Chris Collins speaks to reporters as he leaves the courthouse after a pretrial hearing in his insider-trading case, Thursday, Sept. 12, 2019 (AP Photo/Seth Wenig)

Trump par­dons Chris Collins, for­mer con­gress­man im­pris­oned for biotech in­sid­er trad­ing scan­dal

Just two months in­to a 26-month prison sen­tence for in­sid­er trad­ing, for­mer con­gress­man Chris Collins has been par­doned.

Collins is one of 15 peo­ple Don­ald Trump has par­doned in one of his last ex­er­cis­es of pres­i­den­tial pow­er. A House rep­re­sen­ta­tive of 7 years and the first sit­ting fed­er­al politi­cian to en­dorse Trump’s bid for pres­i­dent back in 2016, he was grant­ed a full par­don “at the re­quest of many Mem­bers of Con­gress,” ac­cord­ing to the White House.

The scan­dal that led to his res­ig­na­tion and land­ed him in prison re­volved around an Aus­tralian biotech named In­nate Im­munother­a­peu­tics, which had a lead drug for mul­ti­ple scle­ro­sis. Not on­ly did Collins’ fam­i­ly be­come the sec­ond largest share­hold­er and a board mem­ber, he was al­so an avid pro­mot­er of its stock, draw­ing in­vest­ments from neigh­bors, friends as well as fel­low mem­bers of Con­gress.

While his overzeal­ous pros­e­lytism prompt­ed a House ethics in­ves­ti­ga­tion in May 2017, he was ul­ti­mate­ly charged for pass­ing on the in­sid­er in­for­ma­tion — re­layed by the In­nate CEO to the board in June — that the com­pa­ny’s lead drug had failed a key tri­al.

At an am­ply pho­tographed pic­nic event on the White House lawn, Collins called his son, Cameron Collins, to tip him off so that he could sell his shares be­fore the in­evitable stock im­plo­sion once the pub­lic finds out.

It helped the younger Collins avoid $570,900 in loss­es. He al­so told his fa­ther-in-law and six oth­er stock­hold­er friends to sell, re­tain­ing around hun­dreds of thou­sands of dol­lars in to­tal.

When ques­tioned by the FBI, the con­gress­man lat­er ad­mit­ted, he lied.

“You had a du­ty to meet and you be­trayed that du­ty,” US Judge Ver­non Brod­er­ick of the South­ern Dis­trict of New York said to Collins at sen­tenc­ing.

Brod­er­ick lat­er de­cid­ed that his son de­served a more le­nient sen­tence, which amount­ed to five years pro­ba­tion in­clud­ing six months home con­fine­ment and 500 hours of com­mu­ni­ty ser­vice and a $150,000 fine.

Trump, though, chose to note high­light Collins’ “ear­ly ca­reer as a suc­cess­ful busi­ness­man and en­tre­pre­neur” and pub­lic ser­vice in a state­ment of clemen­cy:

Dur­ing his tenure in Con­gress, Mr. Collins was known for his par­tic­u­lar fo­cus on the well­be­ing of small busi­ness­es, agri­cul­ture, and sci­ences.

Collins could be re­leased in time for Christ­mas, two lawyers told Buf­fa­lo News.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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