EMA to lose 25% of staff as hard Brex­it ap­proach­es

As UK Prime Min­is­ter There­sa May’s Brex­it deal is ex­pect­ed to be re­ject­ed Tues­day in a House of Com­mons vote, the EMA has said that af­ter close­ly mon­i­tor­ing staffers’ in­ten­tions to re­lo­cate to Am­s­ter­dam, it cur­rent­ly ex­pects a staff loss of about 25%.

The 25% fig­ure might seem like a lot of staffers to lose (about 225 of 900 lost), but that fig­ure is on the low end of pre­dic­tions from a sur­vey in Sep­tem­ber 2017 that found EMA ex­pect­ed to lose at least 19% of its staffers no mat­ter which city was se­lect­ed.

In ad­di­tion to the staffing loss­es, EMA said it will fur­ther tem­porar­i­ly re­duce or sus­pend ac­tiv­i­ties in the first half of 2019 as it moves in­to the fi­nal phase of its phys­i­cal re­lo­ca­tion. EMA said it will launch such mea­sures as part of a fourth and fi­nal phase of the busi­ness con­ti­nu­ity plan as of 1 Jan­u­ary.

For in­stance, be­tween 11 Feb­ru­ary and 15 March 2019, no pre-sub­mis­sion meet­ings for ini­tial mar­ket­ing au­tho­riza­tion ap­pli­ca­tions will take place, while EMA moves to its new premis­es. EMA will al­so not print or dis­patch cer­tifi­cates for phar­ma­ceu­ti­cal prod­ucts from 25 Feb­ru­ary un­til 14 March 2019, though com­pa­nies can still sub­mit re­quests dur­ing this pe­ri­od, which EMA will con­tin­ue to process.

“Tem­po­rary sus­pen­sion and scal­ing back of ac­tiv­i­ties is cur­rent­ly sched­uled to last un­til 30 June 2019. Cur­rent staffing pro­jec­tions should al­low EMA to grad­u­al­ly re­sume these ac­tiv­i­ties as of Ju­ly 2019. EMA will re­view this in April 2019, once it has moved to its tem­po­rary build­ing in Am­s­ter­dam,” EMA said.

And staff re­lo­ca­tion to the per­ma­nent build­ing is slat­ed to be fi­nal­ized by 31 De­cem­ber 2019.

The agency said that de­spite the halt­ing of cer­tain ac­tiv­i­ties, it ex­pects all core ac­tiv­i­ties re­lat­ed to the eval­u­a­tion and su­per­vi­sion of med­i­cines “to con­tin­ue with­out any in­ter­rup­tion or de­lays fore­seen and to the same qual­i­ty.”

The agency al­so said it will pro­vide more in­for­ma­tion on this fourth phase of the con­ti­nu­ity plan and its ac­tiv­i­ties dur­ing this crit­i­cal pe­ri­od short­ly.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Left to right, top to bottom: Carl Gordon, Adam Stone, Peter Moglia, David Schenkein, Robert Nelsen, Carol Gallagher; Srinivas Akkaraju, Ray Debbane, Jim Flynn, Peter Kolchinsky, Thilo Schroeder, Brad Bolzon

The top 100 bio­phar­ma ven­ture in­vestors at the mega­bil­lions deal ta­ble

The VC crowd took a step back last year, but nevertheless maintained a furious pace of new investments in therapeutic tech platforms and biotech startups. And the top 100 players completely dominated the megabillions game.

Just looking at the number of deals done by each of the top 100, OrbiMed came in at the top, with 20, followed by Alexandria (18), Perceptive (16) and the ubiquitous RA Capital at 16. It’s impossible to say exactly how much they invested in total — those numbers are only rarely provided — but it is clear from the numbers assembled by Chris Dokomajilar at DealForma who’s most likely to be found sitting at the table during the go-go days of biotech investing.

