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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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