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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.