Pfiz­er and BioN­Tech are seek­ing full ap­proval for their Omi­cron-tar­get­ed bi­va­lent Covid shot, and they’re fol­low­ing an FDA ad­vi­so­ry com­mit­tee’s ad­vice on “har­mo­niz­ing” vac­cine com­po­si­tions.

The part­ners have filed a sup­ple­men­tal BLA for their Omi­cron BA.4/BA.5-adapt­ed bi­va­lent Covid-19 vac­cine as both a pri­ma­ry dose or a boost­er for pa­tients over the age of 12. That means un­vac­ci­nat­ed chil­dren and adults could skip the orig­i­nal pri­ma­ry se­ries and re­ceive a bi­va­lent shot first.

The move is in re­sponse to an FDA Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) vote last month, in­tend­ed to clear up con­fu­sion around vary­ing pri­ma­ry and boost­er dose for­mu­la­tions and uti­lize vac­cines that bet­ter tar­get cur­rent­ly cir­cu­lat­ing strains of Covid.

Pfiz­er/BioN­Tech’s bi­va­lent vac­cine is avail­able, but on­ly un­der an emer­gency use au­tho­riza­tion (EUA) as a sin­gle boost­er dose for ages 5 years and old­er and as the third dose in the three-dose pri­ma­ry se­ries for chil­dren 6 months old through 4 years old.

In the EU, the bi­va­lent vac­cine al­ready has full mar­ket­ing au­tho­riza­tion as a boost­er dose in pa­tients five years and old­er who have com­plet­ed a pri­ma­ry vac­ci­na­tion course against Covid-19.

The plan now for Pfiz­er/BioN­Tech is to sub­mit ap­pli­ca­tions to the Eu­ro­pean Med­i­cines Agency for the mar­ket­ing au­tho­riza­tion to al­so in­clude the bi­va­lent vac­cine as a pri­ma­ry vac­ci­na­tion in pa­tients 5 years and old­er.

Mod­er­na has its own Omi­cron-tar­get­ing vac­cine boost­ers, but it’s un­clear when the com­pa­ny plans on fil­ing its own sBLA.

No­vavax is al­so work­ing on an up­dat­ed vac­cine, ei­ther mono­va­lent or bi­va­lent, for the 2023-2024 vac­ci­na­tion sea­son, CMO Fil­ip Dubovsky said last month.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

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.

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.”