Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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President Biden at last year's State of the Union address, March 1, 2022 (Al Drago/Pool via AP Images)

Biden to tout phar­ma's de­feat in State of the Union, call for $35 in­sulin for all

President Joe Biden will take to his second State of the Union this evening with plans for optimism, and a call for universal, $35 per month insulin, along with highlights of one of his biggest self-described successes so far — the defeat of pharma companies with the institution of Medicare negotiations for drug prices.

“President Biden took on Big Pharma — and won,” a White House fact sheet said ahead of the speech this evening.

Levi Garraway, Roche CMO and EVP of global product development (Genentech)

Roche says its C5 in­hibitor aced PhI­II head-to-head tri­als with As­traZeneca’s Soliris

One of the new drugs Roche is banking on for a 2023 launch has cleared two Phase III trials, the company reported.

Roche’s Genentech tested crovalimab, a C5 inhibitor, in two different groups of patients with the rare blood disorder paroxysmal nocturnal hemoglobinuria and reached two conclusions: Firstly, its drug works just as well as AstraZeneca’s blockbuster Soliris, a current standard of care, among patients who have not been treated with complement inhibitors; and secondly, it’s safe for patients to switch from currently approved C5 inhibitors to crovalimab.

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FDA as­sem­bles ad­comm to re­view GSK's Jem­per­li tri­al plans in rec­tal can­cer

The FDA’s Oncologic Drugs Advisory Committee will meet this Thursday to discuss whether proposed studies would support an accelerated approval for GSK’s Jemperli in rectal cancer — despite initial concerns about the trial plans.

GSK’s PD-1 blocker Jemperli, also known as dostarlimab, was first approved back in 2021 for a specific subset of recurrent or advanced endometrial cancer patients who have genetic feature called dMMR, or deficient mismatch repair. The label was expanded months later to include all adults with dMMR recurrent or advanced solid tumors who have progressed or stagnated on earlier therapy.

#JPM23: This is how we cure can­cer

Curing cancer, or finding new ways to achieve curative progress, extending lives, has become a hotbed of activity in biopharma. Endpoints Editor-in-Chief John Carroll sat down at JP Morgan with a group of industry experts working on that. This transcript has been edited for brevity and clarity.

John Carroll:

This is a subject that I’ve been covering forever, and I seem to understand less and less what’s going on as I go deeper and deeper into what’s happening. So I’ve brought together five great experts in the field to talk about one of the most important trends in research and development today, which is where are we going to find the very big transformational therapies in the near term that are going to make some significant differences to patients.

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Pfiz­er or­dered to dis­close FBI com­mu­ni­ca­tions in trade se­crets case

A federal judge has ordered Pfizer to hand over its communications with the FBI in a trade secrets case it brought against the founders of Regor Therapeutics last year.

Pfizer filed suit last February against two former employees, Xiayang Qiu and Min Zhong, who quit their Big Pharma jobs in 2018 to launch the Eli Lilly-partnered startup Regor. About five months after leaving Pfizer, Qiu and Zhong applied for patents on a set of compounds that plaintiffs allege “appear strikingly similar to . . . compounds that Pfizer had developed,” according to court documents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Chat­G­PT and gen­er­a­tive AI land in phar­ma mar­ket­ing with sense of awe — and plen­ty of cau­tion

A professionally dressed woman stands in front of an office background and introduces herself to talk about the use of artificial intelligence in pharma marketing.

Except she’s not a real person. “She” is an AI-generated avatar in a video created in less than a minute using the generative AI application Synthesia along with a typed script from a real person — in this case, a healthcare agency executive showing an example of how a generative AI avatar can work.

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Mar­ket­ingRx roundup: Pfiz­er plans mar­ket­ing spend bump for 2023; Am­gen, Mer­ck join ‘Pro­ject Black’ eq­ui­ty fund­ing

Pfizer debuted its first brand campaign for its Covid-19 treatment Paxlovid and mentioned in an Endpoints News Grammy Awards story yesterday, but it’s worth noting again. Until now, Pfizer has been encouraging people to go to a healthcare provider quickly — to the tune of more than $108 million in NFL TV ad placements alone, according to real-time TV ad tracker iSpot.tv.

There’s also no reason to expect the advertising will stop. Not only are Paxlovid treatments underused, but also Pfizer has earmarked funds for spending. It reported last week that it plans to spend an extra $1.3 billion in 2023 “to support anticipated new launches, acquired assets and commercial launch of COVID-19 products” for a total expected selling, informational and administrative (SI&A) tab of $13.8 billion to $14.8 billion for 2023. The spending bump follows a 17% SI&A increase in the fourth quarter of 2022.

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