When asked directly on Gilead’s recent earnings call whether the company expects to profit from remdesivir — the only antiviral to have generated positive clinical data on a randomized, placebo-controlled trial and earned Anthony Fauci’s endorsement as a standard-of-care — Daniel O’Day was careful not to commit.

“(T)here is no guide book out there, there is no rule book out there,” the CEO said, pledging only to be “very thoughtful” about providing access.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN