Roche CEO Severin Schwan (Image: Reuters/Arnd Wiegmann)

FTC staff signs off on Roche $4.3B deal for Spark — re­port

Roche is one step clos­er to reg­u­la­to­ry en­dorse­ment — in the form of an FTC staff rec­om­men­da­tion — to buy Spark Ther­a­peu­tics with­out any as­set sales, ac­cord­ing to a re­port by the Capi­tol Fo­rum on Thurs­day.

Con­cerns that the Swiss drug­mak­er may be forced to aban­don a he­mo­phil­ia gene ther­a­py be­ing de­vel­oped by Spark in or­der to con­sum­mate the $4.3 bil­lion ac­qui­si­tion, erupt­ed af­ter the Fed­er­al Trade Com­mis­sion (FTC) is­sued a sec­ond re­quest for in­for­ma­tion in June. A sec­ond re­quest is rare and typ­i­cal­ly au­gurs a di­vesti­ture de­mand, ac­cord­ing to an analy­sis by Mizuho Se­cu­ri­ties an­a­lyst Difei Yang last month.

“The FTC has not filed a com­plaint in this mat­ter, and the agency doesn’t sign off on deals. It ei­ther files a com­plaint or it doesn’t,” an FTC spokesper­son told End­points News on Fri­day.

If the re­port from Wash­ing­ton DC-based out­let Cap­i­tal Fo­rum is ac­cu­rate, the FTC chair­man and four com­mis­sion­ers must al­so back the deal be­fore it can be com­plet­ed.

Ear­li­er this week, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty in­di­cat­ed that it has sched­uled a dead­line of De­cem­ber 16 for its Phase I de­ci­sion. If the re­view goes in­to Phase II, a more com­pre­hen­sive probe will kick off.

In its third-quar­ter re­sults up­date last week, Roche $RHB­BY chief Sev­erin Schwan re­it­er­at­ed he was con­fi­dent the deal — which was un­veiled in Feb­ru­ary and has seen de­lay af­ter de­lay — would be com­plet­ed by year-end.

Roche’s pro­phy­lac­tic treat­ment for pa­tients with he­mo­phil­ia A, Hem­li­bra, has been gen­er­at­ing healthy sales. Spark Ther­a­peu­tics $ONCE — the mak­er of the first gene ther­a­py in the Unit­ed States, a prod­uct for an in­her­it­ed form of blind­ness — has two gene ther­a­pies in de­vel­op­ment for he­mo­phil­ia A, in­clud­ing the late-stage drug SPK-8011, as well as a phase I/II pro­gram for SPK-8016.

Roche and Spark de­clined to com­ment.

Spark shares $ONCE closed up about 7.5% on Thurs­day at $108.64.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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