When in space, your in­ner ma­chin­ery can go awry — ask as­tro­naut Scott Kel­ly. The as­sault of pro­tract­ed ra­di­a­tion and mi­cro­grav­i­ty can cul­mi­nate in pro­gres­sive bone and mus­cle loss and vex the im­mune sys­tem. Pla­cen­ta-based stem cells may be the an­swer to lim­it­ing that dam­age, and Is­rael’s Pluris­tem is work­ing with NASA to de­vel­op such an an­ti­dote.

The com­pa­ny, which is al­so work­ing with the NIH and the US De­part­ment of De­fense, last year se­cured the FDA’s emer­gency use au­tho­riza­tion for its stem cell prod­uct for ra­di­a­tion poi­son­ing. It al­so has two late-stage pro­grams test­ing the po­ten­tial of its ex­per­i­men­tal stem cell ther­a­pies for use in crit­i­cal limb is­chemia and mus­cle in­jury fol­low­ing sur­gi­cal re­pair. The com­pa­ny’s off-the-shelf prod­uct is de­rived from pla­cen­ta fol­low­ing full term de­liv­ery, and the cells can be ad­min­is­tered to pa­tients with­out the need for tis­sue match­ing.

“Once the cells are in­ject­ed, they se­crete a va­ri­ety of pro­teins and cy­tokines that help the body re­gen­er­ate, em­pow­er­ing the body’s heal­ing abil­i­ty,” Pluris­tem’s co-chief Yaky Yanay told End­points News.

The NASA tie-up came about af­ter Ruth Globus, of NASA’s Ames Re­search Cen­ter in Sil­i­con Val­ley, was giv­en the 2019 NASA Ames Re­search In­no­va­tion Award on the ba­sis of her pro­posed col­lab­o­ra­tion with Pluris­tem.

“Un­less as­tro­nauts al­lo­cate about two hours of time for dai­ly ex­er­cise ses­sions…As­tro­nauts can ex­pe­ri­ence up to 20% mus­cle loss in mus­cle mass on space flights last­ing just five to eleven days and in longer mis­sions, they al­so lose bone den­si­ty at a rate of 1-2% per month which can lead to more frag­ile bones,” Globus said in a state­ment on Wednes­day.

Last week, it was re­port­ed that near­ly a year in space put as­tro­naut Scott Kel­ly’s im­mune sys­tem in hy­per­drive. Typ­i­cal­ly as­tro­nauts are in space about six months at a time, but Kel­ly set a US record af­ter spend­ing 340 days in the skies.

Through Pluris­tem’s work with the NIH and DoD, the com­pa­ny was in­tro­duced to NASA and showed the space agency its da­ta from its mus­cle re­gen­er­a­tion stud­ies. Now with the NASA part­ner­ship in place, the drug de­vel­op­er is gear­ing up for pre­clin­i­cal and in vit­ro stud­ies to test the po­ten­tial of its pla­cen­tal stem cells in pre­vent­ing and treat­ing med­ical con­di­tions caused dur­ing space mis­sions, in­clud­ing in­di­ca­tions re­lat­ing to blood, bone, mus­cle, brain and heart.

Da­ta are ex­pect­ed lat­er this year, and if pos­i­tive, Pluris­tem will work with the FDA to de­ter­mine how to con­duct in-hu­man stud­ies.

“If we are able to demon­strate it in space, which is an ac­cel­er­a­tor (of ag­ing), its some­thing we can use in earth as well, to sup­port well be­ing, ag­ing and qual­i­ty of life,” Yanay said. “Cell ther­a­py on one hand, and space mis­sion on the oth­er end — on­ly good things can come from that!”

Yaky Yanay. PLURIS­TEM via TWIT­TER

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.

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.