With four days left in the fis­cal year, FDA-re­lat­ed pol­i­cy rid­ers ap­proved in both House and Sen­ate com­mit­tees, at least for now, ap­pear dead, ac­cord­ing to the text of a short-term gov­ern­ment spend­ing bill un­veiled late last night to keep fed­er­al agen­cies open un­til Dec. 16.

But the ab­sence of rid­ers (both sides pre­vi­ous­ly an­nounced a “prac­ti­cal­ly clean” deal last week) doesn’t mean De­moc­rats are done fight­ing to add these ac­cel­er­at­ed ap­provals and oth­er reg­u­la­to­ry re­forms for cos­met­ics, nu­tri­tion­al prod­ucts and di­ag­nos­tic tests.

As part of the agree­ment for a clean CR and user fee deal, De­moc­rats are look­ing to on­ly au­tho­rize cer­tain mea­sures that are tan­gen­tial to the ac­tu­al in­dus­try-FDA agree­ments un­til Dec. 16, which in­cludes all of Ti­tle V in the bill text.

Those par­tial reau­tho­riza­tions set up a like­ly bat­tle in mid-De­cem­ber over pro­grams like the Best Phar­ma­ceu­ti­cals for Chil­dren Pro­gram, which al­lows the NIH to fund stud­ies of off-patent drugs in chil­dren, the or­phan drug grants that de­fray the cost of de­vel­op­ing rare dis­ease drugs, and cer­tain re­port­ing re­quire­ments on pend­ing gener­ic drug ap­pli­ca­tions.

“All four cor­ners [ma­jor­i­ty and mi­nor­i­ty lead­ers in House and Sen­ate] com­mit­ted to re­turn­ing to the ne­go­ti­at­ing ta­ble ahead of the De­cem­ber gov­ern­ment fund­ing dead­line to re­vis­it these key pri­or­i­ties,” House En­er­gy & Com­merce com­mit­tee chair Frank Pal­lone (D-NJ) said in a state­ment last night. “I’m go­ing to con­tin­ue push­ing to ad­vance as much of the House-passed leg­is­la­tion as pos­si­ble.”

But out­side of these de­layed items (and it’s still un­clear who’s op­posed to reau­tho­riz­ing some or all of these mea­sures), De­moc­rats en­tire­ly caved to their Re­pub­li­can peers af­ter much dis­cus­sion and vot­ing on sev­er­al dif­fer­ent re­forms, some of which the FDA even seemed al­most ready to en­dorse. The shift came in late Ju­ly, af­ter Sen. Richard Burr, re­tir­ing mi­nor­i­ty leader on the Sen­ate HELP com­mit­tee, took a stand on a com­plete­ly clean user fee bill.

A clo­ture vote in the Sen­ate, which is like­ly the first step in get­ting the con­tin­u­ing res­o­lu­tion to Pres­i­dent Biden’s desk, is ex­pect­ed this evening. It’s still un­clear which Re­pub­li­cans will join sides with De­moc­rats and pass the spend­ing bill, which needs 60 votes to pass, al­though in­sid­ers don’t ex­pect a gov­ern­ment shut­down ahead of the midterm elec­tions.

Burr and Sen­ate HELP com­mit­tee chair Pat­ty Mur­ray (D-WA) said in a state­ment on the deal that

there is more work ahead this Con­gress to de­liv­er the kinds of re­forms fam­i­lies need to see from FDA, from in­dus­try, and from our men­tal health and pan­dem­ic pre­pared­ness ef­forts. As part of our agree­ment, we and our House coun­ter­parts are com­mit­ted to con­tin­u­ing that work, and in­clud­ing strong, bi­par­ti­san leg­is­la­tion in a ro­bust end of year pack­age.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.