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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.