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Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.

Biohaven is proposing troriluzole for the treatment of spinocerebellar ataxia, a group of rare, genetic diseases that lead to the progressive loss of control over movement.

Arena launched with $500 million in early 2024 to fund basic biological research, from which it planned to spin out dedicated companies to focus on drug development.

Harmony Biosciences has paused a mid-stage trial of ZYN002 in 22q11.2 deletion syndrome after the THC-free cannabinoid drug failed to significantly improve social avoidance in a late-stage study in fragile X Syndrome.

Amgen remains confident in its obesity asset MariTide, for which it has launched a broad Phase III program.

Due to the litigation Pfizer filed Friday and Monday against Metsera, Novo Nordisk and the biotech’s lead shareholder, CEO Albert Bourla was limited in what he could say. But he said Pfizer was the best fit for Metsera.

Both companies have submitted revised bids, with Novo’s coming in $1.9 billion higher than Pfizer’s.

The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy.

Sarepta nevertheless plans to push for full FDA approval of Vyondys 53 and Amondys 45 based on what it said are “encouraging trends” in efficacy.

Kygevvi is indicated for patients with thymidine kinase 2 deficiency whose symptoms arise by 12 years of age. The disease manifests as muscle weakness and can become life-threatening in severe instances.

Had Pfizer’s Freda Lewis-Hall not stepped in, SpringWorks’ rare disease treatment may never have reached patients. Pharmas can act now to help find the next Gomekli.

Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.

- The ESC M&PD meeting brings together the world’s experts working to improve the treatment of myocarditis and pericarditis. - Presentation to provide comprehensive findings from the ARCHER trial following the reporting of topline results demonstrating a notable improvement in extracellular volume and a significant reduction in left ventricular mass. - The Company will host a webcast conference call on December 1, 2025, to discuss the ARCHER findings and their significance, and to highlight the positive implications for Cardiol’s programs in inflammatory heart disease.