Take­da has stum­bled again in its quest to build up the block­buster po­ten­tial of its mul­ti­ple myelo­ma drug Nin­laro. The phar­ma gi­ant says the drug com­bined with dex­am­etha­sone failed to pro­vide sig­nif­i­cant help for pa­tients with rare cas­es of sys­temic light-chain amy­loi­do­sis, so now they’re scrap­ping the en­tire Phase III pro­gram.

Philip Row­lands LinkedIn

The drug failed on the first pri­ma­ry end­point on hema­to­log­i­cal re­spons­es, and re­searchers are throw­ing in the tow­el on or­gan de­te­ri­o­ra­tion and death, the sec­ond pri­ma­ry end­point, with lit­tle ex­pec­ta­tion of suc­cess. The drug com­bo with dex was com­pared against a physi­cian’s choice se­lec­tion of dex­am­etha­sone plus ei­ther mel­pha­lan, cy­clophos­phamide, thalido­mide, or lenalido­mide; or dex­am­etha­sone alone.

We won’t have the num­bers un­til a lat­er sci­en­tif­ic con­fer­ence, but Take­da on­col­o­gy chief Phil Row­lands said the tri­al was “one of the largest” mount­ed in this field. Pa­tients suf­fer­ing from amy­loi­do­sis ex­pe­ri­ence an ac­cu­mu­la­tion of amy­loid in or­gans, which can trig­ger even­tu­al or­gan fail­ure. 

Take­da has had high hopes for Nin­laro since its ap­proval in 2015. But it al­so faces sig­nif­i­cant com­pe­ti­tion with a grow­ing va­ri­ety of drugs in the same mar­ket.

This lat­est set­back on Nin­laro comes fast on the heels of an­oth­er stum­ble ear­li­er in the year, when the com­pa­ny said that it was with­draw­ing their ap­pli­ca­tion to sell the drug as a main­te­nance ther­a­py for myelo­ma pa­tients af­ter stem cell trans­plants. Take­da had pur­sued that  in­di­ca­tion with pos­i­tive pro­gres­sion-free sur­vival stats, but the agency is hold­ing out for over­all sur­vival da­ta be­fore they con­sid­er a green light.

So­cial im­age: Take­da

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.