Af­ter in­sid­er trad­ing scan­dal, US con­gress­man drops cam­paign — but stays on the bal­lot; Jun­shi Bio­sciences ap­plies for Hong Kong IPO

→ The US con­gress­man who was charged with in­sid­er trad­ing on a biotech stock last week has sus­pend­ed his cam­paign for re-elec­tion. New York GOP Rep. Chris Collins, the first mem­ber of Con­gress to en­dorse Trump for pres­i­dent in 2016, said in a state­ment that quit­ting the cam­paign would best serve his cir­cle.

“Af­ter ex­ten­sive dis­cus­sions with my fam­i­ly and friends over the last few days, I have de­cid­ed that it is in the best in­ter­ests of the con­stituents of NY-27, the Re­pub­li­can Par­ty and Pres­i­dent Trump’s agen­da for me to sus­pend my cam­paign for re-elec­tion to Con­gress,” he said.

That state­ment comes just days af­ter Collins in­sist­ed he would re­main on the bal­lot run­ning for re-elec­tion this No­vem­ber, de­spite the charges. And that ac­tu­al­ly might be true. Al­though he’s sus­pend­ing his cam­paign, it turns out with­draw­ing from the bal­lot is a lengthy and com­pli­cat­ed process.

In case you missed it, fed­er­al pros­e­cu­tors charged Collins, his son, and an­oth­er man with 13 counts of se­cu­ri­ties fraud, wire fraud, and false state­ments stem­ming from an al­leged in­sid­er trad­ing scheme in­volv­ing an Aus­tralian biotech com­pa­ny called In­nate Im­munother­a­peu­tics. Ac­cord­ing to the in­dict­ment, Collins tipped off his son and oth­ers that In­nate had flopped a clin­i­cal tri­al be­fore the in­fo was made pub­lic. His son and oth­ers al­leged­ly sold shares im­me­di­ate­ly af­ter, sav­ing hun­dreds of thou­sands of dol­lars in loss­es.

Shang­hai Jun­shi Bio­sciences has ap­plied for an IPO in Hong Kong — the ninth since the city opened up late April to pre-rev­enue biotechs — in the same week as BeiGene ex­pe­ri­enced a shaky de­but fol­low­ing a his­toric $903 mil­lion raise. Jun­shi is one of the lead­ers in a grow­ing crowd of Chi­nese drug­mak­ers swamp­ing the coun­try with home-grown PD-1/L1 check­point in­hibitors, with an NDA pend­ing at Chi­na’s drug ad­min­is­tra­tion. Some of the pro­ceeds, though, will al­so go to­ward the PC­SK9 drug and Hu­mi­ra biosim­i­lar that it’s de­vel­op­ing, ac­cord­ing to its fil­ing.

→ Cum­ber­land Phar­ma­ceu­ti­cals, a Nashville, TN-based spe­cial­ty phar­ma, has re­cruit­ed for­mer Am­gen $AMGN staffer Adam Hae­ber­le to serve as the com­pa­ny’s new se­nior di­rec­tor of clin­i­cal and reg­u­la­to­ry af­fairs. In the role, Hae­ber­le will over­see Cum­ber­land’s prod­uct de­vel­op­ment team de­sign­ing and im­ple­ment­ing clin­i­cal tri­als. He joins Cum­ber­land from Am­gen, where he most re­cent­ly worked as di­rec­tor of clin­i­cal de­vel­op­ment.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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