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Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Familial Chylomicronemia Syndrome is a rare condition that can have deadly symptoms.

Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint of reducing Positive and Negative Syndrome Scale scores after six weeks of treatment for schizophrenia.

The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.

The campaign is focused on providing guidance for newly diagnosed patients.

Agents were informed that they would no longer receive commissions for select signs up as of November 1.

In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.

Submissions to the FDA and EMA for new indication of Darzalex Faspro are based on results of the Phase III Aquila trial in patients with high-risk smoldering multiple myeloma.

The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal atrial fibrillation.

At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed the potential of mRNA technology in developing cancer vaccines amid distrust from the public.

At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed ways to prepare for the high number of incoming patent expiries and how to protect key drugs.

The latest news for pharma industry insiders.

At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed initiatives aimed at bringing cell and gene therapies to low- and middle-income countries.

At the Financial Times’ Global Pharma and Biotech Summit 2024, a breakout panel discussed how dealmaking remains vital for biopharma companies facing pipeline and revenue pressures.

At the Financial Times’ Global Pharma and Biotech Summit 2024, Christophe Weber, president and CEO, Takeda, discusses how trust and collaboration between the biopharma industry and stakeholders can be implemented to support successful healthcare transformation.

Ron Lanton, Partner, Lanton Law, discusses the legal implications of the FDA’s broad label challenge to PD-1 inhibitors for gastric cancers.

Abi Carter is timing the partnership with the release of her upcoming album.

The healthcare company signed a deal with Infirmary Health, who services customers in Georgia and parts of Florida and Mississippi.

Results from the VENTURE Phase II trial and a Phase I oral formulation study found that VK2735, a novel a dual GLP-1 and GIP receptor agonist, demonstrated promise in treating obesity.

Results from Part I of the Phase III ESSENCE trial found that Wegovy 2.4 mg achieved a 37% improvement in liver fibrosis without worsening steatohepatitis in patients with metabolic dysfunction-associated steatohepatitis compared to 22.5% in the placebo group.

The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or mild dementia associated with Alzheimer disease based on data from the Clarity AD study.

The deal is expected to leverage EvolveImmune's T-cell engager EVOLVE platform to develop novel antibody-based therapies for solid and hematologic malignancies.

The trials will investigate datopotamab deruxtecan in combination with treatments including rilvegostomig, osimertinib, and chemotherapy in patients with nonsquamous non-small cell lung cancer.

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix's superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Roxybond is the and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation designed to reduce abuse of pain medication via intranasal and intravenous routes.

CMG1A46 is currently being developed for B cell-driven autoimmune diseases, primarily systemic lupus erythematosus and lupus nephritis.

Collaboration seeks to advance the treatment of non-small cell lung cancer by combining Keytruda with Moderna’s novel neoantigen therapy, which has shown positive results across cancer types.

Acquisition includes Aliada’s lead asset, ALIA-1758, which is being developed for the treatment of Alzheimer disease.

Under terms of the deal, Richter will receive an upfront cash payment of $25 million, along with potential future development, regulatory, and commercialization milestones.

Growth is expected due to increased instances of chronic diseases such as cancer and Alzheimer disease.