House Dems call on the FTC to in­ves­ti­gate po­ten­tial col­lu­sion among top three in­sulin man­u­fac­tur­ers

Strik­ing while the iron is hot, six House De­moc­rats sent a let­ter Thurs­day to the act­ing chair­woman of the FTC (10 days af­ter the FTC said it would crack down on phar­ma merg­ers), call­ing for an in­ves­ti­ga­tion in­to the po­ten­tial col­lu­sion of in­sulin mar­ket lead­ers Eli Lil­ly, Sanofi and No­vo Nordisk.

Katie Porter

Led by Rep. Katie Porter of Cal­i­for­nia, the let­ter notes that the three com­pa­nies raised the prices of their in­sulins in lock­step, and be­tween 2012 and 2016, the price of in­sulin al­most dou­bled. Sen. Bernie Sanders (I-VT) and the late Rep. Eli­jah Cum­mings of Mary­land sent a let­ter to the FTC rais­ing sim­i­lar charges of col­lu­sion among the same three com­pa­nies in 2016.

“It is a unique­ly Amer­i­can phe­nom­e­non that pa­tients with di­a­betes are reg­u­lar­ly forced to ra­tion in­sulin and risk death,” wrote Porter, along with De­mo­c­ra­t­ic Reps. Lloyd Doggett (TX), Cori Bush (MO), Prami­la Jaya­pal (WA), Pe­ter Welch (VT), and Ro Khan­na (CA).

Last March, the FDA of­fi­cial­ly tran­si­tioned in­sulin prod­ucts from all three com­pa­nies from drugs to bi­o­log­ics, mean­ing com­pe­ti­tion would have to come in the form of biosim­i­lars, or even in­ter­change­able biosim­i­lars, rather than gener­ics.

Scott Got­tlieb

“The tran­si­tion of in­sulin from the drug to the bi­o­log­ics path­way will open up these prod­ucts to biosim­i­lar com­pe­ti­tion,” for­mer FDA com­mis­sion­er Scott Got­tlieb said in April 2019. “We’re al­ready see­ing ro­bust ac­tiv­i­ty among spon­sors seek­ing to bring for­ward biosim­i­lar copies of in­sulin.”

But one year since that tran­si­tion oc­curred, and the fruits of that ac­tiv­i­ty have not trans­lat­ed in­to new in­sulin biosim­i­lars yet.

For now, the House De­moc­rats are call­ing on the Biden ad­min­is­tra­tion to do some­thing, say­ing any ac­tion would align with its “com­mit­ment to equal­i­ty” as Black Amer­i­cans are fac­ing an epi­dem­ic of am­pu­ta­tions “large­ly caused by ex­or­bi­tant in­sulin prices,” the De­moc­rats wrote.

“It is clear that the in­sulin mar­ket is bro­ken, and we be­lieve that an FTC in­ves­ti­ga­tion and in­ter­ven­tion is long over­due,” they added.

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 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.

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.

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.

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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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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