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Good day, everybody. Damian right here with information of an averted activist problem, biotech on late-night TV, and the most recent deal in oncology’s hottest house.
BioMarin appeases an activist
Alexander Hardy, the brand new CEO of BioMarin Pharmaceutical, had an unenviable introduction to the job. Weeks earlier than his first day, Elliott Administration, a famed and formidable activist investor, disclosed a large stake in BioMarin, suggesting bother forward for a administration staff that had but to get began.
A month later, BioMarin appears to have sorted it out. The corporate mentioned yesterday it had signed an settlement with Elliott underneath which BioMarin will add three new board members, conduct a overview of company technique, and host an investor day subsequent yr. Elliott, in change, endorsed Hardy as “the fitting chief for this chapter of BioMarin’s worth creation story” and implicitly dominated out agitating for main managerial adjustments.
Elliott’s curiosity arrived at some extent of relative weak point for BioMarin. The corporate lately scaled again its gross sales projections to account for a sluggish launch of its gene remedy for hemophilia A. However not like the various foundering biotech corporations that entice activist stress, BioMarin really makes cash, and its different lately authorized medication, a remedy for the commonest explanation for dwarfism, is on tempo to turn into its biggest-ever product.
GSK desires extra ADCs
This has been the yr of the antibody-drug conjugate, a cancer-treating expertise with an extended historical past that’s instantly en vogue among the many world’s largest pharmaceutical companies. That features GSK, which signed one other multibillion-dollar deal to increase its pipeline of ADCs.
The corporate mentioned yesterday that it’s going to pay $185 million to Chinese language drugmaker it to collaborate on an early-stage remedy for lung and different cancers. The deal, price as much as $1.5 billion, follows an identical settlement between the 2 corporations disclosed earlier this yr.
The promise of ADCs — which pair tumor-killing chemotherapies with focused antibodies — has led to billions of {dollars} in dealmaking in 2023 alone. Among the many highlights are Bristol Myers Squibb’ $8.4 billion deal for the rights to an ADC from a non-public agency known as SystImmune, Merck’s settlement to pay as much as $22 billion to associate on three compounds from Daiichi Sankyo, and Pfizer’s pending $43 billion acquisition of Seagen, a pioneer within the house.
Can gene remedy be a joke?
Final weekend, in what is nearly definitely a primary, a biotech milestone turned fodder for “Saturday Evening Stay.” The joke, staged at an workplace reward change, is that this: A white worker provides up Casgevy, the remedy, from Vertex Pharmaceutical and CRISPR Therapeutics, that seems to treatment sickle cell illness, which predominantly impacts Black individuals. Her Black colleague is grateful, however then swaps it for a singing, trumpet-playing Santa figurine, and laughter ensues.
However as STAT Jason Mast reviews, to many within the sickle cell group, there was nothing amusing within the sketch. Because the clip made its means round social media, advocates, sufferers, and medical doctors mentioned it appeared to perpetuate falsehoods and stereotypes that had harmed sickle cell sufferers and held again progress for many years. Particularly, that sickle cell was strictly a “Black illness,” and that sufferers didn’t or couldn’t make accountable selections about their very own illness — that they might, for instance, select a Santa toy over a healing remedy.
“To see sickle cell as a joke — it was very distressing,” mentioned Mary Brown, director of the Sickle Cell Illness Basis. “I’ve seen individuals die. I’ve been to too many funerals.”
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The FDA would possibly lastly act on trial range
For years, researchers have identified that newly authorized medication are not often studied in affected person teams that resemble the precise U.S. inhabitants, creating scientific and societal issues in medication. Subsequent yr, the FDA has an opportunity to do one thing about it.
As STAT’s John Wilkerson reviews, a while within the subsequent yr, drug and medical gadget corporations are legally required to current the FDA with plans to diversify their medical trials. That’s a part of a legislation, handed in 2022, meant to twist the trade’s arm into gathering extra information from sufferers who would possibly in the end use their merchandise.
To some advocates, the query is whether or not the FDA will maintain corporations to their guarantees — and the way a lot authority the company has to take action.
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Extra reads
- SEC prices former CEO of ache aid gadget firm with $41 million fraud, STAT
- GlaxoSmithKline pulls again inhaler patents after FTC warning letter, Bloomberg
- French drugmaker Servier ordered to pay $471 million for Mediator scandal, Reuters