Dokomajilar tracked $14.06 billion in biotech venture investing last year, a dip from the frenzied pace of $16.02 billion in 2018 and more than $10 billion higher than he recorded for 2010, as the economy was recovering from a profound economic crisis.

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Rahul Ballal, Imara

As sick­le cell pa­tients find new op­tions, NEA-found­ed Imara pitch­es mid-stage al­ter­na­tive for $86M IPO

November 2019 proved to be a fruitful month for patients with blood disorders known as hemoglobinopathies. Within days, the FDA ushered two drugs for sickle cell disease and another for beta thalassemia to the market — livening up a barren field.

Imara, a relatively young plower, is riding on that enthusiasm as it shoots for an $86.25 million IPO.

Imara emerged from New Enterprise Associates’ orphan drug accelerator Cydan in 2016 as a single-product company. $77.3 million in private financing later IMR-687 remains the sole asset in its pipeline; the difference is the drug is now in Phase II for sickle cell disease, with topline data slated for later this year and two other mid-stage beta thalassemia studies lined up.

RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Beijing-based rare disease and oncology player has raised $98 million to help fund the expansion of its pipeline as well as a commercial portfolio.

CANbridge put out word Tuesday that the global private equity player General Atlantic joined forces with Chinese CRO Wuxi AppTec to lead the Series D, with both ready to chip in an extra $10 million each under the right conditions. The syndicate includes RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed.

Carol Robinson, Professor Dame Carol Robinson Research Group

Drug dis­cov­ery in HD: Ox­ford spin­of­f's mass spec­trom­e­try ap­proach scores fresh fund­ing

The technology used to detect explosives at airports — mass spectrometry — is being piloted as an engine for drug discovery.

Mass spectrometry is a tool designed to measure with profound accuracy the mass of a single molecule. Typically, mass spectrometers can be used to identify unknown compounds, to quantify known compounds, and to determine the structure and chemical properties of molecules.

UP­DAT­ED: Chi­na ap­proves flu drug be­ing tout­ed as a po­ten­tial coro­n­avirus treat­ment amid a rush of clin­i­cal stud­ies

One of the three drugs that China’s Ministry of Science and Technology has tapped as potential COVID-19 treatments to watch has notched its first Chinese OK — for the flu.

While there’s no proof yet that fapilavir, or favipiravir, is the cure that patients and physicians are yearning for, it stands out for a unique constellation of qualities. It’s been commercially available in Japan for several years (unlike Gilead’s experimental remdesivir) yet it’s new to China (unlike the malaria drug chloroquine phosphate). Perhaps more importantly, a domestic biotech — Zhejiang Hisun Pharma — owns the rights to manufacture and market the drug, preempting any concerns about patents.

FDA goes on high alert as coro­n­avirus rais­es threat to drug man­u­fac­tur­ing and clin­i­cal tri­als grind to a halt

The FDA isn’t quite sure just what the coronavirus outbreak in China will mean for the US pharma industry, but it has the potential to trigger a host of troublesome issues around the supply chain the country is directly plugged into.

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Warren Buffett, AP Images

War­ren Buf­fett gets a dou­ble take as the in­vest­ment pow­er­house set­tles on its first biotech in­vest­ment

Coke. American-Express. Apple. And Biogen?

Warren Buffet’s Berkshire Hathaway, which made itself into a symbol of rock-solid investment strategy, has revealed a stake in the big biotech as it takes on one of the biggest gambles in the industry.

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For­mer No­var­tis ex­ec pleads guilty to gener­ic price fix­ing

On Friday, Hector Armando Kellum — a former senior executive at Novartis’ Sandoz unit plead guilty to charges of conspiring to fix the prices of products, including eczema and psoriasis treatment clobetasol and anti-fungal therapy nystatin triamcinolone, the Justice Department said.

His alleged partners-in-crime included Ara Aprahamian, a former sales and marketing executive at Taro Pharmaceutical Industries, who was also indicted in Philadelphia earlier this month for price-fixing and bid-rigging.