GSK makes a lit­tle his­to­ry while out­lin­ing a fa­mil­iar fu­ture

Glax­o­SmithK­line made phar­ma his­to­ry to­day by ap­point­ing Em­ma Walm­s­ley as the first woman to run a glob­al drug mak­er. And she will have to mea­sure up to the best in the busi­ness if GSK is to break out of the rut it finds it­self in.

The phar­ma gi­ant made some ma­jor turns un­der An­drew Wit­ty: swap­ping can­cer drugs for vac­cines and cash with No­var­tis, in­sist­ing on adopt­ing an eth­i­cal stance in con­sumer sales and break­ing up its re­search teams in­to small­er, more ag­ile units.

But af­ter eight years un­der Wit­ty, the com­pa­ny’s pipeline — aside from some res­pi­ra­to­ry and HIV work — is the least ex­cit­ing among the big 10. The small­er teams failed to pro­duce the grand slams that are need­ed to sus­tain a glob­al gi­ant. The eth­i­cal stance was over­tak­en by a world-class bribery scan­dal in Chi­na. Vac­cines are an un­ex­cit­ing al­ter­na­tive to can­cer, par­tic­u­lar­ly at this stage of the on­col­o­gy rev­o­lu­tion. And rather than sig­nal­ing a new day with a change-up in the R&D strat­e­gy, Walm­s­ley’s most re­cent in­sid­er role as CEO of con­sumer health will spot­light its con­tin­u­a­tion of many of the same themes that land­ed the com­pa­ny in this spot.

In an in­ter­view post­ed on the com­pa­ny’s web­site, Walm­s­ley struck all the ex­pect­ed notes. A mar­ket­ing spe­cial­ist who com­plet­ed a 17-year stint at L’Ore­al, Walm­s­ley won’t have any trou­ble with cor­po­rate lan­guage. Com­mon themes: Pa­tients come first. Meds must be dif­fer­en­ti­at­ed. The staff is ex­cep­tion­al. And so on. But at this stage of the game, GSK may need to think about learn­ing a new script if it ex­pects to win back in­vestors.

GSK be­longs to a block of Big Phar­mas, like Roche, which have large­ly shunned the M&A route. Un­like Roche — which has en­joyed a string of big drug ap­provals from Genen­tech and is lin­ing up a pos­si­ble mega­suc­cess with the MS drug ocre­lizum­ab — GSK isn’t on any­one’s list of R&D lead­ers.

Bar­ring a bold new vi­sion in R&D in a com­pa­ny that spends $4.5 bil­lion a year on drug re­search, the new CEO’s first task may well be re­turn­ing to a com­mon ques­tion: Should GSK break up? The bet­ting now, though, is that an in­sid­er like Walm­s­ley will be un­like­ly to split things up. That leaves its com­mit­ment to a fat div­i­dend as the one tried and true strat­e­gy to keep in­vestors con­tent with its lack of per­for­mance else­where.

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.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

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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