Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

When AstraZeneca started the Phase III AEGEAN trial for Imfinzi in 2018, it was, alongside several Big Pharma brethren, hoping to push the use of PD-(L)1 therapies into earlier lines of treatment. Three and a half years later, the British drugmaker has nabbed promising data in a type of lung cancer.

Topline results from an interim analysis showed that adding Imfinzi to chemotherapy before surgery spurred a “statistically significant and meaningful” improvement in pathologic complete response for patients with resectable non-small cell lung cancer compared to chemotherapy alone.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

After downsizing for several months, Catalyst Biosciences is getting ready to tap out.

The San Francisco biotech announced Wednesday that it would be liquidating and distributing cash back to shareholders, with total proceeds expected to reach $65 million. Catalyst intends to return the money “as soon as practicable,” the company said, as it has ceased all R&D activities, CEO Nassim Usman said in a statement.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN