Wel­come to CPhI week: The drug man­u­fac­tur­ing in­dus­try's pre­mier con­fer­ence kicks off with the winds of change blow­ing

Wel­come to CPhI week!

Tues­day marked the open­ing of this year’s CPhI Glob­al con­fer­ence in Mi­lan, Italy, in what marks its re­turn to an on­site event for the first time since 2019.

In many ways, this year’s CPhI is dif­fer­ent for us here at End­points News. We aren’t on site — as we cer­tain­ly plan to be next year — so we can’t give you the in­side scoop you can ex­pect in the fu­ture. How­ev­er, our team has been close­ly fol­low­ing the biggest trends from the past year and are stay­ing abreast of what CPhI’s sta­ble of ex­perts are say­ing about the fu­ture of the in­dus­try.

First, man­ag­ing ed­i­tor Kyle Blanken­ship dives head­first in­to some of the biggest trends from the past 12 months in the man­u­fac­tur­ing in­dus­try — and a few things to ex­pect in the year ahead.

Then, in the first of a se­ries of trend pieces, man­u­fac­tur­ing re­porter Josh Sul­li­van looks at the growth of the CMO in­dus­try, which is poised to take its place among the big dogs in terms of man­u­fac­tur­ing ca­pac­i­ty in the com­ing years.

Josh then dives in­to the fu­ture of au­toma­tion in bio­phar­ma, the grow­ing role of con­tract man­u­fac­tur­ing in Chi­na, the sky-high con­fi­dence the in­dus­try has go­ing in­to 2022, and fi­nal­ly the lin­ger­ing ef­fects an in­spec­tion back­log could have on the in­dus­try writ large.

As al­ways, if you have any feed­back, we’d be hap­py to hear from you. En­joy CPhI, and if you’re in Mi­lan: Ciao!

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Rahul Singhvi, Resilience CEO

Q&A: Re­silience boss Rahul Singhvi talks $2B US bio­man­u­fac­tur­ing ini­tia­tive and post Se­ries D deals

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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