Ar­a­digm los­es CEO, CMO and CFO fol­low­ing reg­u­la­to­ry dis­as­ter; Omeros shares go up on pos­i­tive re­sults for blood clot treat­ment

→ As Ar­a­digm $ARDM con­tends with the af­ter­math of a dis­as­trous reg­u­la­to­ry jour­ney, it has let go of three of its top ex­ec­u­tives in an ap­par­ent mea­sure to cut costs. CEO Ig­or Gon­da, CMO Juer­gen Froehlich and CFO Nan­cy Peco­ta have re­signed from all of their po­si­tions at the trou­bled biotech. John Siebert, cur­rent chair­man of the board, will step in as ex­ec­u­tive chair­man and in­ter­im prin­ci­pal ex­ec­u­tive of­fi­cer. If Ar­a­digm wants an­oth­er chance at the FDA for its in­haled an­tibi­ot­ic Lin­haliq, which it in­di­cat­ed it would like to do, it would need fresh cash to fu­el a whole new PhI­II pro­gram.

→ By com­par­ing the per­for­mance of its drug against his­tor­i­cal da­ta in a Phase II study, Omeros has de­clared that OMS721 leads to a sig­nif­i­cant in­crease in me­di­an over­all sur­vival for pa­tients with a type of blood clot as­so­ci­at­ed with stem cell trans­plant. Among a to­tal of 19 hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy (HCT-TMA) pa­tients, the me­di­an OS was 347 days, a big im­prove­ment com­pared to the 21 days record­ed in lit­er­a­ture. The bio­mark­ers al­so looked pos­i­tive to re­searchers. Four deaths oc­curred, dur­ing the study, but the com­pa­ny said on­ly one was pos­si­bly drug-re­lat­ed. Omeros’ shares $OMER edged up 12% in pre-mar­ket trad­ing, slow­ly re­cov­er­ing from a Wednes­day slump that some say were spurred by re­ports that their oth­er drug will lose re­im­burse­ment un­der the new fed­er­al bud­get.

→  Ver­tex Phar­ma $VRTX says its Phase II study of the nono­pi­oid pain drug VX-150 hand­i­ly beat out a place­bo in treat­ing post-sur­gi­cal pain. The suc­cess in Phase II helps clar­i­fy re­searchers’ plans for the next round of stud­ies as it looks to ad­vance a new ap­proach to pain in the mid­dle of an opi­oid ad­dic­tion epi­dem­ic. Their drug clear­ly fell short of a com­para­tor arm of pa­tients giv­en the com­mon­ly pre­scribed opi­oid med­i­cine hy­drocodone+ac­eta­minophen, but may prove good enough as a sub­sti­tute in many cas­es.

→  Switzer­land’s San­thera Phar­ma­ceu­ti­cals (SIX: $SANN) struck a deal with Polyphor to in-li­cense POL6014, a clin­i­cal-stage ther­a­py for cys­tic fi­bro­sis and oth­er neu­trophilic pul­monary dis­eases such as non-cys­tic fi­bro­sis bronchiec­ta­sis, al­pha-1 an­tit­rypsin de­fi­cien­cy and pri­ma­ry cil­iary dysk­i­ne­sia.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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