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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

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