Wanbury's Tanuku facility in Andhra Pradesh completes ANVISA inspection with zero observations
According to Wanbury, the inspection concluded with zero observations, indicating full compliance with ANVISA's regulatory standards. The facility was evaluated for adherence to Current Good Manufacturing Practices (cGMP), which are required for pharmaceutical manufacturing.
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Following the inspection, ANVISA granted the Good Manufacturing Practices (GMP) Certificate to the Tanuku facility. The Certificate of Good Manufacturing Practices (Certificado de Boas Práticas de Fabricação – CBPF) has been issued in both English and Portuguese.
This certification is necessary for the export of pharmaceutical products to Brazil and demonstrates the facility's compliance with Brazilian regulatory requirements.
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OPM Announces Its 2025 Half-Year Financial Results and Provides an Update on Its Clinical Developments and Financial Position
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Karine LIGNEL, Managing Director and COO of Oncodesign Precision Medicine adds: "In a very difficult financial environment, we have taken management decisions that have enabled us to significantly reduce our expenses and thus extend our cash flow horizon as much as possible. We have also set up an equity financing line to deal with market uncertainties. Nevertheless, the situation remains complicated, and we are making every effort to secure a partnership for one of our assets." Key financial data A cost reduction program was implemented in the first half of 2025: Negotiations were held with the banks and BPI that granted the loan, resulting in a six-month deferral of principal repayments starting in April 2025 Expenses were reduced through The layoff of five employees in early 2025 A 50% reduction in the compensation of non-salaried corporate officers A freeze on salaries and bonus payments for the 2024 fiscal year A reduction in spending on non-priority programs. In terms of cash flow, rather than from an accounting perspective, this results in a reduction in payroll costs of €242k in the first half of 2025 and a projected reduction of €440k in the second half of this year. The reduction in expenditure is particularly significant for the item 'subcontracting and fees,' which will fall from €2,900k in the first half of 2024 to €1,773k in the first half of 2025. R&D expenses amounted to €1.74 million in the first half of 2025, compared with €3.61 million in the same period last year, as the company focused its efforts on the clinical development of OPM-101. Reintegration, in close collaboration with Servier, of all OPM-201 data and product stocks The most significant financial item in the first half of 2025 is the reintegration, as provided for in the partnership agreement, of the stock of OPM-201 GMP material produced by Servier. As this reintegration is being carried out without financial competing, OPM has called upon an external expert to determine fair value for these stocks. This expert carried out three different valuations to arrive at this fair value. A summary of these valuations is shown in the table below: The expert concluded that the fair value of these inventories falls within a range of €13 million to €16.2 million. OPM used the lower end of this range. OPM's revenue for the first half of 2025 was €0.1 million, the same as in the first half of 2024. Other income mainly consists of subsidies amounting to €0.3 million and €0.3 million in provision reversals. OPM's financial result was (€0.26) million, compared with (€0.1) million in the same period last year, mainly due to interest on outstanding loans and financial income from cash investments. OPM recorded €0.4 million in R&D tax credits in the first half of 2025, down 52% compared to last year. 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Some of these statements, forecasts and estimates can be identified by the use of words such as, without limitation, "believes", "anticipates", "expects", "projects", "plans", "seeks", "estimates", "may", "will" and "continue" and other similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were believed to be reasonable when they were made but which may not prove to be correct. Actual events are difficult to predict and may depend on factors beyond the Company's control. Consequently, the actual results, financial conditions, performance or achievements of the Company, or industry results, may differ materially from future results, performance or achievements as expressed or implied by such statements, forecasts and estimates. 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