Af­ter talk­ing to Trump about top FDA job, Bal­a­ji Srini­vasan erased his barbed crit­i­cism of the drug agency

Bit­coin en­tre­pre­neur and close Pe­ter Thiel as­so­ciate Bal­a­ji Srini­vasan has long en­joyed tak­ing to Twit­ter to poke the FDA for be­ing too slow at ap­prov­ing new ther­a­pies. By his ac­count, the agency was guilty of con­sid­er­able harm. But late Fri­day night, af­ter news of his meet­ing on Thurs­day with Don­ald Trump for a top job at the agency spread like dig­i­tal wild­fire, his Twit­ter stream and FDA com­men­tary all dis­ap­peared in the blink of an eye.

Now there’s just one re­mark on dis­play.

 

You can still find sam­ples of his thoughts from re­porters pre­scient enough to grab them. Don­na Young at S&P Glob­al cit­ed these on Fri­day:

  • “For every thalido­mide though, many dead from slowed ap­provals.”
  • “Be­fore the FDA, sci­en­tists were able to take in­sulin from bench to bed­side in two years.”

This one could come­back to haunt him:

https://twit­ter.com/christapeter­so/sta­tus/820382547490193409

Srini­vasan may not have want­ed all of his tweets to come back for pub­lic dis­cus­sion if Trump breaks with tra­di­tion and goes with a new com­mis­sion­er who is not a doc­tor. Up to now, the smart mon­ey in bio­phar­ma cir­cles had fo­cused on Scott Got­tlieb, who is a physi­cian and has staked out an ac­tivist Re­pub­li­can per­spec­tive on Twit­ter and through nu­mer­ous op-ed pieces.

Srini­vasan is al­so close to Jim O’Neill, an­oth­er Thiel col­league and FDA con­tender who fa­mous­ly said at one time that the FDA should al­low drugs to be mar­ket­ed once they had es­tab­lished their safe­ty, let­ting ef­fi­ca­cy get worked out among the pa­tients. And Thiel him­self, as Young al­so re­port­ed, has been crit­i­cal of the FDA for not be­ing more en­cour­ag­ing to an­ti-ag­ing re­search.

All three, Srini­vasan, O’Neill and Thiel, have backed seast­eading, a fringe ef­fort aimed at sup­port­ing the de­vel­op­ment of in­de­pen­dent com­mu­ni­ties at sea — far from any gov­ern­ment over­sight and bu­reau­crat­ic en­tan­gle­ments.

One of them may get to see how the same at­ti­tude could play out with the au­thor­i­ty to run the FDA.

Trump him­self re­mains a reg­u­lar on Twit­ter, hap­py to stake out some con­tro­ver­sial po­si­tions. He’s al­ready made it clear that he in­tends to get drugs through the ap­proval process faster. And as of last week’s press con­fer­ence, you can add an out­spo­ken po­si­tion on us­ing the fed­er­al gov­ern­ment to rein in drug prices af­ter phar­ma com­pa­nies got “away with mur­der.”

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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UP­DAT­ED: In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

Update: An earlier version of this article misidentified the jailed Insys CEO. Former CEO John Kapoor was sentenced to 5.5 years in prison in January. Endpoints News regrets the error.

The Justice Department’s years-long battle with Indivior has arrived at a rare place: the jailing of a pharmaceutical executive.

A US district court sentenced long-running Indivior CEO Shaun Thaxter to 6 months in federal prison for his role in company efforts to mislead a major healthcare provider about the safety and abusability of their opioid addiction drug Suboxone, which generated billions in revenue over the last decade. Thaxter joins former Insys CEO John Kapoor as one of the only two executives to face prison time for their roles in the opioid epidemic.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.