Ayahuas­ca in­spires an­oth­er biotech start­up at ATAI; My­lan TB drug gets green light in In­dia

→ We have one more start­up to add to the list be­fore we call it a day. ATAI Life Sci­ences, which likes to dab­ble with psy­che­delics in de­vel­op­ing new ther­a­pies, has an­oth­er mind ben­der in the works. They’ve kick­start­ed a new com­pa­ny to delve in­to  for­mu­la­tions of N,N-di­methyl­trypt­a­mine (DMT) —the ac­tive in­gre­di­ent in ayahuas­ca — for new drugs to use in the men­tal health field. DMT acts as a par­tial ag­o­nist on a va­ri­ety of 5-HT re­cep­tors, they say, which makes it a good can­di­date for pa­tients not at­tract­ed to the po­tent brew fea­tured on cer­tain South Amer­i­can jour­neys. “These nov­el prod­ucts are ex­pect­ed to sim­pli­fy in-clin­ic ad­min­is­tra­tion and al­low greater phar­ma­co­ki­net­ic con­trol of the psy­che­del­ic ex­pe­ri­ence and its over­all du­ra­tion,” said Srini­vas Rao, chief sci­en­tif­ic of­fi­cer of ATAI. “Pa­tients may even be able to at­tend psy­chother­a­py ses­sions lat­er the same day.”

My­lan has re­ceived the green light from reg­u­la­tors in In­dia for its tu­ber­cu­lo­sis drug pre­tomanid. It’s on­ly the third treat­ment for drug-re­sis­tant forms of the dis­ease to be ap­proved in more than 40 years, fol­low­ing J&J’s be­daquiline and Ot­su­ka’s de­la­manid. In­dia ac­counts for rough­ly 25% of the world’s tu­ber­cu­lo­sis cas­es, and Covid-19 has raised fears that pre­vi­ous ef­forts to cur­tail TB will be ham­pered. The WHO said in May that an ad­di­tion­al 1.4 mil­lion peo­ple could die from TB with­in the next five years as a di­rect re­sult of the Covid-19 pan­dem­ic.

→ The Alzheimer’s Drug Dis­cov­ery Foun­da­tion has sealed sev­er­al part­ner­ships with Roche, Sh­iono­gi, J&J’s Janssen and Ei­sai to launch a biobank shar­ing pro­gram. Part of the Di­ag­nos­tics Ac­cel­er­a­tor, the ini­tia­tive aims to de­vel­op bet­ter bio­mark­er tests by an­a­lyz­ing blood and cere­bral spinal flu­id spec­i­mens from Alzheimer’s pa­tients in ear­li­er clin­i­cal tri­als.

The Ohio State Uni­ver­si­ty has spun a com­pa­ny out of Zhi­wei Hu’s lab, pro­vid­ing the seed fund­ing to run more pre­clin­i­cal stud­ies and scale up man­u­fac­tur­ing for his next-gen­er­a­tion tis­sue fac­tor (TF) im­munother­a­pies tar­get­ing triple-neg­a­tive breast can­cer, among oth­ers. Cin­cyTech, a lo­cal fund in Cincin­nati, led the fi­nanc­ing for Eikonok­lastes Ther­a­peu­tics, which is run by for­mer My­onexus ex­ec Bruce Hal­pryn.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.