Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Orchard Therapeutics has snapped up GlaxoSmithKline’s portfolio of approved and investigational rare disease gene therapies. The deal sees GSK become an investor in Orchard, with a 19.9 percent equity stake along with a seat on the firm’s board. The UK drugs giant also stands to receive royalties and commercial milestone payments related to the acquired portfolio.
Today the company has found some sure financial footing that will support its efforts through the remainder of the year. The company secured $163.7 million in an initial public offering. The funding will be used to continue the development of Cellectis’ off-the-shelf CAR-T products and drive them toward regulatory approval.
Novartis’ Afinitor Disperz has become the first medicine to be specifically approved by US regulators to treat patients aged two years and above with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
On April 6, 2018, the Food and Drug Administration(FDA) approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Application based on results from Phase 2 CheckMate -142 study
Boehringer Ingelheim, headquartered in Ingelheim, Germany, and OSE Immunotherapeutics, based in Nantes, Frances, signed a collaboration and license deal to jointly develop OSE-172 for myeloid cancers.
Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
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