BeiGene scram­bles to find new Abrax­ane sup­pli­er as Chi­nese in­spec­tors or­der halt on im­ports, cit­ing Bris­tol My­ers fail­ure

In a slap in the face aimed right at one of the world’s largest drug­mak­ers, BeiGene $BGNE said to­day that it is be­ing forced by Chi­nese of­fi­cials to halt im­ports of the can­cer drug Abrax­ane.

Ac­cord­ing to the Chi­na-based BeiGene, the Chi­na Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion — or NM­PA — or­dered the halt fol­low­ing an in­spec­tion of one of Bris­tol My­ers’ US fa­cil­i­ties used to make the drug. That’s a rare event in the glob­al drug mak­ing world, where the FDA is known for its reg­u­lar ci­ta­tions for over­seas drug man­u­fac­tur­ers.

BeiGene did not ex­plain what the Chi­nese of­fi­cials found in the in­spec­tion that caused the prob­lems for Abrax­ane. But the com­pa­ny said it’s scram­bling to find an­oth­er sup­pli­er for the drug, which it li­censed from Cel­gene, as they try to re­solve the is­sues raised by Chi­nese in­spec­tors.

Ac­cord­ing to a Bris­tol My­ers spokesman:

A re­cent in­spec­tion of the Chi­nese gov­ern­men­tal body at a third-par­ty man­u­fac­tur­ing site that pro­duces Abrax­ane for the Chi­na mar­ket iden­ti­fied op­por­tu­ni­ties for im­prove­ment. We are work­ing close­ly with the Chi­nese health au­thor­i­ties and the man­u­fac­tur­ing site to im­ple­ment cor­rec­tive ac­tions and pre­ven­tive mea­sures to ad­dress their find­ings. In par­al­lel, we are pur­su­ing li­cen­sure of an al­ter­nate man­u­fac­tur­ing site as part of the path for­ward in Chi­na.

An­a­lysts were quick to seize on this as a pos­si­ble is­sue for in­vestors who own some of Bris­tol My­ers’ $9 CVRs from the Cel­gene buy­out. The CVR is based on a sched­ule of FDA ap­provals on 3 drugs over the next year.

Re­la­tions be­tween Chi­na and the US have been fraught with ten­sion ever since Don­ald Trump be­came pres­i­dent and be­gan to pres­sure Chi­na to make some fun­da­men­tal changes in the way they han­dle ex­ports to the US. Re­cent­ly, that pres­sure has watched up dur­ing the pan­dem­ic. But Chi­na, which was hit first by the out­break, has been the first to de­clare vic­to­ry over the coro­n­avirus.

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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FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's OCE makes the case for ac­cel­er­at­ed ap­proval rid­er in user fee reau­tho­riza­tion

Four experts from the FDA’s Oncology Center of Excellence took to the New England Journal of Medicine yesterday to make the case for not only improving the agency’s ability to expeditiously pull dangling accelerated approvals when, on the rare occasion, confirmatory trials fail, but also better building “quality and efficiency into the AA on-ramp.”

The timely perspective arrives as Congress has exactly one week left to draft, release and sign off on the reauthorized user fee deals before layoff notices will be sent to drug reviewers. That package, which is likely to hitch a ride with the continuing resolution, may or may not include several policy riders (opposed by Republicans), including one that would allow the FDA to require confirmatory trials to be underway before an AA is granted, and would improve the process by which FDA can withdraw AAs.

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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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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