrointestinal perforations and malignancies in clinical trials of the oral pan-Janus kinase (JAK) inhibitor.

And then we have also very typical failure when big national institution fails:

 

NIH's National Institute of Allergy and Infectious Diseases (NIAID) discontinued the Phase IIb HVTN 505 trial to prevent HIV infection after an interim analysis showed a lack of efficacy of the vaccine regimen in the trial. An independent DSMB found that the VRC DNA/rAd5 HIV vaccine regimen -- which consists of an HIV-1 DNA plasmid vaccine injection on days 1, 28 and 56 followed by a recombinant adenovirus serotype 5 (rAd5) vector vaccine injection on day 168 -- did not prevent HIV infection nor reduce viral load in vaccine recipients who became infected with HIV. The double-blind, placebo-controlled, U.S. trial enrolled 2,504 HIV-uninfected circumcised men who have sex with men and transgender people who have sex with men. All subjects received HIV risk-reduction counseling and condoms.

NIAID said it will work to analyze the data to better understand why the vaccine regimen did not work and to guide future vaccine development efforts. The vaccine regimen was developed by NIAID's Vaccine Research Center and the trial was conducted by the HIV Vaccine Trials Network (HVTN), which is funded by NIAID.