Rick Bright arrives to testify before the House Energy and Commerce Subcommittee on Health on May 14, 2020 (Greg Nash, POOL/AFP via Getty Images)

BAR­DA chief turned whistle­blow­er Rick Bright re­signs from gov­ern­ment with one last broad­side against the Trump ad­min­is­tra­tion

Rick Bright, the fed­er­al vac­cines of­fi­cial turned whistle­blow­er, re­signed from the gov­ern­ment yes­ter­day, fir­ing a fi­nal charge of po­lit­i­cal med­dling at the Trump Ad­min­is­tra­tion as he de­part­ed.

Bright had led BAR­DA for 4 years be­fore be­ing sud­den­ly re­moved from the post in April, just as the once lit­tle-known agency was gear­ing up for what would ul­ti­mate­ly be a more than $10 bil­lion ef­fort to ac­cel­er­ate vac­cines and ther­a­peu­tics for one of the worst pan­demics in mod­ern his­to­ry. In sub­se­quent state­ments, whistle­blow­er com­plaints, and con­gres­sion­al tes­ti­mo­ny, he al­leged that he was oust­ed for re­sist­ing a plan to mass dis­trib­ute hy­drox­y­chloro­quine — a Trump-tout­ed drug that has since re­peat­ed­ly proven in­ef­fec­tive — to hard-hit ar­eas and de­scribed an ex­tend­ed his­to­ry of po­lit­i­cal in­ter­fer­ence in agency de­ci­sion-mak­ing.

The Trump Ad­min­is­tra­tion said at the time they would place Bright at the NIH, where he would help lead Covid-19 di­ag­nos­tic ef­forts. But in an amend­ed whistle­blow­er com­plaint, Bright said that he was stymied in those ef­forts by po­lit­i­cal con­cerns and had been “giv­en no mean­ing­ful work” since he com­plet­ed that job on Sept. 4.

“Dr. Bright was forced to leave his po­si­tion at NIH be­cause he can no longer sit idly by and work for an ad­min­is­tra­tion that ig­nores sci­en­tif­ic ex­per­tise, over­rules pub­lic health guid­ance and dis­re­spects ca­reer sci­en­tists, re­sult­ing in the sick­ness and death of hun­dreds of thou­sands of Amer­i­cans,” Bright’s at­tor­neys, De­bra Katz and Lisa Bank, said in a state­ment. “NIH lead­er­ship de­clined to sup­port Dr. Bright’s rec­om­men­da­tions be­cause of po­lit­i­cal con­sid­er­a­tions, plain and sim­ple.”

Bright said he was tasked to help lead the NIH’s RADx ini­tia­tive to scale up new Covid-19 di­ag­nos­tics. He said he com­plet­ed that work and pro­posed a plan that would have helped set up a na­tion­al test­ing in­fra­struc­ture in­volv­ing large amounts of 24-hour, point-of-care tests in hos­pi­tals, schools and nurs­ing homes and low-cost, home-based tests — a set of rec­om­men­da­tions that out­side pub­lic health ex­perts have re­peat­ed­ly called for.

Fran­cis Collins

NIH Di­rec­tor Fran­cis Collins re­ject­ed these rec­om­men­da­tions, Bright said, out of con­cern the Trump Ad­min­is­tra­tion wouldn’t ac­cept broad-based test­ing and that it might step on the toes of work with­in HHS.

“While Dr. Collins’s timid­i­ty to push Dr. Bright’s plan for­ward is un­der­stand­able giv­en the per­va­sive fear with­in HHS and among ca­reer sci­en­tists,” the amend­ed com­plaint says, “Dr. Bright was aghast that Dr. Collins re­fused to sup­port the im­ple­men­ta­tion of an ag­gres­sive and co­her­ent na­tion­al test­ing strat­e­gy be­cause of po­lit­i­cal con­sid­er­a­tions and fear of the Ad­min­is­tra­tion’s re­sponse.”

Bright said he re­quest­ed to work on Covid-19 vac­cines and ther­a­peu­tics un­der Op­er­a­tion Warp Speed in Sep­tem­ber af­ter com­plet­ing the NIH work but re­ceived no re­sponse.

The amend­ed com­plaint al­so dis­closed that Bright dealt with an ag­gres­sive skin can­cer over the sum­mer and re­quired a se­ries of surg­eries and chemother­a­py treat­ments.

The Of­fice of Spe­cial Coun­sel has rec­om­mend­ed Bright be re­in­stat­ed as BAR­DA chief pend­ing com­ple­tion of an in­ves­ti­ga­tion. The White House has ig­nored that rec­om­men­da­tion.`

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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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.

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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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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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.

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.