Alex Zha­voronkov fol­lows land­mark AI pa­per with $37M round for In­sil­i­co fea­tur­ing top-notch Chi­na VCs

Nisa Leung

Days after Alex Zhavoronkov’s team demonstrated just how their generative machine learning model could be used to discover new compounds, Chinese investors are once again congregating at Insilico’s corner to offer a fresh round of cash to move that work forward.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Covid-19 and weak da­ta force pipeline re­vamp at Rea­ta, but the best tri­als go for­ward — with some cre­ative adap­tions

A confluence of weak clinical results and the rising tide of problems besetting clinical trials in the age of coronavirus has scuttled a significant part of the pipeline effort at Reata Pharmaceuticals.

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John Reed, Sanofi’s global head of R&D (Image: Endpoints News)

IL-6 to the res­cue? Sanofi, Re­gen­eron bar­rel ahead in­to an­oth­er piv­otal ef­fort test­ing Kevzara for Covid-19

Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and high dose of Kevzara against placebo, setting the stage for the Phase III followup.

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David Hal­lal bags an­oth­er whop­per round, look­ing to re­cruit more cell and gene ther­a­py up­starts to El­e­vate­Bio Base­Camp

Less than a year after attracting a launch round of $150 million, ex-Alexion chief David Hallal isn’t breaking stride — yet — for a pandemic. His startup cell and gene therapy player ElevateBio in Waltham, MA has attracted another whopper round, with ambitious plans to build up its portfolio of upstarts.

The latest round includes a bevy of new investors: The Invus Group, Surveyor Capital, EDBI, and Vertex Ventures — backed by Temasek. They’re signing up alongside existing investors, including F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, and Samsara BioCapital.

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New­ly-pub­lic Im­muno­vant an­nounces first proof-of-con­cept suc­cess

Immunovant announced its first batch of proof-of-concept data for its antibody against a rare autoimmune disease, a month after its biggest rival slid one of its dogs out of the race.

In a tiny study of thyroid eye disease, 4 out of 7 patients given IMVT-1401 saw their clinical activity score improve by 2 or more points and 3 out of 7 saw their proptosis — eye protrusion — improve. There was a 65% reduction in IgG, the protein IMVT-1401 is meant to block, which was “nearly identical to modeled predictions for dosing regimen” in the trial.

Lund­beck adds a Parkin­son's flop to its list of set­backs, writ­ing off a $1.1 bil­lion deal on mid-stage fail­ure

Anders Götzsche’s shot at R&D glory has ended in defeat at Lundbeck.

The Lundbeck CFO was acting chief when he struck a $1.1 billion deal to snare Prexton Therapeutics and its single asset — foliglurax — after Kåre Schultz jumped ship to run Teva. Götzsche agreed to pay €100m in cash and up to €805m in development and sales milestones to get the one-drug company.

It proved to be a bust in Phase IIa, though, with no significant difference in “off” times for patients or any separation from placebo for dyskinesia, a key secondary. Those “off” periods are marked by physical freezing or slowing of motor functions.