President Joe Biden (AP Images)

How will the Biden ad­min­is­tra­tion af­fect fund­ing for life sci­ence re­search?

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The ad­vent of a new ad­min­is­tra­tion in Wash­ing­ton of­ten por­tends ma­jor changes in bud­get­ing and spend­ing, and thus it will be in the ad­min­is­tra­tion of Joe Biden, if he ad­heres to the 2020 De­mo­c­ra­t­ic Par­ty plat­form.

But one thing that is not like­ly to change is the on­go­ing uptick in fund­ing for re­search in the life sci­ences — par­tic­u­lar­ly the fund­ing for the Na­tion­al In­sti­tutes of Health, the Cen­ters for Dis­ease Con­trol, and oth­er fed­er­al agen­cies fo­cused on life sci­ence re­search.

The rea­son for that is sim­ple: Covid-19 is still with us, and based on re­cent num­bers, it shows no sign of leav­ing any­time soon — de­spite the de­vel­op­ment of vac­cines by Pfiz­er, Mod­er­na, and oth­er phar­ma­ceu­ti­cal com­pa­nies. In a speech on the week­end pri­or to his in­au­gu­ra­tion, Biden said that it was his goal “to help re­store faith in Amer­i­ca’s place in the fron­tier of sci­ence and dis­cov­ery.” Sci­ence, he added, “is dis­cov­ery … it’s about hope.”

And while politi­cians — whether they be city coun­cil mem­bers or pres­i­dents — are known for their hy­per­bol­ic de­c­la­ra­tions that don’t al­ways lead some­where, Biden is not an un­known quan­ti­ty. As a mem­ber of the Sen­ate for decades, he has an eas­i­ly-ex­am­ined record on mat­ters of all kinds, in­clud­ing life sci­ence fund­ing and re­search.

Ac­cord­ing to med­ical jour­nal The Lancet, Biden “has had a long-stand­ing in­ter­est in med­ical re­search.” As Vice Pres­i­dent un­der Barack Oba­ma, he was in charge of the ad­min­is­tra­tion’s Can­cer Moon­shot Task Force, which “brought a new ur­gency to the Fed­er­al gov­ern­ment ef­forts to fight can­cer, and forged new part­ner­ships and cre­at­ed new pro­grams and poli­cies.” A re­port is­sued at the end of the ad­min­is­tra­tion’s term shows that sig­nif­i­cant progress was made in mar­shal­ing re­sources, both pub­lic and pri­vate, to “achieve a decade’s worth of progress in five years” in the fight against can­cer.

With a pan­dem­ic still rag­ing, Biden has pledged to bring the same com­mit­ment to fight­ing Covid-19 — in which he promis­es “a de­ci­sive pub­lic health re­sponse” that in­cludes de­vel­op­ment of vac­cines, fund­ing for its dis­tri­b­u­tion, and “the full de­ploy­ment and op­er­a­tion of nec­es­sary sup­plies, per­son­nel, and fa­cil­i­ties.”

If Biden does in­deed in­crease bud­gets for life sci­ence re­search, he will be fol­low­ing in a decades-strong tra­di­tion. The bud­get for the NIH, for ex­am­ple, has near­ly quadru­pled since 1995, grow­ing every year, in­clud­ing in 2021; in its bud­get for this year, Con­gress ap­proved a 3% in­crease in the agency’s fund­ing, with the to­tal al­lo­ca­tion for the year at $42.9 bil­lion, $1.25 bil­lion more than the 2020 lev­el.

Last year, the NIH award­ed 10 grants for the es­tab­lish­ment of the first-ever Cen­ters for Re­search in Emerg­ing In­fec­tious Dis­eases (CREID), a “glob­al net­work will in­volve mul­ti­dis­ci­pli­nary in­ves­ti­ga­tions in­to how and where virus­es and oth­er pathogens emerge from wildlife and spillover to cause dis­ease in peo­ple.”

That ini­tia­tive is a sign of things to come; the Covid-19 pan­dem­ic has raised con­cerns among sci­en­tists that hu­man­i­ty could see a rise in zoonot­ic dis­eases, re­sult­ing in even greater pub­lic health threats in the years to come.

One of the lessons of the pan­dem­ic is that we can­not rest on our lau­rels when it comes to health­care re­search. Along with pre­vent­ing pan­demics, the NIH will con­tin­ue fund­ing the many oth­er ar­eas in which it is ac­tive, in­clud­ing can­cer re­search, ar­ti­fi­cial in­tel­li­gence, Alzheimer’s treat­ment, etc. That fund­ing will go to uni­ver­si­ties, star­tups, phar­ma­ceu­ti­cal firms, and oth­er or­ga­ni­za­tions that are do­ing deep-dive re­search in all these ar­eas.

While much of that fund­ing goes to aca­d­e­m­ic re­search, the NIH pro­vides bil­lions of dol­lars an­nu­al­ly for small life sci­ence re­search firms, who are at the fore­front of de­vel­op­ing sci­en­tif­ic ini­tia­tives in­to prod­ucts and ser­vices that will help solve some of our most press­ing health prob­lems.

In fact, it was such non-di­lu­tive gov­ern­ment fund­ing that en­abled the phar­ma­ceu­ti­cal firms to quick­ly de­vel­op the Covid-19 vac­cines, based on the use of mR­NA tech­nol­o­gy to en­able the de­vel­op­ment of an­ti­bod­ies to the virus. That tech­nol­o­gy has been around for years, based on re­search con­duct­ed by small and start­up biotech firms and labs stretch­ing back decades.

An­oth­er les­son learned from Covid-19: Lis­ten to the sci­ence. The vac­cines are the re­sult of years of re­search and ex­ten­sive col­lab­o­ra­tion be­tween sci­en­tists all over the world, and that col­lab­o­ra­tion suc­ceed­ed. If that ap­proach was able to bring a so­lu­tion to one of the biggest prob­lems we’ve faced in mod­ern times, it can help solve many oth­er prob­lems, too — and there is no doubt that the new ad­min­is­tra­tion will ap­ply that Covid-in­duced les­son to oth­er prob­lems, too.

Ram May-Ron is a man­ag­ing part­ner at Free­Mind.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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