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The Latest Breaking News from Otsuka

The Difference the New ADHD Drug Named Simtriyo Makes and How It Works in the Brain

The FDA approved SIMTRIYO for ADHD in adults and children, offering a new three-neurotransmitter treatment while carrying important safety warnings.

Medical Daily · Aug 8

Simtriyo Will Be a Federally Controlled Substance, and Its DEA Schedule Will Shape How Easily Families Can Get It

Simtriyo cannot be filled until the DEA assigns a controlled substance schedule. What that means for access, timing, and two boxed warnings.

Medical Daily · Jul 30

The New ADHD Drug Carries Two Boxed Warnings and Will Be a Controlled Substance

The new ADHD drug Simtriyo carries two boxed warnings, pediatric suicidality monitoring, and CNS stimulant status pending DEA scheduling.

Medical Daily · Jul 30

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FDA Approves Centanafadine for ADHD: Who Qualifies, How It Differs, and What Side Effects Appeared

FDA-approved centanafadine, a first-in-class non-stimulant for ADHD in adults and children 6 and up over 20 kg. What families should know.

Medical Daily · Jul 27

FDA Set to Decide on a New Non-Stimulant ADHD Drug for Children and Adults on July 24

FDA decides on centanafadine July 24, 2026 — a first-in-class non-stimulant ADHD drug for children, adolescents, and adults. Four Phase 3 trials support the application.

Medical Daily · Jul 13

Antimicrobial resistance is outpacing the industry’s efforts to fight it, report finds

The antibiotic pipeline has shrunk 35 percent in five years, falling behind growing antimicrobial resistance worldwide, according to a new report.

Euronews · Mar 11

Psychedelics Management Updates: Two Top Companies Appoint New CEOs, Here's What We Know

Two companies in the psychedelics space have chosen new chief executive officers: COMPASS Pathways (NASDAQ: CMPS) has chosen Kabir Nath, and Small Pharma will be now led by George Tziras.

Benzinga · Jul 19, 2022

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The Daily Biotech Pulse: FDA Wants Omicron-Targeted COVID-19 Boosters, Provention Bio Clears Hits Hurdle For Diabetes Prevention Drug, Oxford Biomedica, AstraZeneca Strike Vaccine Pact

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga · Jul 1, 2022

Why Akebia Therapeutics Stock Is Soaring After Hours

Akebia Therapeutics Inc (NASDAQ: AKBA) shares are surging in Thursday's after-hours session after the company executed an agreement to terminate its Vadadustat collaboration and license agreements with Otsuka Pharmaceutical.

Benzinga · Jun 30, 2022

Why Are Akebia Therapeutics Shares Falling Today?

Akebia Therapeutics Inc (NASDAQ:AKBA) and Otsuka Holdings (OTC: OTSKY) separately announced to call for licensing and co-development agreement for vadadustat. Otsuka sent a written notice to Akebia on May 12 that the partnership had been terminated. Akebia said in an SEC filing filed Friday that the termination will go into effect in a year.…

Benzinga · May 16, 2022

Five Companies Developing Second Generation Psychedelics For Mental Health

Along with the psychedelic renaissance came a new type of drug: second generation psychedelics. Developed from classic psychedelics molecules, these upgraded compounds could offer improved therapeutic profiles with reduced side effects. For some companies in the psychedelics space, second generation psychedelics could be the key to success in an increasingly…

Benzinga · Mar 24, 2022

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