Eu­ro­pean reg­u­la­tors ac­cept Fi­bro­Gen's ane­mia drug for re­view; Pas­sage Bio's lead gene ther­a­py gets more love from the FDA

→ It’s ap­proved in Chi­na and Japan, the FDA plans to make its de­ci­sion by De­cem­ber and now the EMA has ac­cept­ed Fi­bro­Gen‘s ane­mia drug, rox­adu­s­tat, for re­view. The de­vel­op­ment trig­gered a mile­stone pay­ment of $130 mil­lion by part­ner Astel­las to Fi­bro­Gen. The drug is en­gi­neered to stim­u­late the pro­duc­tion of red blood cells by mim­ic­k­ing the ef­fect of high al­ti­tude in hu­mans.

Pas­sage Bio, which works close­ly with Jim Wil­son’s Gene Ther­a­py Pro­gram at the Uni­ver­si­ty of Penn­syl­va­nia, has se­cured the FDA‘s rare pe­di­atric dis­ease des­ig­na­tion for its lead ex­per­i­men­tal ther­a­py, PBGM01, broad­ly for the treat­ment of a lyso­so­mal stor­age dis­ease called GM1 gan­gliosi­do­sis. The ther­a­py has al­so been grant­ed or­phan drug sta­tus by the agency. A Phase I/II study in in­fan­tile GM1 pa­tients is ex­pect­ed to kick off in the fourth quar­ter, Pas­sage Bio said.

→ A pact be­tween Syn­log­ic and Ab­b­Vie inked in 2015 has been ter­mi­nat­ed. Un­der the deal, Ab­b­Vie agreed to pay Syn­log­ic $2 mil­lion up­front, and $16.5 mil­lion in mile­stone pay­ments to de­vel­op a treat­ment of in­flam­ma­to­ry bow­el dis­ease. Syn­log­ic’s tech­nol­o­gy is de­signed to ge­net­i­cal­ly en­gi­neer pro­bi­ot­ic mi­crobes to per­form or de­liv­er crit­i­cal func­tions miss­ing or dam­aged due to dis­ease.

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.

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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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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Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal.

Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions.

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.

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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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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