The End­points 11 cel­e­brates bio­phar­ma's most promis­ing star­tups. Live event on Sep­tem­ber 30

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.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.