Last-minute US spend­ing bill fea­tures a be­gin­ning for ARPA-H, and half of what Biden re­quest­ed for Covid-19

The House and Sen­ate are again rac­ing against the clock to pass an an­nu­al $1.5 tril­lion gov­ern­ment spend­ing bill, with a tight dead­line Fri­day that may have to be briefly ex­tend­ed to ear­ly next week.

Un­der the 2,700+ page bill for 2022, re­leased just af­ter mid­night on Wednes­day, fund­ing for Covid-re­lat­ed pro­vi­sions will on­ly hit $15.6 bil­lion af­ter the Biden ad­min­is­tra­tion pre­vi­ous­ly re­quest­ed about $30 bil­lion to help pre­pare for the next wave of cas­es.

That to­tal in­cludes al­most $10 bil­lion for BAR­DA to buy more oral Covid-19 an­tivi­rals, mon­o­clon­al an­ti­bod­ies and vac­cines, which will be cru­cial to ramp up sup­plies, par­tic­u­lar­ly for Pfiz­er’s pill. Al­though the US has pur­chased a to­tal of 10 mil­lion cours­es of Pfiz­er’s an­tivi­ral Paxlovid, on­ly about 690,000 cours­es have al­ready been dis­trib­uted, and on­ly about 100,000 more cours­es have so far been pro­cured to date.

An ad­di­tion­al $750 mil­lion in 2022 funds will go to­ward de­vel­op­ing vac­cines that pro­tect against fu­ture vari­ants. Who will re­ceive those funds re­mains un­known. And an­oth­er near­ly $4.5 bil­lion will go to an ini­tia­tive to in­crease glob­al vac­ci­na­tions over­seas, with an aim for a 70% vac­ci­na­tion rate in every coun­try.

Mean­while, the spend­ing bill, which is ex­pect­ed to clear Con­gress and be signed by Biden, al­so in­cludes $1 bil­lion to kick-start Biden’s new­ly pro­posed Ad­vanced Re­search Pro­jects Agency for Health or ARPA-H. Biden had ini­tial­ly re­quest­ed $6.5 bil­lion for the NIH-housed re­search out­fit, which is go­ing to mir­ror DARPA with risky, ground­break­ing in­vest­ments.

ARPA-H’s in­vest­ments in­to var­i­ous re­search en­deav­ors may in­clude can­cer vac­cine de­vel­op­ment, or even ways to make man­u­fac­tur­ing process­es for pa­tient-spe­cif­ic T cells cheap­er and eas­i­er.

Mean­while, the De­part­ment of De­fense is al­so dol­ing out $577.5 mil­lion for can­cer re­search in 2022, on top of the Na­tion­al Can­cer In­sti­tute’s $6.7 bil­lion bud­get. The DoD funds in­clude $150 mil­lion for breast can­cer re­search and $110 mil­lion for prostate can­cer re­search.

The FDA will re­ceive a to­tal of $3.3 bil­lion in dis­cre­tionary fund­ing from the bill for 2022, which is a slight in­crease of $102 mil­lion above the FY 2021 en­act­ed lev­el. But the ap­pro­pri­a­tions from Con­gress make up a lit­tle more than half of all to­tal fund­ing for FDA, which al­so gets $2.9 bil­lion in in­dus­try user fees next year.

With­in this 2022 to­tal, the House Ap­pro­pri­a­tions Com­mit­tee pro­vides a tar­get­ed in­crease of $29 mil­lion at FDA to ad­dress the opi­oid cri­sis, med­ical sup­ply chain sur­veil­lance, rare can­cers, and in­creas­ing and strength­en­ing in-per­son in­spec­tions of for­eign drug man­u­fac­tur­ers, the ap­pro­pri­a­tions com­mit­tee said.

No less than $8.5 mil­lion is set aside in the FDA’s bud­get for pi­lot projects to in­crease unan­nounced for­eign drug in­spec­tions.

Mem­bers on both sides of the aisle have crit­i­cized the FDA for not con­duct­ing more unan­nounced in­spec­tions over­seas (where­as FDA of­ten in­spects do­mes­tic fa­cil­i­ties unan­nounced) al­though FDA of­fi­cials have ex­plained that if the ap­pro­pri­ate of­fi­cials are not at the for­eign site when the FDA in­spec­tors show up unan­nounced, the agency can waste re­sources on or­ga­niz­ing such in­spec­tions.

The bill al­so ap­pro­pri­ates $50 mil­lion to ac­cel­er­ate med­ical prod­uct de­vel­op­ment as au­tho­rized in the 21st Cen­tu­ry Cures Act.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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