South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Sam­sung ex­ec­u­tives in Ko­rea are go­ing to jail.

The con­vic­tions came in what pros­e­cu­tors had billed as “biggest crime of ev­i­dence de­struc­tion in the his­to­ry of South Ko­rea”: a case of al­leged cor­po­rate in­trigue that was thrown open when in­ves­ti­ga­tors found what was hid­den be­neath the floor of a Sam­sung Bi­o­Log­ics plant. Eight em­ploy­ees in to­tal were found guilty of ev­i­dence tam­per­ing and the three ex­ec­u­tives were each sen­tenced to up to two years in prison.

The court did not rule on larg­er al­le­ga­tions of fraud that have swirled around the com­pa­ny. Lee Jae-yong, Sam­sung’s de fac­to leader, still faces bribery charges in a sep­a­rate case.

“De­stroy­ing and hid­ing ev­i­dence in a group-wide move re­gard­ing the ac­count­ing fraud case that was an is­sue the pub­lic took in­ter­est in is not a light crime,” the court said, per Yon­hap, a South Ko­re­an news agency. “The meth­ods for con­ceal­ment, which are dif­fi­cult for an av­er­age per­son to imag­ine, al­so shocked so­ci­ety.”

On a warm af­ter­noon in mid-May, South Ko­re­an in­ves­ti­ga­tors moved in on a Sam­sung Bi­o­Log­ics plant on the out­skirts of West­ern Seoul. Rip­ping open a meet­ing room floor, they found a trove of lap­tops, USB dri­ves and a com­put­er serv­er. It was not the first raid in a case that was opened last No­vem­ber and had its roots as far back as 2015.

That year, Ko­rea’s fi­nan­cial watch­dog com­plained that Sam­sung Bi­o­log­ics’ val­ue had been in­flat­ed by $3.8 bil­lion be­fore its 2016 pub­lic list­ing. Sam­sung re­vealed it was be­ing au­dit­ed in May of 2018 and pros­e­cu­tors picked it up the fol­low­ing No­vem­ber. Of­fi­cials sus­pect­ed the com­pa­ny of il­le­gal­ly chang­ing its ac­count­ing meth­ods in a move that in­flat­ed the val­ue of their stake in Sam­sung Bioepis, a joint ven­ture with Bio­gen.

Pros­e­cu­tors al­leged that four days af­ter Sam­sung Elec­tron­ics re­ceived no­tice of the probe in May 2018, they held an ur­gent meet­ing at the head of­fice, where they de­cid­ed to erase da­ta, ac­cord­ing to the Ko­re­an Bio­med­ical Re­view. They told Bi­o­Log­ics and Bioepis to do the same, pros­e­cu­tors al­leged, and then re­quest­ed to erase log records to delete ev­i­dence of the dele­tion.

Af­ter delet­ing the da­ta from the main serv­er, Sam­sung Bi­o­Log­ics took the pre­vi­ous servers and back­up servers that still held the da­ta and placed them be­neath the floor in one of the rooms.

“Ini­tial­ly, the pros­e­cu­tion was nev­er able to think that they would have torn the floor, and this floor could not be lift­ed by hand,” pros­e­cu­tors said, ac­cord­ing to KBR.

The em­ploy­ees lat­er ad­mit­ted to hav­ing delet­ed da­ta, but said their ac­tions were not linked to any al­leged fraud. Pros­e­cu­tors had sought sen­tences of up to 4 years.

Talk around the case has cen­tered in part on Lee Jae-yong, the el­dest child of Sam­sung chair­man and scion Lee Kun-hee. Crit­ics say he stood to ben­e­fit from the val­u­a­tion changes in 2015, and ex­perts told the Fi­nan­cial Times this week’s con­vic­tions could trig­ger fur­ther in­ves­ti­ga­tions in­to the em­bat­tled heir.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Franz-Werner Haas, CureVac CEO

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Martin Shkreli (Shutterstock)

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Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

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Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

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(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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