What oth­er biotech news have you been miss­ing? A big Chi­na IPO and more

Af­ter the Hong Kong ex­change saw the first slate of biotech IPOs plunge well be­low their de­but price, the in­vest­ment crowd got more than a lit­tle wor­ried about what the fu­ture held for oth­er Chi­nese play­ers look­ing to raise cash. But Shang­hai Jun­shi Bio­sciences has helped ease the fret­ting — for now — af­ter watch­ing its stock leap on their roll­out Mon­day.

Ac­cord­ing to Reuters the com­pa­ny raised close to $400 mil­lion and then cheered on a 22% surge in their stock price. And that fol­lows a suc­cess­ful launch for In­novent, an­oth­er pre­mier Chi­na biotech, which has al­so seen a surge since their IPO some weeks ago.

As­cle­tis, the first to take the plunge, has seen 60% of its mar­ket cap dis­ap­pear af­ter the his­toric first step this year. And BeiGene has al­so ex­pe­ri­enced heavy tur­bu­lence.

Li­nus Yip, Chief Strate­gist at First Shang­hai Se­cu­ri­ties, told Reuters that a more re­al­is­tic val­u­a­tion helped set the stage for the lat­est IPO to suc­ceed.

His­to­gen­ics shares evis­cer­at­ed af­ter FDA frowns on PhI­II da­ta

His­to­gen­ics $HS­GX saw its share price get shred­ded af­ter re­port­ing their de­ci­sion to drop Neo­Cart af­ter the FDA de­mand­ed to see more da­ta on Neo­Cart be­fore they would ac­cept a BLA for re­view. The stock dropped 75% as the biotech added that it is bring­ing in con­sul­tants to re­view strate­gic op­tions — which in­cludes bank­rupt­cy pro­tec­tion. His­to­gen­ics shares are now deep in pen­ny stock ter­ri­to­ry.

Ab­b­Vie pays In­dia biotech $30M to part­ner on MALT1 for can­cer

Ab­b­Vie has turned to In­dia’s Lupin for an add-on ap­proach for its on­col­o­gy R&D group. 

Lupin says that the phar­ma gi­ant is pay­ing $30 mil­lion in cash up­front to part­ner on its MALT1 in­hibitors. The pro­tein is linked with T-cell and B-cell lym­pho­cyte ac­ti­va­tion, and Ab­b­Vie plans to test it for hema­to­log­i­cal can­cers.

If it works, there are $947 mil­lion in mile­stones to col­lect.

Mi­cro­bio­me start­up Vedan­ta scores $27M in Se­ries C 

Un­like ri­vals such as Seres and Re­bi­otix who are de­vel­op­ing pills in an ef­fort to treat dis­ease by har­ness­ing gut mi­crobes found in healthy fe­ces, Vedan­ta is de­vel­op­ing a con­sor­tium of bac­te­ria man­u­fac­tured from pure, clon­al cell banks that the biotech hopes can in­duce a range of im­mune re­spons­es.

The Cam­bridge, Mass­a­chu­setts-based com­pa­ny, which has al­ready joined forces with J&J’s $JNJ Janssen and Bris­tol-My­ers Squibb $BMY, on Mon­day said it had raised $27 mil­lion in a Se­ries C round from in­vestors in­clud­ing the Bill & Melin­da Gates Foun­da­tion, Bris­tol-My­ers, Rock Springs Cap­i­tal, In­vesco As­set Man­age­ment, Sev­en­ture Part­ners, and PureTech Health.

The mon­ey will be used to fi­nance the de­vel­op­ment of 4 of the com­pa­ny’s ex­per­i­men­tal drugs, in­clud­ing a Phase I/II study of VE416 in food al­ler­gy, a Phase Ib/II study of VE800 and Bris­tol-My­er’s Op­di­vo in ad­vanced or metasta­t­ic can­cers, and the re­cent­ly ini­ti­at­ed Phase II study of VE303 in re­cur­rent C. diff, which were cre­at­ed out of Vedan­ta’s clus­ter of bac­te­r­i­al strains.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better,

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Covid-19 roundup: CanSi­no beats Mod­er­na to pub­li­ca­tion of first-in-hu­man da­ta for a coro­n­avirus vac­cine

China’s CanSino Biologics has released results from the Phase I trial of its Covid-19 vaccine — data that have propelled its entry into Phase II more than a month ago.

In a paper published in the Lancet, the biotech reported that their adenovirus-based vaccine was “tolerable and immunogenic at 28 days post-vaccination” among the 195 volunteers enrolled in the trial. In addition to antibody responses, T cell responses were also observed.

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