Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mount­ing its coun­ter­feit drug law­suit, nam­ing two “king­pins” and a com­plex net­work of con­spir­a­tors who al­leged­ly sold im­i­ta­tion bot­tles of its HIV meds, some of which end­ed up in US phar­ma­cies.

The phar­ma gi­ant on Wednes­day pro­vid­ed an up­date on what it called a “large-scale, so­phis­ti­cat­ed coun­ter­feit­ing con­spir­a­cy,” ac­cus­ing two new de­fen­dants of “lead­ing and or­ches­trat­ing” a scheme to sell hun­dreds of mil­lions of dol­lars in il­le­git­i­mate drugs pos­ing as meds such as Bik­tarvy and De­scovy.

Two Flori­da men, Lazaro Rober­to Her­nan­dez and Ar­man­do Her­rera, were named as “king­pin de­fen­dants” in re­cent­ly un­sealed court doc­u­ments and ac­cused of set­ting up and con­trol­ling a se­ries of “fly-by-night” whole­salers to sell the coun­ter­feit meds.

Ann Don­nel­ly

Back in Au­gust, US Dis­trict Judge Ann Don­nel­ly froze the as­sets of more than 50 new­ly named de­fen­dants, ac­cord­ing to the un­sealed doc­u­ments, in­clud­ing Her­nan­dez and Her­rera.

Gilead first filed suit back in Ju­ly 2021, and ear­li­er this year al­leged that de­fen­dants have sold more than 85,000 bot­tles of coun­ter­feit Gilead meds. The de­fen­dants al­leged­ly sold au­then­tic-look­ing bot­tles, pur­chased il­le­gal­ly from pa­tients, with coun­ter­feit doc­u­men­ta­tion, ac­cord­ing to a new com­plaint. In some cas­es, those bot­tles con­tained com­plete­ly dif­fer­ent drugs, ei­ther a gener­ic painkiller or high-dose tablets of the an­tipsy­chot­ic Sero­quel.

The an­tipsy­chot­ic can cause se­da­tion, drowsi­ness and oth­er se­ri­ous prob­lems when tak­en in com­bi­na­tion with oth­er drugs or at high dos­es. One pa­tient who un­know­ing­ly took the an­tipsy­chot­ic af­ter re­ceiv­ing a coun­ter­feit bot­tle of Bik­tarvy was un­able to speak or walk af­ter­ward, Gilead said in its first com­plaint.

While fed­er­al law re­quires pre­scrip­tion drugs to come with a pedi­gree, or a doc­u­ment track­ing every sale, de­fen­dants al­leged­ly dis­trib­uted bot­tles with fal­si­fied pedi­grees that claimed to trace the coun­ter­feits to an au­then­tic source.

“Gilead will con­tin­ue to work close­ly with the U.S. Food and Drug Ad­min­is­tra­tion (FDA), phar­ma­cies and the De­part­ment of Jus­tice to re­move coun­ter­feit and tam­pered med­ica­tion from cir­cu­la­tion and to pre­vent fu­ture dis­tri­b­u­tion of coun­ter­feit med­ica­tions,” the com­pa­ny said in a state­ment on Wednes­day.

Bik­tarvy was ap­proved for the treat­ment of HIV back in 2018, and Gilead spent a pri­or­i­ty re­view vouch­er a year lat­er to get De­scovy on the mar­ket for both treat­ment and pre­ven­tion. The drugs earned Gilead $2 bil­lion and $397 mil­lion in the US last quar­ter, re­spec­tive­ly.

“In­di­vid­u­als who be­lieve they have been dis­pensed a coun­ter­feit Gilead med­ica­tion should im­me­di­ate­ly re­port the med­i­cine to their health­care provider, phar­ma­cy and Gilead Prod­uct Qual­i­ty Com­plaints,” Gilead said Wednes­day.

Au­then­tic Bik­tarvy tablets are pur­plish-brown and cap­sule-shaped with the num­bers “9883” writ­ten on one side and “GSI” on the oth­er, ac­cord­ing to Gilead. De­scovy tablets are blue and rec­tan­gu­lar with “225” on one side and “GSI” on the oth­er.

Gilead has is­sued a list of trust­ed dis­trib­u­tors, in­clud­ing the big firms Car­di­nal Health, Amerisource­Ber­gen and McKesson.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

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FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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