CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-own­er of a Flori­da-based clin­i­cal re­search site plead­ed guilty to ly­ing to an FDA in­ves­ti­ga­tor dur­ing a 2017 in­spec­tion, re­veal­ing that she false­ly por­trayed part of a Glax­o­SmithK­line pe­di­atric asth­ma study as le­git­i­mate, when in fact she knew that cer­tain da­ta had been fal­si­fied, the De­part­ment of Jus­tice said Wednes­day.

Three oth­er em­ploy­ees — Yvelice Vil­la­man Ben­cosme, Lisett Raven­tos and May­tee Lle­do — pre­vi­ous­ly plead­ed guilty and were sen­tenced in con­nec­tion with fal­si­fy­ing da­ta as­so­ci­at­ed with the tri­al at the CRO Un­lim­it­ed Med­ical Re­search.

“Re­li­able clin­i­cal tri­al da­ta is a foun­da­tion for FDA drug ap­proval. Fal­si­fy­ing that da­ta leaves con­sumers at risk of tak­ing drugs that are nei­ther safe nor ef­fec­tive,” said as­sis­tant com­mis­sion­er Cather­ine Hermsen for FDA’s Of­fice of Crim­i­nal In­ves­ti­ga­tions.

The pur­port­ed mas­ter­mind of the scheme, Vil­la­man Ben­cosme, plead­ed guilty to con­spir­a­cy to com­mit wire fraud in Jan­u­ary and was sen­tenced to 63 months in prison and for­feit­ed $174,000.

Vil­la­man Ben­cosme pre­vi­ous­ly ad­mit­ted that she at­tempt­ed to de­fraud GSK by us­ing pa­tients’ per­son­al in­for­ma­tion from her pri­vate med­ical prac­tice to cre­ate false in­for­ma­tion to be en­tered in­to case his­to­ries.

The plea deal list­ed one ex­am­ple of a pa­tient known on­ly as D.H., who Vil­la­man Ben­cosme had said was “do­ing well” and rec­om­mend­ed the con­tin­ued use of med­ica­tion af­ter a vis­it in April 2015. None of the physi­cian’s record­ed state­ments in the check­up were true, how­ev­er, as D.H. was not par­tic­i­pat­ing in the study.

Vil­la­man Ben­cosme fal­si­fied case his­to­ries for at least 11 in­di­vid­u­als and ad­mit­ted to par­tic­i­pat­ing in the scheme be­tween around Sep­tem­ber 2013 and June 2016.

The clin­i­cal tri­al in ques­tion was the GSK-spon­sored study dubbed VESTRI, ac­cord­ing to court doc­u­ments from last Au­gust. Re­searchers had aimed to mea­sure the long-term safe­ty of Ad­vair Diskus, an in­haled asth­ma med­ica­tion, in pa­tients aged 4 to 11 years old. Re­sults from the study were re­port­ed in March 2016 and pub­lished in the New Eng­land Jour­nal of Med­i­cine that Sep­tem­ber.

“As soon as we be­came aware of pos­si­ble clin­i­cal tri­al fraud we con­duct­ed an in­ter­nal in­ves­ti­ga­tion; ex­clud­ed the da­ta from the stud­ies and re­ports; and re­port­ed the po­ten­tial fraud to the FDA and the In­sti­tu­tion­al Re­view Boards,” GSK pre­vi­ous­ly said in a state­ment.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.