Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Sen­ate Fi­nance De­moc­rats took aim at Bio­gen’s pricey new Alzheimer’s drug on Thurs­day, but mem­bers on both sides of the aisle at a sep­a­rate ap­pro­pri­a­tions hear­ing didn’t ques­tion act­ing FDA com­mis­sion­er Janet Wood­cock on the ap­proval.

“I was ap­palled that Bio­gen priced their Alzheimer’s drug ap­proved by the FDA at $56,000 per year — I’m not go­ing to de­bate whether this is ef­fec­tive or not, but it’s dou­ble the house­hold me­di­an in­come for Michi­gan­ders over the age of 65,” Sen. Deb­bie Stabenow (D-MI) said at the fi­nance hear­ing.

Chair Ron Wyden (D-OR), while pledg­ing to re-open his drug pric­ing leg­is­la­tion from the last Con­gress that would al­low for CMS to ne­go­ti­ate drug prices, added, “If on­ly a frac­tion of peo­ple suf­fer­ing from Alzheimer’s were pre­scribed Aduhelm, Medicare Part B spend­ing would dou­ble overnight.”

He al­so not­ed the more than $11,000 in co-in­sur­ance each year for those on the new Alzheimer’s in­fu­sion, adding that “over­whelm­ing­ly, the Amer­i­can pub­lic sup­ports this idea” of fur­ther gov­ern­ment drug price ne­go­ti­a­tions. And he sig­naled that Pres­i­dent Biden’s pick for a new FDA com­mis­sion­er is on the way.

The sen­a­tor’s com­ments fol­low ques­tions from Wall Street an­a­lysts ear­li­er in the week on the steep price tag for ad­u­canum­ab.

Xavier Be­cer­ra

HHS Sec­re­tary Xavier Be­cer­ra of­fered lim­it­ed de­tail on his plan for drug price ne­go­ti­a­tions, but said he re­mained open to sit­ting down and com­ing up with a so­lu­tion.

“The phar­ma­ceu­ti­cal lob­by­ists are out there fear mon­ger­ing, and press­ing us to pass some wa­tered-down bill that fails to tack­le drug prices head on, how do you think Con­gress should re­spond?” Sen. Eliz­a­beth War­ren (D-MA) said, not­ing that it’s part of the pres­i­dent’s agen­da.

Be­cer­ra said he’ll leave it to Con­gress on what to craft, but said he thinks there should be a gen­er­a­tional change on how to do busi­ness when it comes to pre­scrip­tion med­ica­tion.

War­ren called for “all of the pri­or­i­ties,” in­clud­ing au­tho­riz­ing price ne­go­ti­a­tions “with re­al mus­cle,” ex­pand­ing Medicare ben­e­fits, and low­er­ing the Medicare el­i­gi­bil­i­ty age.

Oth­er De­moc­rats sound­ed split on what to do with drug prices.

Sen. Bob Menen­dez (D-NJ), whose dis­trict in­cludes some bio­phar­ma com­pa­nies and is a crit­i­cal vote for De­moc­rats with the 50-50 Sen­ate split, said he’s con­cerned that the gov­ern­ment con­sis­tent­ly takes rev­enue from the in­dus­try but that doesn’t low­er the costs of drugs for con­sumers.

“For me, the bot­tom line is show me how you’re go­ing to low­er the price for con­sumers on pre­scrip­tion drugs,” and in a way that doesn’t stop in­dus­try from pro­duc­ing more life-sav­ing vac­cines, Menen­dez said. Two oth­er Sen­ate De­moc­rats, Tom Carp­er (DE) and Cather­ine Cortez Mas­to (NV), who in­tro­duced price trans­paren­cy leg­is­la­tion last year, sig­naled ear­li­er that they might al­so not be ready for a big drug price ne­go­ti­a­tion bill.

Sen. Ben Cardin (D-MD) al­so raised ques­tions on how HHS is deal­ing with drug short­ages in light of the pan­dem­ic, es­pe­cial­ly when the prof­it mo­tive is non-ex­is­tent.

“We’re try­ing to boost the sup­ply,” Be­cer­ra said, in­clud­ing through the use of more do­mes­tic man­u­fac­tur­ing.

Wood­cock silent on ad­u­canum­ab

In an­oth­er hear­ing on Thurs­day be­fore a Sen­ate Ap­pro­pri­a­tions sub­com­mit­tee, act­ing FDA com­mis­sion­er Janet Wood­cock tes­ti­fied on the FDA’s 2022 bud­get plan but said noth­ing of Mon­day’s ap­proval of Bio­gen’s Aduhelm.

Pa­trizia Cavaz­zoni

None of the sen­a­tors ques­tioned Wood­cock on the ac­cel­er­at­ed ap­proval, and her name has re­mained large­ly out of the spot­light since the ap­proval de­ci­sion was an­nounced by the agency. FDA state­ments all came from CDER di­rec­tor Pa­trizia Cavaz­zoni and OND di­rec­tor Pe­ter Stein, in ad­di­tion to a let­ter from neu­ro­science head Bil­ly Dunn to the ad­vi­so­ry com­mit­tee that vot­ed against its ap­proval.

On­ly Sen. Jer­ry Moran (R-KS), a mem­ber of the Con­gres­sion­al Task Force on Alzheimer’s Dis­ease, men­tioned the ap­proval, and he praised Wood­cock on it.

Mean­while, three mem­bers of the ad­vi­so­ry com­mit­tee that re­viewed ad­u­canum­ab have now re­signed in protest over the ap­proval.

Both sides of the aisle al­so com­mend­ed the FDA for quick­ly of­fer­ing EUAs for the Covid-19 vac­cines from Pfiz­er, Mod­er­na and J&J and en­sur­ing they’re safe and ef­fec­tive.

Wood­cock’s tes­ti­mo­ny high­light­ed her agency’s bud­get plan, which seeks a net bud­get au­thor­i­ty in­crease of $322 mil­lion, the bulk of which would go for in­fra­struc­ture in­vest­ments, and an in­crease of $18.8 mil­lion to ORA’s base fund­ing to sup­port FDA’s in­spec­tions pro­gram.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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