Latest Specialty Pharmaceuticals News

Mayne Pharma has voluntarily withdrawn a speaker presentation for its contraceptive NEXTSTELLIS® following an FDA Untitled Letter concerning promotional claims. The company confirms this does not impact sales or its planned merger with Cosette.

Acrux Limited, partnering with TruPharma, has introduced its Dapsone 7.5% Gel in the US, featuring a unique tube packaging that aims to improve patient convenience and reduce environmental impact.

Mayne Pharma has announced the expiration of the US antitrust waiting period, a critical step forward in Cosette Pharmaceuticals' proposed acquisition. The transaction now moves closer to completion, pending other regulatory and shareholder approvals.

Acrux Limited has appointed John Warmbrunn as its new CEO and Managing Director, signaling a strategic push for international expansion and product development starting June 2025.

Medical Developments International reported a robust Q3 FY25 with $8.9 million revenue and $1.7 million operating cashflow, driven by strong Penthrox demand and pricing. New distribution agreements in France and Switzerland position the company for further European expansion.

BTC Health has transformed its decade-long license agreement with Arna Pharma into an indefinite partnership, gaining royalties from Singapore and Malaysia sales and first rights to new pharmaceutical products in Australia and New Zealand.

Mayne Pharma reports a robust first half of FY25 with revenues climbing to $210-$215 million and underlying EBITDA soaring by up to 300%, driven by strong performance in Women's Health.

Acrux Limited announces the retirement of CEO Michael Kotsanis after more than 10 years at the helm, with a search underway for his successor to lead the next phase of growth.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

Acrux Limited has launched its Nitroglycerin 0.4% Ointment and successfully raised nearly $4 million, positioning the specialty pharma company for sustained revenue growth.