Biotech Business - October 13, 2022
Mendus receives final grant payment
Mendus will receive 1.69 million EUR as the final grant payment from the Horizon 2020-funded AML-VACCiN project. All requirements for the final tranche have been fulfilled, bringing the total financial contribution from the European Commission to 6.0 million EUR for the project as a whole. As a result of the project completion, Mendus is now […]
Agreement - October 13, 2022
InfiCure Bio signs international agreements
The two agreements are with companies that are also active in the development of drugs for both liver and kidney fibrosis. “The contracts with our new clients clearly show that pharmaceutical companies continue to invest in the development of new drugs for fibrosis, which is extremely promising for InfiCure Bio,” says InfiCure Bio’s CEO, Sofia […]
Biotech Business - October 10, 2022
Guard Therapeutics receives IND approval
The U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for the investigational drug RMC-035 (ROSgard). The approval enables expansion of the clinical development program for RMC-035 to the US, including the ongoing global and placebo-controlled Phase 2 study AKITA in cardiac surgery, states the company in its press […]
Biotech Business - October 4, 2022
Oncopeptides starts commercialization of Pepaxti in Europe
The company has submitted the AMNOG dossier to “The Federal Joint Committee” (G-BA) in Germany. This initiates the commercial launch of Pepaxti (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched, states the company in a press release. “The launch of Pepaxti in Germany is an important […]
Pharma Business - October 3, 2022
SynAct Pharma submits IND for US clinical trial
SynAct Pharma has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its Phase 2a/b clinical trial RESOLVE with AP1189 in the United States. “We are happy to announce that we have now submitted the IND to the FDA in line with our previously […]
Pharma Business - September 26, 2022
Oncopeptides reports update from meeting with FDA’s ODAC
Oncopeptides has announced that the Oncologic Drugs Advisory Committee (ODAC), of the FDA, has finalized the discussion on the benefit-risk profile of Pepaxto. A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population. “We still have confidence in our science and data. The heart […]
