Just a few months af­ter phar­ma gi­ant No­var­tis part­nered up with Sci­ence 37 on its vir­tu­al ap­proach to clin­i­cal tri­al work, Re­code re­ports that the would-be CRO dis­rup­tor is in talks with Soft­Bank ex­ecs on a $150 mil­lion in­vest­ment.

Noah Craft, Sci­ence 37 CEO

Soft­Bank, which pro­vid­ed Roivant chief Vivek Ra­maswamy with more than a bil­lion dol­lars to in­vest in biotech, ev­i­dent­ly has been drawn to Sci­ence 37’s promise that it can ef­fi­cient­ly and ef­fec­tive­ly re­cruit pa­tients for clin­i­cal tri­als with­out forc­ing them in­to a tri­al site. Us­ing new telemed­i­cine tech, they say they can ac­cu­mu­late clean datasets to show whether or not new drugs are work­ing — hop­ing to dis­rupt the big play­ers who now dom­i­nate the CRO world.

Quot­ing sources, Re­code notes that Sci­ence 37 is plan­ning to val­ue it­self at $300 mil­lion for this deal, up about $100 mil­lion since Lux Cap­i­tal and Google’s GV helped back the com­pa­ny a lit­tle more than a year ago. 

Soft­Bank’s big, $98 bil­lion Vi­sion Fund has made re­peat­ed for­ays in­to the world of drug de­vel­op­ment and tech­nol­o­gy. Aside from Roivant, the group par­tic­i­pat­ed in the mas­sive $500 mil­lion round to back George Scan­gos’ Vir, which is work­ing on an in­fec­tious dis­ease drug pipeline.

The CRO busi­ness has un­der­gone a decade of shak­ing out as pri­vate eq­ui­ty groups moved in to buy up the out­sourc­ing com­pa­nies and meld them in­to a set of large and ag­gres­sive glob­al play­ers, of­ten with big staffs. Shak­ing them up with a new tech ap­proach won’t come eas­i­ly in an R&D world where safe and de­pend­able are key watch­words in the high-risk world of drug de­vel­op­ment.

But Sci­ence 37 con­tin­ues to build up a head of steam to give it a try.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.