We don’t know when (ex­act­ly) Lil­ly will an­nounce the FDA’s baric­i­tinib de­ci­sion, but watch out for the loom­ing pric­ing squab­ble

Some­time in the next few days, the FDA will be right on the PDU­FA de­ci­sion dead­line for baric­i­tinib. We just don’t know which day.

For some rea­son, Eli Lil­ly $LLY has de­cid­ed to keep the dead­line un­der wraps, as con­firmed yes­ter­day by a spokesper­son for the com­pa­ny. It could be tonight, ahead of a long hol­i­day week­end in the US. It could be to­mor­row. They could even wait un­til Mon­day, af­ter the de­ci­sion is for­mal, to roll out their an­nounce­ment.

While de­layed from three months ago to some time in mid-April, just about every an­a­lyst be­lieves that — bar­ring some sort of man­u­fac­tur­ing is­sue or some oth­er un­ex­pect­ed sna­fu — Lil­ly and its biotech part­ner In­cyte $IN­CY have this one in the bag. And it’s an­oth­er whop­per.

Af­ter be­ing treat­ed to a string of block­buster OKs for Ocre­vus and Dupix­ent, baric­i­tinib — which will be mar­ket­ed as Olu­mi­ant — is look­ing to dis­rupt the rheuma­toid arthri­tis mar­ket. To do that, Lil­ly has care­ful­ly man­aged a drug that an­a­lysts be­lieve could earn up to about $2 bil­lion in peak sales.

Lil­ly is well known in the in­dus­try for its ap­petite for huge stud­ies and pricey com­par­isons with the com­pe­ti­tion. In this case, it paid off with new da­ta that demon­strat­ed su­pe­ri­or­i­ty over Hu­mi­ra in treat­ing rheuma­toid arthri­tis. Hu­mi­ra is still un­der patent pro­tec­tion, and will re­main so for as long as Ab­b­Vie can fight off gener­ic com­pe­ti­tion to the biggest rev­enue pro­duc­er in the com­pa­ny and one of the biggest drugs on the plan­et.

So the next big thing, if in­deed the FDA has giv­en baric­i­tinib the green light, will be the price.

A new re­port from ICER took is­sue with the price for Hu­mi­ra, which it post­ed as a net of $40,415 a year. And ICER pro­vid­ed a thumbs up for baric­i­tinib and sar­ilum­ab, an­oth­er drug from Re­gen­eron and Sanofi that got held up by one of those man­u­fac­tur­ing sna­fus. ICER clear­ly prefers sar­ilum­ab on ef­fi­ca­cy, though we don’t know the price, giv­ing its mar­gin­al stamp of ap­proval to baric­i­tinib.

Not sur­pris­ing­ly, Ab­b­Vie took ex­cep­tion to the re­port, and Lil­ly may well end up do­ing the same. In this brave new world, an FDA ap­proval is a pre­lude to the price de­bate. And this one should be a doozie.

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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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.

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.

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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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.

Bio­phar­ma ramps up lob­by­ing spend as drug pric­ing leg­is­la­tion nears

The top biopharma companies in the world collectively spent more than $40 million in just the first quarter of 2021 on lobbying Congress as part of preparations to stave off major drug pricing legislation that’s expected later this year.

Although the numbers are not dramatically higher than what the companies collectively spent in the first quarter of 2020, some like GlaxoSmithKline, Teva, Merck and Johnson & Johnson have already increased their quarterly lobbying spend in 2021 by about $1 million more each when compared to recent quarters in 2020.

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.

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.”