The Sen­ate fum­bles its first stab at phar­ma prof­i­teer­ing, keep­ing the is­sue front and cen­ter in 2017

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

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.