Don Tracy, Associate Editor

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

Ron Lanton, Partner, Lanton Law, ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.

Ron Lanton, Partner, Lanton Law, discusses potential challenges that will come as a result of the FDA’s recent move to tighten label restrictions on PD-1 inhibitors for gastric cancers.

Ron Lanton, Partner, Lanton Law, discusses why the regulatory body made the decision to place restrictions on PD-1 inhibitors for gastric cancers.

As the first major treatment to be approved for schizophrenia in over 30 years, Cobenfy is poised to set the stage for new approaches in treating mental health disorders.

The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.

Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino acid decarboxylase deficiency.

Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity.

Under terms of the collaboration, Merck will lead the development, manufacturing, and commercialization of LM-299, an investigational bispecific antibody.

Results from the Phase III KOMET trial found that Koselugo demonstrated a statistically significant objective response rate compared to placebo treating plexiform neurofibromas.

As part of the acquisition, BioNTech will obtain the rights to BNT327/PM8002, a bispecific antibody that targets PD-L1-low and -negative tumors that often resist checkpoint inhibitors.

Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a previously withdrawn application to the FDA for nonsquamous non-small cell lung cancer.

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.

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.

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.

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.

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.