The hospital’s gone now but across the street from it, there used to be a clinic, a beat-up thing with peeling paint that, in a past life, a past city, had been a bank. John Sundy was a medical student training at the hospital, in downtown Philadelphia. He walked in and saw a crowd of patients in all manner of autoimmune conditions waiting to see a tan, distinguished-looking man in a white lab coat: well-known rheumatologist Ralph DeHoratius.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN