Citius Pharmaceuticals Inc.’s retooled version of withdrawn cancer drug Ontak (denileukin diftitox) is not quite ready for prime time, according to the U.S. FDA, which issued a complete response letter (CRL) for the interleukin-2-diphtheria toxin fusion protein known as Lymphir. The agency is asking for Citius to incorporate enhanced product testing and additional controls but did not raise any concerns regarding safety and efficacy, the company said.
Notching another deal in its efforts to extend the global reach of toripalimab, Junshi Biosciences Co. Ltd. granted Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize the PD-1 inhibitor in a regional licensing agreement that could be worth as much as $728.3 million.
Notching another deal in its efforts to extend the global reach of toripalimab, Junshi Biosciences Co. Ltd. granted Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize the PD-1 inhibitor in a regional licensing agreement that could be worth as much as $728.3 million.
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). Both approvals, each for a rare disease indication, were granted based on phase II trial results, instead after the usual phase III trials.
NEW DELHI – India is taking a multipronged approach to developing and distributing vaccines against COVID-19, with at least 10 different products under development, domestically or through collaborations with foreign developers. Vaccinations are likely to begin early next year but, with a population of around 1.2 billion, it is unlikely India will be able to vaccinate everybody it needs to before the end of 2022.
NEW DELHI - In a bid to limit what is seen as excessive dependence on active pharmaceutical ingredients (APIs) from China, the Indian government has announced a $394 million scheme to promote the development of three bulk drug parks.
NEW DELHI - In a bid to limit what is seen as excessive dependence on active pharmaceutical ingredients (APIs) from China, the Indian government has announced a $394 million scheme to promote the development of three bulk drug parks.