Takeda Pharmaceutical’s soticlestat did not meet Phase 3 goals in Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. But the pharma giant points to results on secondary goals and subgroup analyses, and plans to discuss with regulators the “totality of data.”
Takeda Pharmaceutical has secured an option on an Alzheimer’s disease immunotherapy from AC Immune that is on track to report its first Phase 2 data later this quarter. Exercising the option would make Takeda responsible for Phase 3 testing of the therapy, putting AC Immune in line for up to $2.1 billion in milestone payments.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
Ono Pharmaceutical’s acquisition of Deciphera Pharmaceuticals adds to a cancer drug pipeline that already spans multiple modalities. Deciphera develops drugs that target the on-off switch of enzymes that drive cancer cell growth.
With the right solutions, providers can spend more time with the patient, building the relationship, earning their trust, and focusing on the forward-looking health journey.
Two Japanese pharmaceutical companies and a bank are teaming up to form a joint venture to advance therapeutic discoveries from academia. The focus will be innovation from universities in Japan.
The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
Orchard Therapeutics gene therapy Lenmeldy won FDA approval for treating the rare enzyme deficiency metachromatic leukodystrophy. In January, Kyowa Kirin completed its acquisition of Orchard, which now operates as a subsidiary of the Japanese drugmaker.
Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019.
FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.
Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.2, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this target include AstraZeneca and Bristol Myers Squibb.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
After paying $4 billion up front, Merck will share in the development and commercialization of three Daiichi Sankyo cancer drugs in the red-hot field of antibody drug conjugates, or ADCs. The most advanced of them is on track for an FDA submission in 2024.
Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.
A schizophrenia drug candidate from partners Sumitomo Pharma and Otsuka Pharmaceutical failed to outperform a placebo in two Phase 3 studies. The compound is the most advanced program from a psychiatry and neurology collaboration spanning four drugs discovered by an artificial intelligence technology platform.
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
Astellas has become an active player in gene therapy. MedCity News caught up with company executive Richard Wilson, who explained Astellas’s strategy, the clinical holds on its two most advanced programs, and the rationale behind its recent gene therapy deals.