A Flori­da man who fal­si­fied med­ical records in con­nec­tion to clin­i­cal tri­als was sen­tenced to 30 months in prison in fed­er­al court Thurs­day.

Daniel Teje­da, 35, of Clewis­ton, was al­so or­dered to pay $2.1 mil­lion in resti­tu­tion. Teje­da was a project man­ag­er and study man­ag­er for the CRO Tel­lus Clin­i­cal Re­search, and made it ap­pear that sub­jects were par­tic­i­pat­ing in tri­als when they weren’t. Two oth­er re­search work­ers from Flori­da were sen­tenced in the same case in Au­gust for 46 and 30 months, re­spec­tive­ly.

Teje­da was sen­tenced by fed­er­al judge Robert Sco­la of the South­ern Dis­trict of Flori­da.

The tri­als were to eval­u­ate a drug for ir­ri­ta­ble bow­el syn­drome, opi­oid de­pen­den­cy and di­a­bet­ic nephropa­thy. In the past, Tel­lus has worked with gi­ants such as Pfiz­er, Gilead and Take­da. Work on some of those tri­als came in­to ques­tion in the past, in­clud­ing tri­als on opi­oid de­pen­den­cy — spon­sored by Brae­burn Phar­ma­ceu­ti­cals — and di­a­betes, run by Gilead. Last March, four more em­ploy­ees, in­clud­ing the own­er, were charged with con­spir­a­cy to com­mit mail and wire fraud and mon­ey laun­der­ing charges.

“Clin­i­cal tri­als help en­sure that new drugs are safe and ef­fec­tive for the pub­lic,” act­ing as­sis­tant at­tor­ney gen­er­al Bri­an Boyn­ton said in a state­ment. “Fal­si­fy­ing clin­i­cal tri­al da­ta un­der­mines a crit­i­cal com­po­nent of the drug ap­proval process. The De­part­ment of Jus­tice will con­tin­ue to work with our part­ners at the FDA to in­ves­ti­gate and pros­e­cute any­one who puts per­son­al prof­it over pub­lic health by fal­si­fy­ing clin­i­cal tri­al da­ta.”

The tri­als in ques­tion were be­tween Feb­ru­ary 2014 to Ju­ly 2016. The em­ploy­ees charged know­ing­ly en­rolled can­di­dates who did not meet the el­i­gi­bil­i­ty cri­te­ria, fal­si­fied lab re­sults, fal­si­fied med­ical records and said that the pa­tients were tak­ing the drugs when they weren’t.

The sen­tence is much more for­giv­ing than the max­i­mum penal­ty of 20 years in prison.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.