An in­tel­lec­tu­al prop­er­ty law firm says that re­cent guid­ance from the UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency hints at the pos­si­bil­i­ty of the agency al­low­ing ap­provals from oth­er reg­u­la­tors, in­clud­ing pos­si­bly the US FDA, to play a role in UK reg­u­la­to­ry process­es.

Marks & Clerk, based out of Lon­don, wrote in a blog post that guid­ance from the UK’s reg­u­la­to­ry agency from late Jan­u­ary is pro­vid­ing more con­text in­to po­ten­tial in­ter­na­tion­al col­lab­o­ra­tion with oth­er reg­u­la­tors. How that would come about is af­ter the UK’s “Re­liance Pro­ce­dure” — a way to en­sure pa­tients in Great Britain post-Brex­it could still ac­cess new med­i­cines — ex­pires.

The pro­ce­dure, in short, al­lows MHRA to uti­lize pos­i­tive EC de­ci­sions to fast-track the ap­proval process for mar­ket­ing au­tho­riza­tions in Great Britain. Back in Sep­tem­ber, the agency an­nounced that the pro­ce­dure would be ex­tend­ed through the end of 2023.

As for what would be next, the MHRA put out word on Jan. 24:

From 1 Jan­u­ary 2024 you can ap­ply to MHRA through our new in­ter­na­tion­al recog­ni­tion frame­work, which will have re­gard to de­ci­sions al­ready made by the Eu­ro­pean Med­i­cines Agency and cer­tain oth­er reg­u­la­tors.

The law firm added at the time that it re­mains to be seen which reg­u­la­tors would be in­clud­ed in the new sys­tem, but it ref­er­enced the sim­i­lar­i­ty of in­ter­na­tion­al col­lab­o­ra­tion akin to Pro­ject Or­bis — a pro­gram set up by the FDA in 2019 to col­lab­o­rate with dif­fer­ent in­ter­na­tion­al agen­cies on sub­mis­sion and re­view of can­cer treat­ments. The project now in­cludes reg­u­la­tors from the US, UK, Aus­tralia and five oth­er au­thor­i­ties.

The firm added that the an­nounce­ment would “no doubt be wel­come news to com­pa­nies who see Great Britain as a key part of a mul­ti-ju­ris­dic­tion­al launch strat­e­gy.” The firm ad­di­tion­al­ly not­ed that al­low­ing the MHRA to es­sen­tial­ly “pig­gy-back” on au­tho­riza­tions from oth­er reg­u­la­tors could have ad­van­tages.

While FDA did not com­ment to End­points News be­fore dead­line, the MHRA on­ly re­it­er­at­ed what it had said be­fore: “We will com­mu­ni­cate who these ad­di­tion­al reg­u­la­tors are and pub­lish de­tailed guid­ance about this new frame­work in due course, in­clud­ing any tran­si­tion arrange­ments for ap­pli­ca­tions re­ceived un­der ex­ist­ing frame­works.”

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.”

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.