Next month John Car­roll and the End­points ed­i­to­r­i­al team con­tin­ue a proud tra­di­tion of pro­fil­ing a stand­out group of 11 star­tups that just might be head­ed for great­ness. And we’re adding a new, live el­e­ment that we want to share with all of you — and we’re ask­ing for just one hour of your time.

Please mark your cal­en­dars for a 1-hour main event on Sep­tem­ber 30 at 4pm ET. The agen­da will ex­pand in the com­ing weeks, and we’ll have more than one hour’s worth of con­tent for you. But the cen­ter­piece of the 2020 End­points 11 is a one-hour live-streamed event.

It will start at 4pm ET / 1pm PT, and you can sign up with this link.

Our goal is to cel­e­brate bold sci­ence in the pur­suit of new biotech drugs, and that’s a lot eas­i­er said than done. When it comes to pick­ing pri­vate com­pa­nies, we’re deal­ing with in­com­plete and im­per­fect in­for­ma­tion. And the lim­its of our cur­rent un­der­stand­ing of bi­ol­o­gy can frus­trate the most ex­pe­ri­enced sci­en­tif­ic teams armed with tremen­dous fi­nan­cial back­ing. Re­gard­less, we’re go­ing to make our picks and ar­gue our case for them. The com­pa­nies that are in our sight are all swing­ing for the fences. Some will fail, but they each rep­re­sent a trend in new biotech com­pa­ny cre­ation. And they emerge from a his­tor­i­cal back­drop, with the pan­dem­ic fo­cus­ing the world’s at­ten­tion on bio­phar­ma like nev­er be­fore.

This year we’re spon­sored by Catal­ent, a com­pa­ny that has sup­port­ed our in­de­pen­dent mis­sion at End­points from the start. This year, part of our agen­da fea­tures my co-founder and End­points ed­i­tor John Car­roll pre­sent­ing the awards live to the win­ners along­side Catal­ent CEO John Chimin­s­ki. Both “John C”s have a fun his­to­ry of this kind of work, which we last saw at JP Mor­gan this year in San Fran­cis­co. It’s go­ing to be a lot of fun and I hope you all can be a part of it.

Feel­ing Zoomed out? That’s un­der­stand­able, and we’ll be work­ing to keep your at­ten­tion. There is a gen­uine need to con­tin­ue the kind of cel­e­bra­to­ry events that would bring us to­geth­er in a nor­mal year — and we think this is worth your time. There’s more than one hour’s worth of con­tent to share with you all, but the ex­pe­ri­ence will be shaped in a way where the live show is the cen­ter­piece. Every­thing else is on-de­mand. And there’s no cost to at­tend. You can sign up here.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.