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US and Chi­na de­vel­op frame­work for in­spec­tion of 200 US-list­ed com­pa­nies un­der threat of delist­ing

The Pub­lic Com­pa­ny Ac­count­ing Over­sight Board (PCAOB) has struck an agree­ment with Chi­nese reg­u­la­to­ry au­thor­i­ties that would al­low the in­spec­tion of au­dit re­ports for US-list­ed Chi­nese com­pa­nies. Now, ac­cord­ing to SEC chair Gary Gensler, “The proof will be in the pud­ding.”

Rough­ly 200 Chi­nese com­pa­nies — in­clud­ing bio­phar­ma com­pa­nies BeiGene, Hutchmed, Zai Lab, I-Mab, Sino­vac, Gra­cell Biotech­nolo­gies, Ada­gene and Burn­ing Rock Biotech — have been sin­gled out by the SEC for vi­o­lat­ing a new law gov­ern­ing US-list­ed com­pa­nies. The law, called the Hold­ing For­eign Com­pa­nies Ac­count­able Act, stip­u­lates that any for­eign com­pa­nies au­dit­ed by a firm that the non­prof­it PCAOB is un­able to re­view for three con­sec­u­tive years should be delist­ed.

Gary Gensler

Cur­rent Chi­nese laws pre­vent au­di­tors from hand­ing over those records. But on Fri­day, Gensler an­nounced “the first time we have re­ceived such de­tailed and spe­cif­ic com­mit­ments from Chi­na” to al­low PCAOB in­spec­tions.

While keep­ing short on the de­tails, Gensler said the com­pa­nies have agreed that PCAOB in­spec­tors can se­lect any is­suer au­dits for in­spec­tion; get di­rect ac­cess to in­ter­view or re­ceive tes­ti­mo­ny from au­dit firm staffers; trans­fer in­for­ma­tion to the SEC; and see com­plete au­dit re­ports with­out any redac­tions.

“On this last item, the PCAOB was able to es­tab­lish view on­ly pro­ce­dures — as it has done in the past with cer­tain oth­er ju­ris­dic­tions — for tar­get­ed pieces of in­for­ma­tion (for ex­am­ple, per­son­al­ly iden­ti­fi­able in­for­ma­tion),” Gensler said in a news re­lease.

The news comes a day af­ter un­named sources told the Wall Street Jour­nal that the US and Chi­na are work­ing out a deal to al­low Amer­i­can reg­u­la­tors to re­view au­dit re­ports in Hong Kong.

The Chi­na Se­cu­ri­ties Reg­u­la­to­ry Com­mis­sion (CSRC) tout­ed the frame­work in a state­ment is­sued on Thurs­day, call­ing it an “im­por­tant first step by both sides” to re­solve the is­sue.

“Keep­ing Chi­nese com­pa­nies list­ed on the U.S. mar­kets is an all-win arrange­ment that ben­e­fits in­vestors, is­suers and both coun­tries in gen­er­al. This un­der­stand­ing forms com­mon ground for both sides to ne­go­ti­ate and reach the agree­ment,” the CSRC said.

Gensler em­pha­sized that the deal “will be mean­ing­ful on­ly if the PCAOB ac­tu­al­ly can in­spect and in­ves­ti­gate com­plete­ly au­dit firms in Chi­na.” In­spec­tors will need to be on the ground by mid-Sep­tem­ber in or­der to com­plete their re­views by the end of the year.

“When for­eign is­suers seek ac­cess to U.S. cap­i­tal mar­kets, they must abide by the same rules re­gard­ing au­dit­ing as our do­mes­tic is­suers,” he said. “While im­por­tant, this frame­work is mere­ly a step in the process.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

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Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

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As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

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Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.