The End­points poll: Clin­ton v Trump and wide­spread fret­ting that the FDA just blun­dered bad­ly

Who would be a bet­ter pres­i­dent  for biotech? Hillary Clin­ton or Don­ald Trump? Is there even a dif­fer­ence? And what did the in­dus­try think of that con­tro­ver­sial Duchenne mus­cu­lar dy­s­tro­phy drug ap­proval? Did it mark a drop in FDA stan­dards? We asked our au­di­ence and heard back — loud and clear.

End­points News pulled off its first snap poll at the end of last week, with pub­lish­er Ar­salan Arif send­ing out a sin­gle query to a tar­get­ed seg­ment from our 10,000 email sub­scribers. About 95% of our au­di­ence is di­rect­ly en­gaged in the bio­phar­ma busi­ness, with a big fo­cus on drug de­vel­op­ment. Our goal: get a sense of the in­dus­try’s think­ing on pres­i­den­tial pol­i­tics and that re­cent con­tro­ver­sial FDA OK for the Duchenne drug eteplirsen.

The re­spons­es came in hard and fast, leav­ing lit­tle doubt how the ma­jor­i­ty is feel­ing on both is­sues. Al­to­geth­er, Arif col­lect­ed 494 re­spons­es from qual­i­fied bio­phar­ma in­dus­try pro­fes­sion­als.

1. Who would be the bet­ter Pres­i­dent for the bio­phar­ma in­dus­try? (Please, no per­son­al feel­ings.)

Hillary Clin­ton 52% 259
Don­ald Trump 27% 134
No dif­fer­ence 20% 101
To­tal 494

First, on the elec­tion. Rather than sim­ply ask who peo­ple are plan­ning to vote for, we went for a some­what dif­fer­ent take. Who do you think will most like­ly be bet­ter for biotech? Don­ald Trump or Hillary Clin­ton? A slight, over­all ma­jor­i­ty marked Clin­ton as the bet­ter of the two can­di­dates for the in­dus­try. Trump came in at about half that num­ber. And he beat out “no dif­fer­ence” by a mere 7 points, with 1 in 5 fail­ing to see any kind ad­van­tage in one over the oth­er.

Clin­ton may be win­ning the biotech vote, but with so many dis­af­fect­ed pro­fes­sion­als un­able to mark a pref­er­ence, you can’t say that any kind of ma­jor­i­ty is over-the-moon about the idea of a Clin­ton pres­i­den­cy. Trump, though, is a dis­tant sec­ond in the hearts of the biotech in­dus­try. Come the No­vem­ber elec­tion, Clin­ton takes the biotech vote — heav­i­ly clus­tered in De­mo­c­ra­t­ic strong­holds like Boston and the Bay Area — in a cake walk.

2. Should the FDA have ap­proved Ex­ondys 51/eteplirsen?

All Clin­ton + Trump + No diff.
No 66% (324) 67% (173) 65% (87) 63% (64)
Yes 34% (170) 33% (86) 35% (47) 37% (37)

There’s no doubt­ing how to in­ter­pret these num­bers. Two thirds of the peo­ple we polled felt that the FDA should not have ap­proved Sarep­ta’s Ex­ondys 51 (eteplirsen). This was a non-par­ti­san fa­vorite. There was vir­tu­al­ly no dif­fer­ence on which way they leaned on the pres­i­den­tial show­down, ei­ther. Whether they thought Trump or Clin­ton was bet­ter for biotech, the ma­jor­i­ty clear­ly felt that the agency had made a mis­take.

Sarep­ta helped fo­ment one of the biggest pa­tient ad­vo­ca­cy cam­paigns ever mount­ed for an ap­proval. But sev­er­al top FDA of­fi­cials made it clear that the com­pa­ny had nev­er suc­cess­ful­ly made its case for this drug. FDA Com­mis­sion­er Robert Califf al­so cit­ed the com­pa­ny for play­ing fast and loose with some of the da­ta the com­pa­ny used to make its case with pa­tients and in­vestors. But he bowed to the de­ci­sion made by CDER di­rec­tor Janet Wood­cock. And that, says the ma­jor­i­ty, was a mis­take.

3. Did the ap­proval of Ex­ondys 51/eteplirsen mark a drop in the FDA’s stan­dards?

All Wrong ap­proval Right ap­proval
Yes 68% (337) 92% (299) 22% (38)
No 32% (157) 8% (25) 78% (132)

Rough­ly the same num­ber of in­dus­try pros who ob­ject­ed to the ap­proval al­so con­clud­ed that the con­di­tion­al ap­proval for mar­ket­ing marked a drop in the agency’s stan­dards. It is note­wor­thy, though, that 22% of the in­dus­try pro­fes­sion­als who felt it was the right de­ci­sion al­so felt that it marked a drop in ap­proval stan­dards. A much small­er per­cent­age of the “wrong” vote – 8% – did not feel that it re­flect­ed a drop in stan­dards.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.