De­men­tia Dis­cov­ery Fund clos­es $350M, re­cruits Cel­gene ex­ec as CEO; Ex-Lazard banker Ian Woo joins C-Bridge and Ever­est

→ With a fresh $60 mil­lion in­vest­ment from US AARP, the De­men­tia Dis­cov­ery Fund has of­fi­cial­ly closed its $350 mil­lion fundrais­ing round. The to­tal sur­passed the group’s ini­tial tar­get of $200 mil­lion. The DDF says it’s the first and largest fund ded­i­cat­ed to de­men­tia, in­clud­ing Alzheimer’s dis­ease. The fund is man­aged by SV Health and was formed with col­lab­o­ra­tion from Bio­gen, Eli Lil­ly, GSK, J&J, Ot­su­ka (As­tex), Pfiz­er and Take­da, the UK De­part­ment of Health and So­cial Care and the char­i­ty Alzheimer’s Re­search UK. Since the group’s launch in 2015, its made 16 in­vest­ments.

With its fresh in­fu­sion of cash, the DDF al­so an­nounced a new CEO in An­gus Grant, the for­mer cor­po­rate vice pres­i­dent of busi­ness de­vel­op­ment at Cel­gene.

“An­gus has a huge amount of ex­pe­ri­ence in iden­ti­fy­ing, de­vel­op­ing, fund­ing, reg­u­lat­ing and deal mak­ing with nov­el ther­a­pies in­ter­na­tion­al­ly and we look for­ward to the sig­nif­i­cant guid­ance and ex­per­tise that he will bring,” said Kate Bing­ham, man­ag­ing part­ner at SV Health In­vestors, in a state­ment.

C-Bridge Cap­i­tal has re­cruit­ed Ian Woo, a man­ag­ing di­rec­tor of glob­al health­care group Lazard, to serve as the com­pa­ny’s man­ag­ing di­rec­tor. Woo will al­so serve as pres­i­dent and CEO of Ever­est Med­i­cines, one of C-Bridge’s port­fo­lio com­pa­nies. “Ian has a proven track record of man­ag­ing cross-bor­der trans­ac­tions,” said Fu Wei, CEO of C-Bridge Cap­i­tal, in a state­ment. “As part of our team, he will help lead the ac­cel­er­a­tion of Ever­est’s li­cens­ing and de­vel­op­ment ef­forts for bio­phar­ma­ceu­ti­cal as­sets from the U.S. and Eu­rope for com­mer­cial­iza­tion in Chi­na and neigh­bor­ing Asian mar­kets.”

Jar­diance, the SGLT2 drug ap­proved for Type 2 di­a­betes has now come through on two stud­ies in­volv­ing Type 1 pa­tients. Eli Lil­ly $LLY and Boehringer say they’ll now ex­plore their reg­u­la­to­ry op­tions, stop­ping short of say­ing they’ll file for an OK.

Ver­tex $VRTX has long had a hard time con­vinc­ing sin­gle pay­ers in Eu­rope to pay up for their cys­tic fi­bro­sis drug Orkam­bi. Now New York state of­fi­cials are get­ting in­to the act, say­ing the cost of this drug just doesn’t mea­sure up to the lim­it­ed ef­fi­ca­cy. 

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

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.”

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

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.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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News brief­ing: HHS chas­tis­es Eli Lil­ly for end­ing some dis­counts in a pan­dem­ic; Gilead to pay $97 mil­lion to set­tle kick­back al­le­ga­tions

Gilead agreed to pay $97 million to settle allegations that it illegally used a charity to pay thousands of Medicare patients’ co-payments for its pulmonary arterial hypertension drug Letairis.

The US government claimed that between June 2007 and December 2010, Gilead $GILD used the Caring Voice Coalition as a conduit to cover the costs of just its own drug. The alleged behavior goes against the False Claims Act.

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

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.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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