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.`

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.