Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When for­mer Pres­i­dent Don­ald J. Trump was vot­ed out of of­fice Nov. 2, his gung-ho ef­fort to “on­shore” drug man­u­fac­tur­ing was left most­ly up in the air. Joe Biden has been most­ly mum on whether he would con­tin­ue that ef­fort, but a new ex­ec­u­tive or­der could pro­vide a clue — at least in a few months.

In an or­der signed Wednes­day, Biden de­mand­ed a 100-day gov­ern­men­tal re­view of key sup­ply chains, in­clud­ing for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) used in Amer­i­can drugs.

Biden’s ef­fort doesn’t amount to full-scale ef­fort launched un­der the Trump ad­min­is­tra­tion to in­fuse bil­lions in­to Amer­i­can-made drug man­u­fac­tur­ers, but a key note in the pres­i­dent’s pre­pared fact sheet could in­di­cate his goal. In that doc­u­ment, his team high­light­ed that 70% of US API pro­duc­ers had moved off­shore in re­cent decades — po­ten­tial­ly threat­en­ing the sup­ply of a sta­ble sup­ply chain dur­ing fu­ture pan­demics.

Since his in­au­gu­ra­tion, it’s been un­clear whether Biden would adopt the ex­plic­it na­tivist tone of Trump’s “Buy Amer­i­ca” ini­tia­tive, which cul­mi­nat­ed in an Au­gust ex­ec­u­tive or­der aim­ing to dri­ve new in­vest­ment in on­shore drug pro­duc­tion.

That game plan some­times led to a few ques­tion­able in­vest­ments, most no­tably a $765 mil­lion loan through the ad­min­is­tra­tion’s de­vel­op­ment fi­nance arm to cam­era mak­er Ko­dak. Af­ter the loan was an­nounced, ac­cu­sa­tions of in­sid­er trad­ing and an SEC in­ves­ti­ga­tion even­tu­al­ly sent that ini­tia­tive in­to a tail­spin in Au­gust.

Mean­while, the gov­ern­ment made a more di­rect in­vest­ment in the up­start Phlow Cor­po­ra­tion in May, a pre­vi­ous­ly un­known com­pa­ny that was tapped to part­ner with gener­ics mak­er Civi­ca Rx, among oth­ers, to build a Vir­ginia plant for crit­i­cal hos­pi­tal drugs. In Jan­u­ary, Civi­ca an­nounced it would dole out $124.5 mil­lion to build its first in-house man­u­fac­tur­ing op­er­a­tion in Pe­ters­burg, Vir­ginia — close to Phlow and the oth­er part­ners in the gov­ern­ment con­tract, Med­i­cines for All In­sti­tute and AM­PAC Fine Chem­i­cals.

Out­side the gov­ern­ment’s purview, oth­er big-name play­ers have stepped up in re­cent months to put their own big down pay­ments on Amer­i­can-made drugs.

In Jan­u­ary, bil­lion­aire in­vestor Mark Cuban put his name to a new com­pa­ny dubbed Mark Cuban Cost Plus Drugs, a gener­ics start­up us­ing flat-rate mar­gins at whole­sale to dri­ve down the cost of ex­pen­sive gener­ics. The goal is even­tu­al­ly to launch more than 100 drugs on­to the mar­ket by the end of this year, but the firm will start with an­tipar­a­sitic al­ben­da­zole, which it says it will of­fer at an av­er­age price per tablet of $20 com­pared with the cur­rent av­er­age of $225 MSRP. For in­sured pa­tients, that price could go “as low as a dol­lar,” the com­pa­ny said on its web­site.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.