'Burn­er' phones and Ari­ad se­crets: Gold­man Sachs banker pleads guilty for his role in glob­al in­sid­er trad­ing ring

A for­mer Gold­man Sachs banker has plead­ed guilty to con­spir­ing to com­mit se­cu­ri­ties fraud as an­oth­er mem­ber of the glob­al biotech in­sid­er trad­er ring stands tri­al in Man­hat­tan.

Bryan Co­hen ad­mit­ted to steal­ing ma­te­r­i­al, non-pub­lic in­for­ma­tion from the in­vest­ment bank about cor­po­rate ac­qui­si­tions, some of them re­lat­ed to com­pa­nies list­ed on US ex­changes. But un­like Tele­maque Lavi­das, who al­leged­ly fed in­for­ma­tion about Ari­ad to New York busi­ness­man George Nikas, Co­hen turned his in­tel over to “a se­cu­ri­ties trad­er based in Switzer­land,” pro­vid­ing up­dates about how the deals were pro­gress­ing over time.

The in­sid­er in­for­ma­tion Co­hen pro­vid­ed al­lowed that trad­er to “place time­ly, prof­itable trades” and reap “sub­stan­tial prof­its,” ac­cord­ing to the su­per­sed­ing in­dict­ment and court state­ments quot­ed by the US At­tor­ney in the South­ern Dis­trict of New York.

“In ex­change for pro­vid­ing MN­PI he stole from In­vest­ment Bank A, CO­HEN re­ceived ben­e­fits, in­clud­ing cash, from the se­cu­ri­ties trad­er,” ac­cord­ing to a re­lease.

That Swiss trad­er Co­hen was in con­tact with could be Marc De­mane-De­bih, whom Bloomberg re­port­ed was ar­rest­ed last year in Ser­bia, ex­tra­dit­ed to the US, plead­ed guilty and is co­op­er­at­ing with pros­e­cu­tors.

De­mane-De­bih claimed that Nikas told him about in­side in­for­ma­tion on Ari­ad ob­tained from Lavi­das and his fa­ther, then a board mem­ber of the biotech. In turn, pros­e­cu­tors said, De­mane-De­bih al­so passed in­for­ma­tion to Nikas along­side two oth­er in­vest­ment bankers and one oth­er se­cu­ri­ties trad­er.

The loose­ly con­nect­ed group “took nu­mer­ous steps to con­ceal their un­law­ful scheme, in­clud­ing the use of mul­ti­ple un­reg­is­tered ‘burn­er’ cell­phones to com­mu­ni­cate with each oth­er,” the in­dict­ment for Lavi­das charged. In one in­stance, Co­hen al­leged­ly com­mu­ni­cat­ed with oth­er mem­bers of the scheme on his burn­er phone from a restau­rant owned and op­er­at­ed by Nikas.

Co­hen — who’s worked in both Lon­don and New York of­fices of Gold­man Sachs and has been on leave since his ar­rest in Oc­to­ber — has been fired, Bloomberg added.

The max­i­mum sen­tence to the one count he plead­ed guilty to is five years. His tri­al is sched­uled for Feb­ru­ary 4.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

Heron earns a sec­ond slap­down from the FDA on pain med — shares with­er

Intercept wasn’t the only biotech in line for a drubbing today. In addition to the rejection for NASH, Heron Therapeutics $HRTX put out word this morning that the FDA found its application for the pain drug HTX-011 was wanting, warranting another CRL.

Heron says there was nothing clinical about the slapdown, with no demands for new safety or efficacy data, or even a challenge on CMC — which was what they said was behind the first rejection that arrived for HTX-011 a little more than a year ago. Instead, the biotech reported that the agency had 4 basic concerns about the drug, designed to address post-operative pain.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.