Come join me dur­ing my round-the-world biotech ad­ven­ture in Oc­to­ber, with events in Lon­don and Shang­hai — plus

A few years ago I had a chance to do a half-day event in Lon­don with a top group of biotech ex­ecs, and I’ve been mean­ing to get back to the Gold­en Tri­an­gle for a re­turn event ever since.

Now, with the Great Around the Biotech World Trip I’m plan­ning for Oc­to­ber, that time has ar­rived.

On Oc­to­ber 10, I’m bring­ing to­geth­er a great group of lead­ers in the biotech com­mu­ni­ty for the first an­nu­al End­points News UK Bio­phar­ma Re­search & De­vel­op­ment Sum­mit, host­ed at the Sil­i­con Val­ley Bank au­di­to­ri­um in Lon­don. 

We’ll be cov­er­ing key is­sues like fi­nanc­ing trends, the ROI of drug de­vel­op­ment and new in­no­va­tion, and how top can­cer drug de­vel­op­ers in the coun­try are nav­i­gat­ing the huge burst of new stud­ies that has swelled the pipeline in re­cent years.

Mene Pan­ga­los

My pan­elists in­clude Mene Pan­ga­los, the EVP of In­no­v­a­tive Med­i­cines, at As­traZeneca; Tim Haines

Kate Bing­ham

from Abing­worth; Kate Bing­ham at SV Health In­vestors; John Pot­tage, CSO at Vi­iV; Nooman Haque at SVB; David Grainger at Medicxi; Jack­ie Hunter from Benev­o­len­tAI; Mike Rea from IDEA; Mal­colm Weir, CEO at Hep­tares; Niall Mar­tin, CEO from Ar­tios and David Chiswell, the leg­endary CAT co-founder who now helms Kymab.

Plus a few we have yet to name.

You can read all about the half-day agen­da here. If you want­ed me to sum up the ob­jec­tive here, I’d say I’m look­ing for a clear up­date on the Gold­en Tri­an­gle’s place in this fast-chang­ing biotech world, with in­vestors act­ing more bull­ish­ly than I’ve ever seen. And I’d like to show the bio­phar­ma world what it looks like from the per­spec­tive of some of the bright­est peo­ple in the field.

We have a lim­it­ed num­ber of seats avail­able for an event that will be record­ed for a lat­er broad­cast. And I’m look­ing for an au­di­ence as great as the pan­elists who are ap­pear­ing to dis­cuss cur­rent biotech events at the sum­mit. Bio­phar­ma ex­ecs look­ing to get in­to the con­ver­sa­tion are hearti­ly wel­come. Plus, we have a beer and wine mix­er at the end, which should be fun.

It’s a good thing that we are near­ly squared away on Lon­don, be­cause af­ter a quick trip to Mu­nich for ES­MO, I’ll be head­ed out to Shang­hai for a 2-day event we’re man­ag­ing with our part­ners in Chi­na, Pharm­Cube: US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit. We’re still bring­ing to­geth­er the pan­els for this, but we have head­line events planned with en­tre­pre­neur Saman­tha Du, CEO of Zai Labs, Vivek Ra­maswamy from Roivant, John Oyler, the CEO at BeiGene, Jonathan Wang from Or­biMed Asia and Fa­heem Has­nain, co-founder and ex­ec­u­tive chair­man of Gos­samer, who you may re­call arranged the $7.2 bil­lion sale of Re­cep­tos to Cel­gene and re­cent­ly raised $330 mil­lion for his new ven­ture. 

Plus, we have lots and lots more ex­ecs who will be join­ing us.

We’re go­ing to be talk­ing deals, dol­lars and ren­min­bi at a cru­cial in­ter­sec­tion for US, Chi­nese and Eu­ro­pean play­ers. So why are we ask­ing you to join us? By in­ter­min­gling key play­ers on both sides of the Pa­cif­ic — as well as from Eu­rope — we’d like to spark some new talks on col­lab­o­ra­tions, de­vel­op­ment deals and fi­nanc­ing op­por­tu­ni­ties. Chi­na’s fast-grow­ing in­dus­try is chang­ing every­thing about the glob­al in­dus­try, and this is the time to ful­ly ex­plore it and make some con­nec­tions.

Fi­nal­ly, I’ll be head­ed down to Aus­tralia to keynote the an­nu­al Aus­Biotech gath­er­ing, which I’m re­al­ly look­ing for­ward to. And then I plan to sleep on the en­tire trip back to Ver­mont.

You may have no­ticed that our mot­to here is End­points News: The bio­phar­ma world is here. We weren’t kid­ding around.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.