Does Bristol Myers care about Celgene shareholders?

For investors in Celgene, Bristol Myers Squibb’s $74 billion acquisition brought a one-time windfall of cash and the promise of more down the line, provided three of the company’s drugs progressed on schedule. Nearly 18 months later, that second payout is in peril, seeding doubts about Bristol Myers’ execution.

As STAT’s Matthew Herper reports, the latest problem is tied to ide-cel, a cancer therapy partnered with Bluebird Bio that needs to win FDA approval by March 21, 2021, for Celgene shareholders to see a reward. The FDA refused to even consider the application, a rare setback that could delay approval by months or more.

That comes a week after JCAR017, another former Celgene cancer drug, endured a three-month delay to its FDA timeline. It’s now up for approval in November, one month before the deadline for Celgene shareholders. The third drug, a treatment for multiple sclerosis, already met its goal.

Whether Bristol Myers executives get their full bonuses is in part tied to whether the company hits its Celgene timelines, but the mounting regulatory issues have shareholders concerned that their wallets may not be top of mind for the combined company.

Read more.

Allogene’s off-the-shelf CAR-T shows early promise

Allogene, from the CAR-T pioneers behind Kite Pharma, is at work on cancer-killing cell therapies that could be available on demand, rather than custom-made from each patient. And in a first look at preliminary data, the richly valued company appears to be on track.

As STAT’s Adam Feuerstein reports, Allogene reported an impressive response rate for its off-the-shelf CAR-T therapies in patients with an advanced form of lymphoma. In data from nine patients, seven saw their cancer recede after treatment, and three had no detectable tumor cells. Three of the patients relapsed.

Read more.

The government has data on remdesivir. Why don’t we?

Two weeks ago, the NIH told the world that Gilead Sciences’ remdesivir offered a modest but much-needed benefit to patients with Covid-19, promising to disclose details in the future. Those details remain under wraps, all while doctors and officials the world over are grappling with how to implement remdesivir in dire real-life situations.

To STAT’s Ed Silverman, that’s inexplicable. For all we know, the full remdesivir dataset could be full of caveats that water down the drug’s top-line promise. Conversely, Gilead’s treatment might turn out to appear that much more effective once one considers underlying patient statistics and other undisclosed details.

Without more information, doctors are left to guess, with patients’ lives in the balance. And the government could rectify that by simply making it all public.

Read more.

Microbiomics might treat a common vaginal infection

The nascent field of microbiome therapy has largely focused on deadly cases of C. difficile, but there’s evidence so-called good bacteria can treat a common vaginal infection.

As STAT’s Kate Sheridan reports, a 228-patient trial found that a bacterial treatment from the biotech Osel was statistically significantly better than placebo at reducing the recurrence of bacterial vaginosis, an itchy infection that can predispose women to certain sexually transmitted infections.

The treatment, Lactin-V, is a powder derived from the bacteria Lactobacillus crispatus. Lactin-V has a long pharmaceutical history, having changed hands multiple times over more than 20 years. And it will need to replicate its promise in a larger study before FDA approval becomes a possibility. But if it succeeds, it would be the first major advance for bacterial vaginosis in decades.

Read more.