'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.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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2019 a 'trans­for­ma­tive year' for phar­ma M&A. Is that a good thing?

Big Pharma keeps getting bigger.

Fueled by the mega-mergers between Bristol-Myers Squibb and Celgene and between Allergan and AbbVie, the industry last year saw $350 billion worth of M&A, according to the new year-end report from the consultants at PwC.  That’s a more than 50% increase on 2018.

“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News. 

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UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.