Emer Cooke at the European Headquarters of the United Nations, Geneva, Switzerland, November 13, 2019 (Martial Trazzini/Shutterstock)

EMA nom­i­nates Emer Cooke as ex­ec­u­tive di­rec­tor to re­place Gui­do Rasi

The EMA’s man­age­ment board on Thurs­day nom­i­nat­ed Emer Cooke from a short list of can­di­dates to suc­ceed Gui­do Rasi as the agency’s next ex­ec­u­tive di­rec­tor.

Gui­do Rasi

Rasi, whose sec­ond term as EMA ex­ec­u­tive di­rec­tor ends on No­vem­ber 15, served as Ex­ec­u­tive Di­rec­tor from 2011-2014 be­fore be­ing forced to step down af­ter the Eu­ro­pean Union Civ­il Ser­vice Tri­bunal an­nulled his ap­point­ment.

With the nom­i­na­tion in hand, Cooke is set to ad­dress the Eu­ro­pean Par­lia­ment’s Com­mit­tee on En­vi­ron­ment, Pub­lic Health and Food Safe­ty (EN­VI) on 13 Ju­ly 2020 be­fore her for­mal ap­point­ment can pro­ceed. Once ap­point­ed, Cooke will be the fourth ex­ec­u­tive di­rec­tor in EMA’s 25-plus year his­to­ry.

Cooke is cur­rent­ly the di­rec­tor of the Reg­u­la­tion and Pre­qual­i­fi­ca­tion De­part­ment at the WHO, where she leads the in­ter­na­tion­al agency’s work on health tech­nol­o­gy reg­u­la­tion, stan­dards, pre­qual­i­fi­ca­tion and reg­u­la­to­ry sys­tems strength­en­ing.

Be­fore her work at the WHO, Cooke be­gan her ca­reer as a reg­u­la­tor in 1988 as a phar­ma­ceu­ti­cal as­ses­sor at Ire­land’s for­mer Na­tion­al Drugs Ad­vi­so­ry Board be­fore mov­ing to the Eu­ro­pean Fed­er­a­tion of Phar­ma­ceu­ti­cal In­dus­tries and As­so­ci­a­tions (EF­PIA). From 1998-2002, Cooke worked for the Eu­ro­pean Com­mis­sion’s phar­ma­ceu­ti­cals unit be­fore a long stint at EMA through 2016. Dur­ing her tenure at EMA, Cooke served as head of in­spec­tions and head of in­ter­na­tion­al af­fairs, among oth­er po­si­tions.

Cooke’s ed­u­ca­tion­al back­ground in­cludes a de­gree in phar­ma­cy, as well as mas­ter’s de­grees in sci­ence and busi­ness ad­min­is­tra­tion, from Trin­i­ty Col­lege in Dublin, Ire­land.


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Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Francis deSouza, Illumina CEO (Stefan Wermuth/Bloomberg via Getty Images)

Il­lu­mi­na chair­man oust­ed from board as ac­tivist in­vestor Ic­ahn wins par­tial vic­to­ry

Illumina’s chairman has been ousted from the company’s board, a partial win for activist investor Carl Icahn, who is still likely to put the future leadership and direction of the DNA sequencing giant into question.

The vote to remove chairman John Thompson and put in Andrew Teno was the climax of a proxy fight brought by Icahn after Illumina’s stock slide and decision to buy the cancer-testing company Grail. Illumina said a new chair will be chosen in the coming weeks.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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