With the pub­lic health emer­gency and the na­tion­al emer­gency de­c­la­ra­tion ex­pect­ed to ex­pire on May 11, the FDA will be let­ting some guid­ance doc­u­ments ex­pire along with it.

In a doc­u­ment pub­lished Fri­day in the Fed­er­al Reg­is­ter, the FDA said that of the 72 Covid-19 guid­ances that are still ac­tive, 22 will no longer be in ef­fect when the de­c­la­ra­tions ex­pire.

Those guid­ance docs that are be­ing cut, and which typ­i­cal­ly of­fered some le­nien­cy from the FDA due to the con­straints of the pan­dem­ic, in­clude ones re­lat­ed to man­u­fac­tur­ing con­sid­er­a­tions for cell and gene ther­a­pies, non­hu­man pri­mate sup­ply con­straints, sta­tis­ti­cal con­sid­er­a­tions for clin­i­cal tri­als and more.

“Be­cause these COVID-19 guid­ances will not be need­ed when the PHE de­c­la­ra­tion ex­pires, FDA is not ex­tend­ing them. In oth­er in­stances, the sci­ence be­hind cer­tain rec­om­men­da­tions has ad­vanced, and FDA may want to up­date cer­tain guid­ances to re­flect new da­ta,” the FDA said.

How­ev­er, some guid­ance doc­u­ments will not be go­ing away im­me­di­ate­ly — 22 oth­ers can be dis­con­tin­ued, but with a “wind-down” pe­ri­od. Those guid­ances will re­main in ef­fect for an ex­tra 180 days af­ter the ex­pi­ra­tion, last­ing un­til Nov. 7.  These in­clude a guid­ance about con­va­les­cent plas­ma, vac­cine de­vel­op­ment, man­u­fac­tur­ing in­spec­tions, and cer­tain REMS re­quire­ments.

A to­tal of 24 re­lat­ed guid­ances will still be re­tained but will have some changes made af­ter the ex­pi­ra­tion of the de­c­la­ra­tion, which in­cludes ones re­lat­ed to EUAs for vac­cines to pre­vent Covid-19, the de­vel­op­ment and li­cen­sure of Covid-19 vac­cines, and par­tic­u­lars around de­vel­op­ing med­i­cines to treat the virus.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”