Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden ad­min­is­tra­tion tries to wran­gle the de­tails of its in­fra­struc­ture bill, Sen­ate Fi­nance Com­mit­tee Chair Ron Wyden (D-OR) took a con­crete step for­ward on drug pric­ing re­forms on Tues­day and un­veiled five prin­ci­ples for such re­forms, in­clud­ing pro­vid­ing Medicare with the abil­i­ty to ne­go­ti­ate prices.

“Al­low­ing the Sec­re­tary of HHS to ne­go­ti­ate the price Medicare will pay cre­ates a much need­ed mech­a­nism to achieve fair­er prices when the mar­ket has failed to do so,” Wyden wrote.

The call for such ne­go­ti­a­tions rep­re­sents a shift for Wyden, as he pre­vi­ous­ly au­thored a drug pric­ing re­form bill with Sen. Chuck Grass­ley (R-IA) that did not in­clude such ne­go­ti­a­tions.

So why the shift? Wyden said that many old­er drugs com­mand high prices be­cause they face no com­pe­ti­tion from gener­ics and oth­er new drugs launch at steep prices with lit­tle jus­ti­fi­ca­tion. As an ex­am­ple of an un­fair launch price, he point­ed to Bio­gen’s new Alzheimer’s drug Aduhelm, which launched at a price that’s “far be­yond any rea­son­able jus­ti­fi­ca­tion of the clin­i­cal val­ue to pa­tients, care­givers, or so­ci­ety.”

The new plan comes as a coali­tion of em­ploy­ers and health care pur­chasers are call­ing on the top House and Sen­ate lead­ers to take a hard look at the “as­tro­nom­i­cal price” of Aduhelm and “move bold­ly” to en­act pre­scrip­tion drug pric­ing re­form.

But Wyden sounds more keen on a tar­get­ed, rather than a one-size-fits-all ap­proach.

In craft­ing a price ne­go­ti­a­tion pol­i­cy, Con­gress must tack­le four is­sues, ac­cord­ing to Wyden: “a. Es­tab­lish clear cri­te­ria for mar­ket fail­ure and for which drugs to ne­go­ti­ate the price; b. De­fine what con­sti­tutes a fair price in these cir­cum­stances; c. Give the Sec­re­tary both tools and guide­lines to ne­go­ti­ate a fair price; and d. Cre­ate the right in­cen­tives to en­sure that phar­ma­ceu­ti­cal com­pa­nies par­tic­i­pate in the ne­go­ti­a­tion process.”

While the time­line on when a bill may be draft­ed is un­known at this point, price re­form ad­vo­cates have been push­ing for some­thing this sum­mer, while in­dus­try ad­vo­cates are look­ing to do what they can to stop price con­trols.

An­oth­er top pri­or­i­ty for Wyden in ad­dress­ing drug pric­ing is en­sur­ing that pa­tients see sav­ings at the phar­ma­cy counter, es­pe­cial­ly for spe­cif­ic types of crit­i­cal drugs, such as in­sulin, for which “the re­bate dy­nam­ics are ex­treme and in­hibit­ing ac­cess.”

Wyden al­so said he wants to re­quire re­bates on drug price hikes above in­fla­tion to rein in com­pa­nies that gouge the mil­lions who take old­er drugs, and he wants to ex­tend these pric­ing re­forms be­yond Medicare and Med­ic­aid.

“Poli­cies that tar­get both ex­or­bi­tant prices of drugs and re­duce out-of-pock­et spend­ing for pa­tients must ex­tend be­yond Medicare,” he wrote.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Pascal Soriot, AstraZeneca CEO (via Getty images)

As­traZeneca's MCL-1 can­cer drug put on hold af­ter flag­ging a safe­ty is­sue — 2 years af­ter Am­gen axed ri­val drug

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca is now flagging safety issues for a rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.” There was no further explanation and a spokesperson for AstraZeneca hadn’t followed up with us ahead of our publishing deadline.

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FDA shoots down a biotech’s last-stand pa­tient pitch af­ter fault­ing da­ta

Stealth BioTherapeutics appeared unsure its pitch for an ultra-rare disease would be accepted when submitting an NDA in August, and on Wednesday its fears came to pass.

The FDA issued Stealth a refusal to file letter for a candidate looking to treat Barth syndrome, the biotech announced Wednesday morning. It’s a move not entirely unexpected, given Stealth’s own admission earlier this year that the agency didn’t find existing data to support NDA review.

Kelly Martin, Radius Health CEO

Ra­dius rock­ets high­er as Kel­ly Mar­tin boasts of a big PhI­II suc­cess — but the spoils be­long to Menar­i­ni

Radius Health stuck with some fuzzy top-line Phase III results for its oral SERD therapy elacestrant, but investors saw enough to push a rally that sparked a big surge in its share price.

According to researchers, the drug hit both primary endpoints among ER+/HER2- breast cancer patients: beating standard of care on progression-free survival in the overall population and PFS with tumors harboring estrogen receptor 1 mutations — a key factor in developing resistance. And while some analysts were left wondering about specific data, most of the crowd seemed happy to hear that the drug is now being steered to the FDA.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.