The 'mind-blow­ing' R&D re­nais­sance in psy­che­del­ic meds finds a home at Johns Hop­kins

The “mind-blow­ing” field of psy­che­del­ic re­search is get­ting its first ma­jor US home, one that could help le­git­imize a field that has slow­ly crept out of the shad­ows over the last two decades.

Johns Hop­kins Med­i­cine an­nounced Wednes­day they are open­ing what they be­lieve to be the first cen­ter for psy­che­del­ic re­search in the coun­try and the largest in the world.

The Cen­ter for Psy­che­del­ic and Con­scious­ness Re­search at Johns Hop­kins Med­i­cine will in­clude a team of 11 fac­ul­ty sci­en­tists and post-docs in­ves­ti­gat­ing the po­ten­tial use of LSD and psilo­cy­bin (the chem­i­cal found in mag­ic mush­rooms) — among oth­er psy­che­delics — to im­pact hu­man cre­ativ­i­ty and well-be­ing and to treat a host of dis­or­ders, in­clud­ing opi­oid ad­dic­tion, Alzheimer’s dis­ease and PTSD.

Once stud­ied ex­ten­sive­ly by the fed­er­al gov­ern­ment, psy­che­delics vir­tu­al­ly dis­ap­peared from re­search lab­o­ra­to­ries af­ter most were sched­uled as Class I drugs by the Nixon Ad­min­is­tra­tion in 1970. But since 2000, when Johns Hop­kins ob­tained ap­proval to ad­min­is­ter psy­che­delics to hu­man sub­jects who had nev­er tak­en one be­fore, sci­en­tists at a hand­ful of in­sti­tu­tions have steadi­ly brought the cat­e­go­ry of drugs in­to the sci­en­tif­ic fore­ground.

These re­searchers have de­scribed some of their re­sults as “mind-blow­ing” in their abil­i­ty to help pa­tients, as health writer Michael Pol­lan re­port­ed in the New York­er in 2015. Pol­lan has been one of the most promi­nent pro­mot­ers of psy­che­delics, writ­ing in pop­u­lar pub­li­ca­tions and his new book How to Change Your Mind about the po­ten­tial for this class of drugs to treat anx­i­ety and de­pres­sion with hereto­fore un­heard-of suc­cess.

In March, the FDA ap­proved a psy­che­del­ic drug for the first time: Es­ke­t­a­mine for treat­ing de­pres­sion. MD­MA (com­mon­ly called ec­sta­sy) re­ceived break­through ther­a­py sta­tus in 2017 and Phase III tri­als to use it as PTSD treat­ment have shown promise. Tri­als com­plet­ed at NYU and Hop­kins – which prompt­ed the “mind-blow­ing” de­scrip­tion – high­light­ed the po­ten­tial for the drugs to de­crease “ex­is­ten­tial dis­tress” in can­cer pa­tients.

Nev­er­the­less, sig­nif­i­cant le­gal hur­dles ex­ist to ob­tain­ing gov­ern­ment funds for psy­che­del­ic re­search and the cen­ter will be en­tire­ly pri­vate­ly fund­ed. The list of donors, though, re­flects the rep­u­ta­tion and cache the drugs have amassed among a younger gen­er­a­tion of in­flu­encers and Sil­i­con Val­ley types, who have dri­ven some of the de­vel­op­ment to date. They in­clude au­thor, tech in­vestor, and pod­cast host Tim Fer­riss, Word­Press co-founder Matt Mul­len­weg and TOMS founder Blake My­coskie.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.