President Biden delivers his State of the Union address on March 1, 2021 (Al Drago, Pool via AP Images)

Biden con­tin­ues his pledge for Medicare drug price ne­go­ti­a­tions in State of the Union speech

Pres­i­dent Joe Biden is not back­ing down on ad­vo­cat­ing for Medicare to ne­go­ti­ate drug prices. In his first State of the Union on Tues­day evening, which in ad­di­tion took Rus­sia to task over its in­va­sion of Ukraine, Biden re­vealed that cut­ting phar­ma­ceu­ti­cal prices is chief among the pri­or­i­ties of his do­mes­tic agen­da.

Biden and con­gres­sion­al De­moc­rats craft­ed wide-rang­ing drug pric­ing pro­vi­sions, in­clud­ing al­low­ing Medicare to ne­go­ti­ate for the first time, in the Build Back Bet­ter Act. But that bill and its parts now ap­pear dead, large­ly thanks to Sen. Joe Manchin (D-WV), who balked at some of the non-drug-re­lat­ed pro­vi­sions.

Still, Biden came out swing­ing for drug price ne­go­ti­a­tions Tues­day evening in the Capi­tol, pledg­ing his sup­port for cap­ping the cost of in­sulin for those with in­sur­ance at $35 a month as part of a last-ditch ef­fort to get some­thing passed, adding, “Drug com­pa­nies will still do very well. And while we’re at it let Medicare ne­go­ti­ate low­er prices for pre­scrip­tion drugs, like the VA al­ready does.”

Sev­enth grad­er Joshua Davis of Mid­loth­i­an, VA, and his moth­er sat in First La­dy Jill Biden’s box for the speech, and Biden, who was pre­vi­ous­ly in­tro­duced by Joshua at a re­cent in­sulin-re­lat­ed event, ex­plained his sto­ry.

“He and his Dad both have type 1 di­a­betes, which means they need in­sulin every day. In­sulin costs about $10 a vial to make. But drug com­pa­nies charge fam­i­lies like Joshua and his dad up to 30 times more. I spoke with Joshua’s mom. Imag­ine what it’s like to look at your child who needs in­sulin and have no idea how you’re go­ing to pay for it,” Biden said.

In­sulin prices have been in the crosshairs of Con­gress for years now, with House E&C com­mit­tee chair Frank Pal­lone (D-NJ) and sub­com­mit­tee chair Di­ana DeGette (D-CO) most re­cent­ly ex­plain­ing in let­ters to the largest three in­sulin man­u­fac­tur­ers that the price in the US is more than 10 times that of 33 oth­er coun­tries.

Sanofi’s own pric­ing re­port this year, re­leased Wednes­day, ex­plains how even pa­tients’ out-of-pock­et spend­ing on its in­sulin Lan­tus rose 82% be­tween 2012 and 2020.

But Sanofi and the oth­er in­sulin man­u­fac­tur­ers of­ten point to the fact that the rise in in­sulin prices and out-of-pock­et costs is due to the phar­ma mid­dle­men, the PBMs, which cre­ate this ever-widen­ing gap be­tween the list and net prices.

PhRMA CEO Stephen Ubl re­leased a rare state­ment fol­low­ing the SO­TU last night, con­tin­u­ing the in­dus­try group’s ar­gu­ment against al­low­ing Medicare to ne­go­ti­ate on drug prices, say­ing:

We urge Pres­i­dent Biden and Con­gress to work on a holis­tic so­lu­tion that fix­es what’s bro­ken in our health care sys­tem. Al­low­ing the gov­ern­ment to set the price of med­i­cines isn’t the an­swer. We know that sto­ry will end with less ac­cess to med­i­cines and less fu­ture in­no­va­tion, and we know there’s a bet­ter way. Let’s work to­geth­er on so­lu­tions that low­er costs for pa­tients, ad­dress abu­sive prac­tices with­in the in­sur­ance sys­tem and pro­tect the de­vel­op­ment of new cures and treat­ments.

In ad­di­tion to the drug pric­ing pro­vi­sions, Biden al­so an­nounced a new ini­tia­tive around Covid-19 ther­a­peu­tics.

Known as the “Test to Treat” ini­tia­tive, Biden said it will help peo­ple “get test­ed at a phar­ma­cy, and if they’re pos­i­tive, re­ceive an­tivi­ral pills on the spot at no cost.”

In clar­i­fy­ing com­ments, the White House said the ini­tia­tive is meant to “min­i­mize the time be­tween a pos­i­tive test re­sult and re­ceiv­ing an ef­fec­tive Covid-19 treat­ment, in­clud­ing an­tivi­ral pills and mon­o­clon­al an­ti­bod­ies … The Ad­min­is­tra­tion will be launch­ing these one-stop shops this month, with hun­dreds of sites open­ing na­tion­wide in­clud­ing at phar­ma­cy clin­ics at places like CVS, Wal­greens, and Kroger. The Ad­min­is­tra­tion will con­tin­ue to grow the pro­gram over time.”

Biden al­so dis­cussed get­ting clos­er to re­turn­ing to “nor­mal” af­ter Covid, and said that start­ing next week, Amer­i­cans can or­der an­oth­er round of Covid self-tests, even if they’ve al­ready or­dered some.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.

Eu­ro­pean Com­mis­sion lays ground­work to un­wind Il­lu­mi­na's $7B+ Grail merg­er

The European Commission has recommended steps that — though not yet final — would require Illumina to “swiftly” unwind its controversial $7.1 billion Grail buyout.

The Commission delivered a “statement of objections” on Monday, detailing the process Illumina would need to take in divesting Grail, its blood testing spinout launched in 2016. Illumina re-acquired Grail back in August, despite criticism from both the FTC and EU.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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