In a blow to sci­ence, Trump ad­min­is­tra­tion aborts fed­er­al fund­ing for fe­tal tis­sue re­search

The Trump ad­min­is­tra­tion’s os­si­fied stance on re­pro­duc­tive rights is now set to in­ter­rupt sci­en­tif­ic re­search. On Wednes­day, med­ical re­search fund­ing for NIH sci­en­tists us­ing fe­tal tis­sue was abort­ed, along with a mul­ti­mil­lion-dol­lar con­tract with the Uni­ver­si­ty of Cal­i­for­nia that in­volves re­search us­ing fe­tal tis­sue de­rived from elec­tive abor­tions to test HIV ther­a­pies.

Fe­tal tis­sue, har­vest­ed from dead fe­tus­es — from in­duced or nat­ur­al abor­tions — is used as trans­plan­ta­tion ma­te­r­i­al or to cre­ate cell lines. These cell lines can be uti­lized to test a drug’s abil­i­ty to dam­age ge­net­ic ma­te­r­i­al or to test the ef­fects of spe­cif­ic vi­ral (or oth­er types) of in­fec­tion. Since fe­tal cells mul­ti­ply — a small num­ber de­rived from a dead fe­tus can be eas­i­ly ex­pand­ed and used ei­ther as a source of more cell lines or for trans­plants.

Sci­en­tists have long un­der­scored the sig­nif­i­cance of us­ing fe­tal tis­sue for re­search. It has aid­ed the de­vel­op­ment of vac­cines for dis­eases that once rav­aged com­mu­ni­ties glob­al­ly — in­clud­ing Po­lio, rubel­la, measles, chick­en­pox and ra­bies. On­go­ing re­search has al­so har­nessed fe­tal tis­sue for a pletho­ra of ther­a­peu­tic fields, such as di­a­betes, cer­tain blood dis­or­ders, ra­di­a­tion poi­son­ing, and var­i­ous neu­ro­log­i­cal dis­or­ders.

In a de­cid­ed win for an­ti-abor­tion ac­tivists that form a core of Pres­i­dent Trump’s vot­er base — the HHS on Wednes­day in its state­ment an­nounc­ing the fed­er­al re­search ban not­ed that “(p)ro­mot­ing the dig­ni­ty of hu­man life from con­cep­tion to nat­ur­al death is one of the very top pri­or­i­ties of Pres­i­dent Trump’s ad­min­is­tra­tion.”

The move re­flects the stance of the White House, in par­tic­u­lar, vice pres­i­dent Mike Pence, on abor­tion and women’s rights: it fol­lows a raft of re­cent de­ci­sions de­signed to thwart women from mak­ing de­ci­sions about their own bod­ies — from black­balling Planned Par­ent­hood and sim­i­lar or­ga­ni­za­tions to en­hanc­ing pro­tec­tions for health­care providers that refuse to en­dorse abor­tion on moral/re­li­gious grounds. It is al­so re­flec­tive of the Trump ad­min­is­tra­tion’s at­ti­tude of di­min­ish­ing — if not out­right ig­nor­ing — sci­en­tif­ic re­search in pol­i­cy.

Fran­cis Collins NIH

Af­ter the HHS — un­der the aus­pices of the Trump ad­min­is­tra­tion — be­gan to scru­ti­nize fed­er­al­ly-fund­ed fe­tal tis­sue re­search last year, NIH di­rec­tor Fran­cis Collins cham­pi­oned the use of the ma­te­r­i­al, as­sert­ing it was “sci­en­tif­i­cal­ly and eth­i­cal­ly jus­ti­fied” at a meet­ing of an agency ad­vi­so­ry pan­el.

Sci­en­tists came out in droves to reg­is­ter their frus­tra­tion with the HHS an­nounce­ment.

“These new re­stric­tions have no sci­en­tif­ic or eth­i­cal ba­sis and will roll back decades of con­sen­sus in the U.S., de­lay­ing the de­vel­op­ment of new med­ical treat­ments…With these new ar­bi­trary re­stric­tions on re­search, the Unit­ed States is ced­ing its role as the glob­al leader in the de­vel­op­ment of cel­lu­lar ther­a­pies and re­gen­er­a­tive med­i­cine. Amer­i­cans will now wait for life-sav­ing ther­a­pies to be de­vel­oped in Eu­rope, Asia, and oth­er parts of the world,” said Doug Melton, pres­i­dent of the In­ter­na­tion­al So­ci­ety for Stem Cell Re­search (ISS­CR), a large or­ga­ni­za­tion rep­re­sent­ing stem cell re­searchers across the world.

De­mo­c­rat law­mak­ers were al­so aghast.

Frank Pal­lone, Jr Twit­ter

“(T)he Trump Ad­min­is­tra­tion once again places ide­ol­o­gy over sci­ence and facts…It’s im­por­tant that re­searchers are not ham­strung by ar­bi­trary lim­its on where the sci­ence can take them. The Ad­min­is­tra­tion should be spend­ing its time sup­port­ing and in­vest­ing in life­sav­ing med­ical re­search rather than un­der­min­ing sci­en­tif­ic in­quiry for po­lit­i­cal rea­sons,” said En­er­gy and Com­merce Chair­man Frank Pal­lone, Jr in a state­ment.

Last De­cem­ber, the NIH was giv­en $20 mil­lion for re­search to de­vel­op, demon­strate, and val­i­date ex­per­i­men­tal mod­els that do not re­ly on hu­man fe­tal tis­sue from elec­tive abor­tions.


Im­age: NIH via Flickr.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,500+ biopharma pros reading Endpoints daily — and it's free.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,500+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
Endpoints News

Basic subscription required

Unlock this story instantly and join 57,500+ biopharma pros reading Endpoints daily — and it's free.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,500+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.