FDA to fol­low EMA with move from Lon­don to Am­s­ter­dam

As the FDA now com­mu­ni­cates with its Eu­ro­pean coun­ter­parts on a dai­ly ba­sis, the US agency has de­cid­ed to make the move from Lon­don to Am­s­ter­dam along­side the EMA.

An­na Abram

“By main­tain­ing an of­fice in both Brus­sels and Lon­don (even­tu­al­ly Am­s­ter­dam), we can bet­ter lever­age our re­sources and col­lab­o­rate with our reg­u­la­to­ry part­ners on high­er-risk sites around the globe that sell food and med­ical prod­ucts to both Eu­rope and the Unit­ed States,” the FDA’s An­na Abram and Mark Ab­doo wrote in a blog post Thurs­day.

Ac­cord­ing to the EMA’s time­line for track­ing their re­lo­ca­tion, the per­ma­nent build­ing in Am­s­ter­dam will be ful­ly op­er­a­tional by 15 No­vem­ber 2019 and staffers will re­lo­cate by 31 De­cem­ber 2019.

Mark Ab­doo

The FDA’s pres­ence in for­eign coun­tries has ex­pand­ed since open­ing its first of­fice in Bei­jing in No­vem­ber 2008. Ad­di­tion­al for­eign of­fices are in New Del­hi (to bet­ter track ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API), raw ma­te­ri­als, fin­ished drugs and var­i­ous food prod­ucts in­clud­ing spices); Brus­sels (the head­quar­ters of the EU); and Lon­don — soon to be Am­s­ter­dam (the head­quar­ters of EMA), among oth­ers.

As of 14 Au­gust, the FDA told Fo­cus that the FDA’s In­dia of­fice has 14 US di­rect hires on staff (of which six are cur­rent­ly de­ployed to In­dia while oth­ers await de­ploy­ment) and five lo­cal­ly em­ployed staff. But not all In­dia-based of­fice em­ploy­ees are in­ves­ti­ga­tors, and In­dia of­fice staff who per­form in­spec­tions share the in­spec­tion­al bur­den with FDA in­ves­ti­ga­tors based in the US who trav­el to In­dia on tem­po­rary as­sign­ments.

The FDA’s Chi­na of­fice as of 14 Au­gust had 20 US di­rect hires on staff, with six wait­ing de­ploy­ment and six lo­cal­ly em­ployed staff. That com­pares with a pre­vi­ous tal­ly from De­cem­ber 2015 of 17 em­ploy­ees as­signed to its Bei­jing of­fice. But as with In­dia, not all Chi­na Of­fice em­ploy­ees are in­ves­ti­ga­tors, and Chi­na staff that per­form in­spec­tions share the in­spec­tion­al bur­den with US-based in­ves­ti­ga­tors de­ployed on tem­po­rary as­sign­ments, the FDA said.

“To­day, our ap­proach to in­for­ma­tion-gath­er­ing and shar­ing has be­come an im­por­tant func­tion of our for­eign of­fices. They feed in­for­ma­tion in­to Pre­dic­tive Risk-based Eval­u­a­tion for Dy­nam­ic Im­port Com­pli­ance Tar­get­ing (PRE­DICT), a risk-based tool de­vel­oped by FDA to screen all reg­u­lat­ed ship­ments im­port­ed or of­fered for im­port in­to the Unit­ed States. Our for­eign of­fices al­so use Glob­al Watch for com­mu­ni­cat­ing with FDA Cen­ters and our Of­fice of Reg­u­la­to­ry Af­fairs about emerg­ing trends rel­e­vant to the agency’s pub­lic health mis­sion,” Abram and Ab­doo write.

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.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.