A year in­to Al­bert Bourla’s reign, Ian Read leaves all of Pfiz­er in the new CEO’s con­trol

Ian Read is of­fi­cial­ly bow­ing out of Pfiz­er.

Af­ter a brief stint as ex­ec­u­tive chair­man — su­per­vis­ing his suc­ces­sor Al­bert Bourla’s first year as CEO — Read is re­tir­ing at the end of the year and turn­ing over the chair­man role to Bourla. De­cem­ber 31, 2019 will mark the con­clu­sion of Read’s 41 years at the phar­ma gi­ant $PFE.

Bourla is gath­er­ing the reins amid a flur­ry of ac­tion to re­shape Pfiz­er in­to a “small­er, more fo­cused, sci­ence-based com­pa­ny with a sin­gu­lar fo­cus on in­no­v­a­tive phar­ma.” Weeks ago the com­pa­ny re­vealed plans to com­bine its off-patent drug busi­ness, Up­john, with My­lan — fol­low­ing an ear­li­er deal to spin off its con­sumer health unit in­to a joint ven­ture with Glax­o­SmithK­line.

Read — a vo­cal rep­re­sen­ta­tive of the in­dus­try, who’s un­afraid to de­fend his some­what con­tro­ver­sial views on things like megamerg­ers and drug price hikes but al­so open to chang­ing his mind — said he be­lieves “Pfiz­er’s best days are yet to come.”

It is now up to Bourla, a vet­eri­nar­i­an by train­ing who joined Pfiz­er in 1993 and be­came COO in 2017, to ex­e­cute on a new vi­sion that in­volves dou­bling down on the in­ter­nal late-stage as­sets while keep­ing an eye on bolt-on M&A deals to re­plen­ish the ear­ly- and mid-stage pipeline.

In his send­off for Read, the new chair­man and CEO heaped praise on his men­tor:

I want to thank Ian for his un­wa­ver­ing ded­i­ca­tion to Pfiz­er over the past four decades and dur­ing this lead­er­ship tran­si­tion. As a re­sult of his un­re­lent­ing fo­cus on cul­ture, cre­at­ing val­ue and de­vel­op­ing tal­ent, Pfiz­er has be­come a stronger and more sta­ble in­sti­tu­tion. His lead­er­ship and coun­sel have been in­valu­able to the com­pa­ny, and more per­son­al­ly, I have ben­e­fit­ed great­ly from Ian’s ad­vice, guid­ance and friend­ship.

The tran­si­tion “is the re­sult of a sys­temic and com­pre­hen­sive suc­ces­sion plan un­der­tak­en by the board sev­er­al years ago,” added Shan­tanu Narayen, the lead in­de­pen­dent di­rec­tor on the board.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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