CBO warns of al­most 60 few­er new drugs over three decades with Medicare drug ne­go­ti­a­tions bill

As drug pric­ing leg­is­la­tion be­gins to gain steam on Capi­tol Hill mov­ing in­to the fall, the Con­gres­sion­al Bud­get Of­fice is of­fer­ing an up­dat­ed look at the ef­fects that House Speak­er Nan­cy Pelosi’s drug pric­ing bill, known as HR 3, would have in chill­ing bio­phar­ma R&D over 30 years.

Nan­cy Pelosi

CBO said in a new re­port Thurs­day that its up­dat­ed mod­el used to es­ti­mate the ef­fects of HR 3 would, in part, al­low for wide­spread Medicare ne­go­ti­a­tions on drug prices, lead­ing to a 15% to 25% re­duc­tion in ex­pect­ed re­turns for drugs in the top quin­tile of ex­pect­ed re­turns.

Last Feb­ru­ary, the CBO es­ti­mat­ed that Medicare ne­go­ti­a­tions un­der the same bill would re­duce prices by be­tween 57% and 75%, rel­a­tive to cur­rent prices.

The lat­est es­ti­mates could lead to 2 few­er drugs in the first decade, 23 few­er in the sec­ond decade, and 34 few­er in the third decade, CBO said. While that to­tal of 59 few­er new drugs over three decades would like­ly re­sult in the loss of mean­ing­ful new drugs, the to­tal doesn’t align with in­dus­try lob­by­ing group PhRMA’s es­ti­mate in May that HR 3 could re­duce by 90%+ the num­ber of med­i­cines de­vel­oped by small and emerg­ing biotechs, or 61 few­er drugs over 10 years.

But where­as PhRMA says such a change could threat­en ac­cess to med­i­cines, the CBO stopped short of try­ing to tease out ex­act­ly what the loss of those drugs might mean, par­tic­u­lar­ly as the FDA ap­proves plen­ty of me-too or slight­ly im­proved ver­sions of cur­rent­ly mar­ket­ed drugs each year.

“The il­lus­tra­tive pol­i­cy’s ex­act im­pli­ca­tions for the health of fam­i­lies in the Unit­ed States are un­clear. CBO has es­ti­mat­ed nei­ther which types of drugs may be af­fect­ed nor how the re­duc­tion in the num­ber of new drugs will af­fect health out­comes. In ad­di­tion, the pol­i­cy may lead to low­er prices and in­creased us­age for drugs al­ready on the mar­ket. CBO has not de­ter­mined the over­all ef­fect of the pol­i­cy on health out­comes,” the re­port says.

The re­lease of the re­port al­so comes as it seems un­like­ly that the Sen­ate will take up HR 3 in its en­tire­ty, which passed the House in 2019.

Ron Wyden

Sen­ate fi­nance com­mit­tee chair Ron Wyden (D-OR), who’s craft­ing his own leg­is­la­tion, ear­li­er this sum­mer vowed to in­clude some form of Medicare ne­go­ti­a­tions in the Sen­ate’s pack­age, which like­ly won’t need Re­pub­li­can votes to make it in­to law.

And while the CBO lays out its ex­pect­ed new drug loss­es over three decades, the gov­ern­ment agency al­so made clear how dif­fi­cult it can be to pre­dict what drugs will prove pos­i­tive in mul­ti­ple stages of clin­i­cal tri­als and win ap­proval.

“The ef­fects could be small­er if ex­pen­di­tures in late-phase hu­man tri­als are larg­er, for ex­am­ple. Al­ter­na­tive­ly, the ef­fects could be larg­er if the cost of cap­i­tal is larg­er,” the CBO said.

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.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

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.

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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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.