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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Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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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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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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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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