End­points News as­sess­es the big bio­phar­ma R&D sto­ry this week in a spe­cial year-end send­off. Chances are, this is al­so what we’ll be talk­ing about in 2017. And it will cer­tain­ly be front and cen­ter at the up­com­ing J.P. Mor­gan Health­care Con­fer­ence.

The Sen­ate of­fers a weak re­sponse to price goug­ing

The Sen­ate this week high­light­ed just how lit­tle the bio­phar­ma in­dus­try needs to fear from law­mak­ers when it comes to con­trol­ling drug prices right now. In­ves­ti­gat­ing four clear cas­es of price goug­ing on old prod­ucts, two or­ches­trat­ed by Mar­tin Shkre­li, the Sen­ate pol­ished off a mix of dusty reg­u­la­to­ry in­cen­tives as their sug­ges­tion for rein­ing in prof­i­teer­ing: “spe­cial” pri­or­i­ty re­views when need­ed, vouch­ers to help re­ward a fast re­sponse, maybe a spe­cial reim­por­ta­tion pass to pro­vide cheap com­pe­ti­tion, a man­date to move gener­ics through the FDA faster. None of it would ac­tu­al­ly nip the whole thing in the bud. “It is pos­si­ble that the busi­ness mod­el pur­sued by the Valeants and Tur­ings of the world was at­trac­tive in part be­cause it was le­gal,” the re­port states, in a mas­sive un­der­state­ment. (Ya think?) Noth­ing the sen­a­tors sug­gest­ed would ac­tu­al­ly pre­vent the next Shkre­li from do­ing ex­act­ly the same thing. If law­mak­ers are un­will­ing to tack­le ob­vi­ous price goug­ing, then what are the chances they can ever come to grips with the much big­ger is­sue of sys­temic rip-offs, the an­nu­al price spikes that have kept Big Phar­ma look­ing healthy as their R&D ef­forts con­tin­ue to un­der­per­form?

It’s time to get re­al

Drug pric­ing as a po­tent po­lit­i­cal is­sue, though, isn’t go­ing any­where. As Shkre­li told mein a Twit­ter ex­change on Thurs­day, the two deals he en­gi­neered for Tur­ing and Retrophin are still mak­ing plen­ty of “guap” as law­mak­ers fud­dle about. Don­ald Trump has made his own broad, un­de­fined pledge to con­trol pric­ing. And elect­ed of­fi­cials have to be acute­ly aware that the pub­lic’s anger will on­ly grow. One of the most com­pelling in­dus­try re­spons­es has been Al­ler­gan CEO Brent Saun­ders’ pledge to hold an­nu­al price in­creas­es to sin­gle dig­its.

Fair pric­ing prac­tices on old­er drugs will be es­sen­tial to main­tain­ing greater con­trol over the price of new drugs. It’s im­por­tant to re­mem­ber that pub­lic anger is not fixed on the price of im­por­tant new drugs that make a dif­fer­ence in peo­ple’s lives. It’s the old­er drugs, where the price goes up when the fran­chise should be fad­ing in val­ue, that rile the peo­ple and of­fend their sense of fair­ness. No one likes be­ing ripped off. And with­out ag­gres­sive pric­ing on many, though not nec­es­sar­i­ly all, new drugs, R&D will be­come un­sus­tain­able.

If this is­sue has your at­ten­tion, I’d en­cour­age you to come to End­points News’ first live event dur­ing the J.P. Mor­gan Health­care Con­fer­ence in San Fran­cis­co, where we’ll be joined by Saun­ders and a great pan­el dis­cussing the sin­gle most press­ing is­sue of the year.

Your tick­et rev­enue will be used to help grow the pub­li­ca­tion in 2017. So you can view this as a way to par­tic­i­pate in a great dis­cus­sion, a net­work­ing event you won’t want to miss, and a sign of your sup­port for what we’re do­ing here.

John Car­roll, Ed­i­tor

Hap­py hol­i­days, and I hope to see you in San Fran­cis­co Jan­u­ary 10.— John Car­roll

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.

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.