Clin­ton cam­paign staff: "We have start­ed the war with phar­ma!!"

Just one Tweet from Hillary Clin­ton drove biotech stocks down sharply last fall, the open­ing round in what would be a sav­age bear mar­ket for the in­dus­try. And her se­nior staffers in the cam­paign were deliri­ous.

Clin­ton had jabbed Mar­tin Shkre­li hard for his de­ci­sion to jack up the price of Dara­prim by more than 5,000%, and the sharp, swift re­ac­tion on Wall Street to the mes­sage on drug prices was cheered by her se­nior pol­i­cy ad­vis­ers, ac­cord­ing to one of sev­er­al email ex­changes in­clud­ed in Wik­iLeaks hacked John Podes­ta files.

FYI – We have start­ed the war with Phar­ma!!,” ex­claimed Ann O’Leary re­gard­ing the press that fol­lowed. “Great!,” replied out­side ad­vis­er Mandy Grun­wald.

A few weeks lat­er, though, Clin­ton strate­gist Jim Mar­go­lis was be­gin­ning to fret that Shkre­li hadn’t caved on the price.

I’m a lit­tle ner­vous that we ran the spot and this dude is still stick­ing it to pa­tients. Has there been any fur­ther dis­cus­sion about this?

That wouldn’t be the on­ly ex­change re­gard­ing Hillary Clin­ton’s ad­ver­sar­i­al re­la­tion­ship with Big Phar­ma, which was care­ful­ly con­sid­ered in­side her cam­paign.

Last fall, as Hillary Clin­ton’s cam­paign team was sound­ing out var­i­ous po­si­tions that would help high­light her stance on the phar­ma in­dus­try, the nom­i­na­tion of Robert Califf as FDA com­mis­sion­er pre­sent­ed a tempt­ing tar­get to at least one of her top ad­vis­ers.

A New York Times ar­ti­cle had raised the is­sue of Califf’s ties to the in­dus­try, and O’Leary – a se­nior pol­i­cy ad­vis­er – saw it as a po­ten­tial open­ing for a po­lit­i­cal jab that would high­light Hillary Clin­ton’s ea­ger­ness to stand up to Big Phar­ma, ac­cord­ing to one of the hacked emails that emerged in the John Podes­ta files re­leased by Wik­iLeaks.

O’Leary wrote:

Califf the Oba­ma nom­i­nee does have re­al ties to the drug in­dus­try – Chris Jen­nings is call­ing a few peo­ple for me to learn more so we don’t tip our hand di­rect­ly. We are clean on Clin­ton Ad­min FDA Com­mis­sion­er – it was David Kessler, an aca­d­e­m­ic who had run a teach­ing hos­pi­tal – and best known for tak­ing on big to­bac­co.  We could cer­tain­ly sig­nal that we want some­one will­ing to stand up to Phar­ma (in the same way Kessler stood up to To­bac­co).

BUT – I want to do a lit­tle more dig­ging and due dili­gence be­fore we hit this guy.  Hav­ing been through a nom­i­na­tion fight with my hus­band (in which he lost), this is per­son­al and messy and hor­ri­ble on the per­son nom­i­nat­ed and their fam­i­lies – so I don’t take at­tack­ing this guy light­ly.

Clin­ton spokesman Bri­an Fal­lon not­ed that he liked the idea, not­ing that Joe Biden – a po­ten­tial con­tender for the nom­i­na­tion – would be re­quired to be in Califf’s cor­ner.

Any up­date on this? As we con­sid­er fights that fit in­to the larg­er themes we are try­ing to pro­mote, this seems like a good fight to have.

Plus, the VP would be in a box of hav­ing to sup­port this nom­i­nee.

The email ex­change even­tu­al­ly pe­ters out, but it does un­der­score that Clin­ton all along in­tend­ed to help dis­tin­guish her can­di­da­cy by crit­i­ciz­ing the phar­ma in­dus­try, a po­si­tion that fell more nat­u­ral­ly in­to her lap when Mar­tin Shkre­li was be­ing pil­lo­ried for rais­ing the price of an old gener­ic drug more than 5,000%.

(Shehla Shakoor con­tributed to this sto­ry.)

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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