Bris­tol My­ers re­ports short­age of chemo drug abrax­ane; Sar­to­rius more than dou­bles ca­pac­i­ty with Michi­gan ex­pan­sion

Man­u­fac­tur­ing de­lays have led to a short­age in abrax­ane, Bris­tol My­ers Squibb says.

The an­nounce­ment comes on the heels of the FDA shoot­ing down a pe­ti­tion to stall gener­ic ver­sion of the drug. Five years af­ter the pe­ti­tion was filed, the FDA re­ject­ed it com­plete­ly in Ju­ly. The chemother­a­py drug brought in more than $1.2 bil­lion for Bris­tol My­ers in 2020.

The short­age af­fects 100 mg vials of the in­tra­venous lyophilized pow­der.

Stephen Liu, a tho­racic med­ical on­col­o­gist and as­so­ciate pro­fes­sor at George­town Uni­ver­si­ty, tweet­ed the an­nounce­ment last week, won­der­ing aloud if drug short­ages are im­pend­ing af­ter sup­ply chain is­sues.

Sar­to­rius blows out ex­pan­sion plans in Michi­gan

Ger­man man­u­fac­tur­er Sar­to­rius has an­nounced an ex­pan­sion in Michi­gan with the ad­di­tion of a 130,000-square-foot plant in the Ann Ar­bor Re­search Park.

The project is set to go on­line by 2023 and is ex­pect­ed to cre­ate 150 jobs over the next three years. Sar­to­rius has 22 sites across the world. The Michi­gan lo­ca­tion will en­able the com­pa­ny to scale up, and by 2025 the plan is to more than dou­ble its pro­duc­tion ca­pac­i­ty.

Sar­to­rius Ste­d­im Biotech ac­quired a ma­jor­i­ty stake in Ger­many-based Cell­Genix GmbH, the com­pa­nies an­nounced in June.. Sar­to­rius has ac­quired 51% of the com­pa­ny for $118.3 mil­lion and an­nounced the plan to ac­quire the re­main­ing shares of the com­pa­ny at the be­gin­ning of 2023 and 2026. The com­pa­ny will ex­pand the Freiburg site and es­tab­lish it as a man­u­fac­tur­er of raw ma­te­ri­als for cell and gene ther­a­py.

In­sulin fa­cil­i­ty in Malaysia hand­ed Form 483

A Malaysian sub­sidiary of Bio­con has land­ed in more hot wa­ter with the FDA af­ter an­oth­er Form 483 has flagged six more ob­ser­va­tions con­nect­ed to drug sub­stance, drug prod­uct and the de­vices fa­cil­i­ties.

The prob­lems stem from a Sep­tem­ber in­spec­tion. The site man­u­fac­tures in­sulin as­part in­jec­tion.

“We are con­fi­dent of ad­dress­ing these ob­ser­va­tions through pro­ce­dur­al en­hance­ments and an ap­pro­pri­ate Cor­rec­tive and Pre­ven­tive Ac­tion Plan, which will be sub­mit­ted to the US FDA in the stip­u­lat­ed time,” Bio­con said in a state­ment. “We do not ex­pect the out­come of this in­spec­tion to im­pact our com­mer­cial­iza­tion plans for in­sulin As­part in the US. Bio­con Bi­o­log­ics re­mains com­mit­ted to glob­al stan­dards of Qual­i­ty and Com­pli­ance.”

Al­mac ex­pands foot­print in Ire­land

North­ern Ire­land is get­ting a new man­u­fac­tur­ing site that will bring an­oth­er 60 jobs to the re­gion.

Labs, stor­age spaces, and of­fices are all a part of the planned ex­pan­sion, and the plan in­cludes changes to ac­cess roads, park­ing lots and paths. Pro­pos­als have been sub­mit­ted to Ar­magh City, Ban­bridge and Craigavon Bor­ough Coun­cil for con­sid­er­a­tion, ac­cord­ing to re­ports from Ar­magh I.

The new site will add an­oth­er 42,000 square feet to the com­pa­ny’s foot­print.

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.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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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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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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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.”