Why would Co­hen reach out to No­var­tis, but not Roche?; WuXi Bi­o­log­ics blue­prints big R&D/man­u­fac­tur­ing com­plex

→ So why would Trump at­tor­ney Michael Co­hen reach out to sell his ser­vices to No­var­tis, but ig­nore the big Basel ri­val Roche? “I have asked in­ter­nal­ly if we had any con­tact, and that is not the case,” Sev­erin Schwan told Reuters.

→ A boom­ing WuXi Bi­o­log­ics is build­ing a new com­plex in Shi­ji­azhuang, Chi­na that will ex­pand its op­er­a­tions in re­search, de­vel­op­ment and man­u­fac­tur­ing. Its new man­u­fac­tur­ing ops will be built to glob­al cGMP stan­dards. “We are very pleased to es­tab­lish the largest bi­o­log­ics cen­ter in north­ern Chi­na, which will en­able lo­cal com­pa­nies to more ef­fec­tive­ly de­vel­op and man­u­fac­ture bi­o­log­ics and in the mean­time pro­vide a ro­bust sup­ply chain net­work for our glob­al clients. This ex­pan­sion will al­low us great ac­cess to lo­cal tal­ents, mar­kets and gov­ern­ment sup­port,” said Chris Chen, the CEO of WuXi Bi­o­log­ics.

→ Fol­low­ing a makeover af­ter a ma­jor clin­i­cal flop, Cam­bridge, MA-based Eleven Bio­ther­a­peu­tics is chang­ing its name and stock sym­bol. The com­pa­ny now goes by Sesen Bio, con­vert­ing its tick­er from $EBIO to $SESN. The brand­ing change makes sense, con­sid­er­ing Eleven was lit­tle more than a shell with a bank ac­count a cou­ple years ago af­ter its lead drug failed twice and it com­plet­ed a deal to li­cense out its re­main­ing pro­gram to Roche. But then the en­ti­ty ac­quired Toron­to-based Viven­tia Bio, snag­ging its now lead drug can­di­date vicini­um, a next-gen an­ti­body-drug con­ju­gate to treat high-grade non-mus­cle in­va­sive blad­der can­cer. “Over the last sev­er­al years, we have un­der­gone an in­cred­i­ble trans­for­ma­tion as a com­pa­ny, and our new name, Sesen Bio, re­in­forces this evo­lu­tion and our fo­cused com­mit­ment to on­col­o­gy drug de­vel­op­ment,” said Stephen Hurly, Sesen’s pres­i­dent and CEO, in a state­ment. “Sesen, an an­cient sym­bol of the lo­tus flower, rep­re­sents life and our mis­sion to bring for­ward med­i­cines that will im­prove and pre­serve the lives of those with dev­as­tat­ing can­cers.”

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat a stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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