Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA/Sipa via AP Images)

Con­gress takes an­oth­er look at re­clas­si­fy­ing psilo­cy­bin and MD­MA

Months af­ter Sens. Cory Book­er (D-NJ) and Rand Paul (R-KY) in­tro­duced a bill that would ex­pand ac­cess to Sched­ule I drugs for ter­mi­nal­ly ill pa­tients, the law­mak­ers are tak­ing an­oth­er stab.

Book­er and Paul on Thurs­day in­tro­duced a new bill called the Break­through Ther­a­pies Act, which would al­low the Drug En­force­ment Ad­min­is­tra­tion to make the nec­es­sary find­ings to re­clas­si­fy break­through ther­a­pies such as MD­MA or psilo­cy­bin as Sched­ule II drugs.

The Con­trolled Sub­stances Act was en­act­ed in 1970, and sep­a­rates sub­stances in­to five sched­ules, with Sched­ule I be­ing the most se­ri­ous. MD­MA and psilo­cy­bin are cur­rent­ly Sched­ule I sub­stances, mean­ing they have “no cur­rent­ly ac­cept­ed med­ical use and a high po­ten­tial for abuse” ac­cord­ing to the CSA’s lan­guage. Sched­ule II drugs are still char­ac­ter­ized as hav­ing a high risk of abuse, though they in­clude med­i­cines such as Oxy­Con­tin and Di­lau­did.

Re­clas­si­fy­ing cer­tain ther­a­pies that con­tain Sched­ule I sub­stances would “help fa­cil­i­tate a phased roll-out of these po­ten­tial­ly life­sav­ing ther­a­pies via FDA-ap­proved Ex­pand­ed Ac­cess pi­lot pro­grams,” the sen­a­tors said, and “re­move bur­den­some fed­er­al reg­u­la­tions that im­pede re­search and de­vel­op­ment.”

The new bill dif­fers from their pre­vi­ous­ly in­tro­duced Right to Try Clar­i­fi­ca­tion Act, which would skirt around the FDA’s ex­pand­ed ac­cess pro­gram and the DEA’s reg­u­la­tions around con­trolled sub­stances, and al­low pa­tients to po­ten­tial­ly ac­cess Sched­ule I drugs more eas­i­ly.

“Re­cent stud­ies sug­gest that some Sched­ule I sub­stances such as MD­MA and psilo­cy­bin could rep­re­sent an enor­mous ad­vance­ment for the treat­ment of se­vere post-trau­mat­ic stress dis­or­der, de­pres­sion and ad­dic­tion,” Book­er said in a news re­lease on Thurs­day. “Un­for­tu­nate­ly, reg­u­la­to­ry red tape and a se­ries of bu­reau­crat­ic hur­dles in­volved in study­ing Sched­ule I sub­stances im­pedes crit­i­cal re­search on these and oth­er promis­ing Sched­ule I com­pounds.”

Psilo­cy­bin, an ac­tive sub­stance in “mag­ic mush­rooms,” is cur­rent­ly un­der de­vel­op­ment by a va­ri­ety of com­pa­nies for con­di­tions such as PTSD and treat­ment-re­sis­tant de­pres­sion. Sim­i­lar­ly, MD­MA has been stud­ied in PTSD and anx­i­ety in ter­mi­nal­ly ill pa­tients.

Book­er and Paul aren’t the first to sug­gest that cer­tain ther­a­pies con­tain­ing Sched­ule I sub­stances should be re­clas­si­fied. Just last month, Seat­tle doc­tor Sunil Ag­gar­w­al took his fight to change psilo­cy­bin’s CSA sta­tus to fed­er­al court. While Ag­gar­w­al had asked the DEA in Feb­ru­ary to re­clas­si­fy psilo­cy­bin as a Sched­ule II sub­stance, the agency re­spond­ed that the FDA “has not ar­tic­u­lat­ed any ac­cept­ed med­ical use” for the drug. On Oct. 20, he pe­ti­tioned the Ninth Cir­cuit Court of Ap­peals to re­view the DEA’s de­ci­sion.

Robert Bar­row

Robert Bar­row, whose com­pa­ny MindMed is de­vel­op­ing a range of ther­a­pies based on psy­che­delics such as LSD and MD­MA, told End­points News on Fri­day that “see­ing a step in the right di­rec­tion in terms of en­abling more stream­lined re­search is re­al­ly ex­cit­ing.” The com­pa­ny is al­so sup­port­ing in­ves­ti­ga­tor-ini­ti­at­ed psilo­cy­bin stud­ies at the Uni­ver­si­ty Hos­pi­tal of Basel in Switzer­land.

“One thing I would want to think about more ful­ly and want to di­gest ful­ly is the ex­act im­pli­ca­tion that it does put a high de­gree of fo­cus on the des­ig­na­tion of a prod­uct as a break­through ther­a­py,” he added. “We see op­por­tu­ni­ties be­yond just break­through ther­a­py-des­ig­nat­ed prod­ucts that could ben­e­fit from stream­lined reg­u­la­to­ry func­tion here in the US.”

A cor­rec­tion has been made to clar­i­fy that MindMed does not have an in-house psilo­cy­bin pro­gram, but is sup­port­ing psilo­cy­bin re­search through a col­lab­o­ra­tion with the Uni­ver­si­ty Hos­pi­tal of Basel in Switzer­land.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.