There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Galera was sure it had a winner when it launched its pivotal severe oral mucositis (SOM) trial back in 2018 — and so were investors. Fresh off a $150 million raise, the company plunged headfirst into Phase III, even making commercial plans.

But those plans went splat Tuesday, as an unexpected failure sent shares spiraling into penny stock territory.

Galera’s lead candidate avasopasem (also known as GC4419) failed to significantly reduce the incidence of SOM in patients with locally advanced head and neck cancer compared to placebo, the company announced. While those in the treatment group saw a slight reduction, 54% compared to 64% in the placebo group, the endpoint failed to achieve statistical significance (p=0.113).

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

When Merck announced this month that its Covid-19 pill cut newly diagnosed patients’ risk of being hospitalized by 50%, researchers and analysts hoped that other pills would soon prove similarly effective. They paid particular attention to two drugs from Pfizer and Roche.

But on Tuesday, Roche and its biotech partner, Atea, announced that their antiviral had failed a key interim test.

In a Phase II trial, AT-527 didn’t reduce the amount of virus in mild to moderate Covid-19 patients any more than a placebo pill did. That was true for both the patients who received a high dose and those who received the low dose.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN