Let's go to Chi­na: Join End­points in Shang­hai for the first US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit — Oc­to­ber 22-23 #BI­IS18

Re­cent­ly I told read­ers about a new part­ner­ship we struck in Chi­na, one that would help il­lu­mi­nate our on­line news cov­er­age of bio­phar­ma in an area of the world that has at­tract­ed a break­through lev­el of in­ter­est this year. Now we’re tak­ing it a step fur­ther, invit­ing End­points News read­ers to Chi­na for our in­au­gur­al 2-day in­dus­try con­fer­ence we’re host­ing in Shang­hai: BI­IS — US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit.

We’re host­ing this event be­cause it’s an ab­solute­ly crit­i­cal time for US com­pa­nies to de­vel­op their own Chi­na strat­e­gy, both for the re­gion­al deals they want as well as col­lab­o­ra­tions with a new gen­er­a­tion of Chi­nese re­searchers and ex­ec­u­tives.

Along with our part­ners in Chi­na, Pharm­Cube, we’ve in­vit­ed a group of transpa­cif­ic in­dus­try VIPs to head­line this two-day event, sched­uled for Oc­to­ber 22 and 23 at the Four Sea­sons in Shang­hai’s Pudong dis­trict.

Saman­tha Du

Just a few of the in­dus­try lead­ers we’ve con­firmed for the sum­mit are Saman­tha Du, the founder and CEO of Zai Lab; Jonathan Wang, co-founder of Or­biMed Asia; and Vivek Ra­maswamy, the founder and CEO of Roivant Sci­ences. New speak­ers are be­ing added fre­quent­ly, which you can check out on the event web­site here.

Vivek Ra­maswamy

Over the past year we’ve seen the Chi­na biotech scene boom with bil­lions of dol­lars in new in­vest­ment cash pour­ing in­to a host of star­tups. Most of these new-breed com­pa­nies are turn­ing first to fill­ing the tech gap that sep­a­rates Chi­na from the West, but you can al­ready see pipelines be­ing grown with new drugs that will be aimed at a world mar­ket.

Jonathan Wang

This two-day sched­ule will be packed with pan­els and pre­sen­ta­tions aimed at giv­ing you an in­side look at the key play­ers in Chi­na and the US, and the drugs that are now fill­ing the coun­try’s fast-grow­ing pipeline.

Like our pop­u­lar an­nu­al events at JP Mor­gan and BIO, and the up­com­ing UK R&D sum­mit in Lon­don, the Chi­na-US sum­mit will be helmed by End­points ed­i­tor and founder John Car­roll, who’s been study­ing the Chi­nese biotech mar­ket over the course of his 16 years of bio­phar­ma cov­er­age.

We’ve been chron­i­cling the reg­u­la­to­ry, fi­nan­cial, and sci­en­tif­ic trends that have led to this in­flec­tion point in Chi­na’s bio­phar­ma scene. And BI­IS is the event where you can wit­ness the dy­nam­ics and meet the peo­ple in­volved first­hand. We hope to see you there. Check out the event and reg­is­ter at this link: #BI­IS18 Event Site

— Ar­salan Arif is the founder and pub­lish­er of End­points News. You can reach him at aa@end­pointsnews.com or @AKAarsalan on Twit­ter.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.