Latest Pharmaceuticals News

The Takeovers Panel has declared unacceptable circumstances in the Mayne Pharma acquisition after Cosette Pharmaceuticals changed its intentions to close the Salisbury manufacturing site, raising concerns over market transparency and regulatory approval.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.

Mayne Pharma updates investors on the extended FIRB approval deadline and potential financing hurdles in its proposed acquisition by Cosette Pharmaceuticals.

Antaria has disclosed several FDA-identified GMP compliance issues but assures no impact on product quality or supply, committing to expert-led remediation and enhanced training.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Algorae Pharmaceuticals has launched a Loyalty Options Offer, allowing eligible shareholders to purchase options at a nominal price, aiming to reward loyalty and support future growth funding.

The Takeovers Panel has issued interim orders extending the deadline for Mayne Pharma's takeover scheme with Cosette Pharmaceuticals, preventing termination without consent and maintaining the status quo.

The Takeovers Panel has intervened in the Mayne Pharma and Cosette Pharmaceuticals scheme, issuing interim orders that extend the deal deadline and restrict termination rights to maintain the status quo.

Starpharma’s 2025 AGM highlighted breakthrough partnerships and clinical progress, positioning the biotech for growth. Key deals with Genentech and Radiopharm Theranostics underpin a promising pipeline and expanding revenue streams.

The Foreign Investment Review Board has extended its deadline for approving Mayne Pharma's acquisition by Cosette Pharmaceuticals, maintaining the current transaction timetable for now.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

The FDA's removal of the black box warning on hormone replacement therapies marks a pivotal shift for Mayne Pharma, potentially unlocking new market opportunities and reshaping women’s health treatment.