Scripps reach­es $10M set­tle­ment with gov­ern­ment over al­le­ga­tions NIH grants weren't prop­er­ly ac­count­ed for

Scripps Re­search In­sti­tute has set­tled a case with the Jus­tice De­part­ment al­leg­ing claims of mis­ap­pro­pri­at­ed funds, the US at­tor­ney for the dis­trict of Mary­land an­nounced late last week.

Pros­e­cu­tors said the in­sti­tute im­prop­er­ly used NIH-fund­ed re­search grants for non-grant re­lat­ed ac­tiv­i­ties, in­clud­ing work­ing on new grant ap­pli­ca­tions, teach­ing ac­tiv­i­ties and oth­er ad­min­is­tra­tive tasks. As part of the set­tle­ment, Scripps has agreed to pay $10 mil­lion.

Pros­e­cu­tors not­ed that no de­ter­mi­na­tion of li­a­bil­i­ty had been made in the case.

“The NIH has fi­nite re­sources to sup­port im­por­tant re­search across the na­tion,” said gov­ern­ment lawyer Jef­frey Clark in a state­ment on Sept. 11. “To­day’s set­tle­ment demon­strates our com­mit­ment to pro­tect those re­sources by en­sur­ing that NIH grants funds are used for the pur­pos­es for which they were in­tend­ed.”

Ac­cord­ing to the an­nounce­ment, Scripps re­ceives mil­lions of dol­lars in NIH grant fund­ing every year, and the set­tle­ment re­solves al­le­ga­tions that oc­curred be­tween 2008 and 2016. Scripps al­leged­ly did not pro­vide a prop­er ac­count­ing sys­tem for its re­searchers to keep track of time spent on non-grant projects. As such, the in­sti­tute charged the time to the gov­ern­ment rather than al­lo­cate it as in­di­rect costs.

The al­leged in­ci­dents were orig­i­nal­ly brought to light through a whistle­blow­er claim from a for­mer Scripps em­ploy­ee, who will re­ceive $1.75 mil­lion as part of the agree­ment. While at Scripps, their salary was al­leged­ly 100% charged to the gov­ern­ment for at least two years, ac­cord­ing to re­port­ing by the Palm Beach Post. 

A spokesper­son for Scripps told End­points News that the charges stemmed from an “ac­count­ing dis­crep­an­cy that av­er­aged less than half of one per­cent per year of the in­sti­tute’s an­nu­al fed­er­al grant fund­ing.”

The in­sti­tute’s state­ment con­tin­ued:

Through­out the course of the in­quiry the In­sti­tute ful­ly co­op­er­at­ed with the fed­er­al gov­ern­ment, pro­vid­ing all re­quest­ed doc­u­men­ta­tion and as­sist­ing gov­ern­ment in­ves­ti­ga­tors. No ques­tions were raised con­cern­ing the qual­i­ty or con­duct of our re­search or the con­tri­bu­tions of our fac­ul­ty to sci­ence, in­no­va­tion, and the im­prove­ment of hu­man health.

Scripps Re­search tremen­dous­ly val­ues the in­vest­ment the fed­er­al gov­ern­ment makes in sci­en­tif­ic re­search, and we are deeply com­mit­ted to us­ing this sup­port to its ut­most to make dis­cov­er­ies and in­no­va­tions that im­prove hu­man health.

Scripps is one of the most promi­nent sci­en­tif­ic in­sti­tu­tions in the bio­med­ical are­na, with lo­ca­tions in La Jol­la, CA and Jupiter, FL. Dur­ing the Covid-19 pan­dem­ic, Scripps ex­ec­u­tive vice pres­i­dent Er­ic Topol has been one of the staunchest pro­po­nents of in­dus­try trans­paren­cy, pub­licly push­ing for vac­cine mak­ers to di­vulge in­for­ma­tion about their tri­als. Mod­er­na, Pfiz­er and As­traZeneca, the three com­pa­nies con­duct­ing Phase III stud­ies in the US, each re­leased their safe­ty blue­prints with­in the last four days.

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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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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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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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.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

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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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.