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.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

De­nali un­veils new way of cross­ing blood brain bar­ri­er as the big neu­ro­science bet en­ters its clin­i­cal years

Five years ago, as much of pharma began leaving neuroscience, three big-name scientists from Genentech and some A-list investors, including ARCH and Flagship, made a $217 million bet that new genetic insights and a reliance on biomarkers could bring them success. They called it Denali Therapeutics.

Still, Denali faced the problem that neuroscience developers have faced for decades: How do you get a large molecule across the blood-brain barrier, a natural defense evolved precisely to keep them out? Enzyme replacement therapy, for instance, would be a great candidate to treat several neurological disorders, but enzymes can’t cross the barrier.