Sh­iono­gi moved a cou­ple of months ago to get in tight with a low-pro­file biotech called Tetra Ther­a­peu­tics in Grand Rapids, MI. And what­ev­er they learned about their 2 Phase II stud­ies in Alzheimer’s and Frag­ile X syn­drome per­suad­ed the phar­ma play­er to ante up to $500 mil­lion more on a buy­out.

Tues­day morn­ing, Sh­iono­gi an­nounced that it is buy­ing Tetra out­right as the biotech nav­i­gates the fi­nal stretch­es on 2 mid-stage tri­als.

Both in­di­ca­tions are in the ex­treme high-risk cat­e­go­ry, with Tetra build­ing on a se­ries of grants to test its own ap­proach on pro­tect­ing the neu­ronal con­nec­tions that play a ma­jor role in cog­ni­tion and mem­o­ry.

Their lead drug is BPN14770, which tar­gets an en­zyme that is sup­posed to mod­u­late PDE4D. Sh­iono­gi orig­i­nal­ly got in­volved with Tetra back in 2018, when ex­ecs signed up li­cens­ing rights in Asia.

In March Sh­iono­gi fol­lowed up with a deal to ex­pand its stake in Tetra to 50%, ink­ing an op­tion on the buy­out based on the read­out for the Phase II PI­CAS­SO AD study in Alzheimer’s.

The an­nounce­ment, though, is short on fi­nan­cial de­tails. That’s not too sur­pris­ing, as Sh­iono­gi is ex­pand­ing in­to a field not­ed for 10 years of fail­ure and con­tro­ver­sy. Alzheimer’s has re­sist­ed just about every­thing thrown against it, with no suc­cess in mod­u­lat­ing the dis­ease it­self. Bio­gen has at­tract­ed equal parts of praise and crit­i­cism for its own at­tempt at get­ting a drug across the fin­ish line.

We can now wait for near-term proof-of-con­cept da­ta from Sh­iono­gi, which is keep­ing the lit­tle biotech as a whol­ly-owned sub­sidiary.

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

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 in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.