Enforcement Report - Week of December 20, 2023
Sun Pharma`s Generic Pazopanib Receives Approval in the U.S.
Teva Pharma`s Generic Pazopanib Receives Approval in the U.S.
Health Canda Issues Recall of Pharmascience`s PMS-Pazopanib 200 mg tablet
RALEIGH, N.C. and SHANGHAI, March 16, 2019 /PRNewswire/ -- Xynomic Pharma, a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corp. (Nasdaq: BCAC), today jointly announced that China, Spain and Poland authorities have approved Xynomic's application to conduct potentially pivotal Phase 3 trial using Xynomic's abexinostat, in combination with pazopanib, in patients with renal cell carcinoma (RCC). Xynomic plans to initiate this trial in China, Spain, Poland and additional European countries in the first half of 2019. The same trial is currently ongoing in the United States and South Korea. According to a June 2018 research report by Grand View Research, RCC accounts for 1.8% of total adult malignancies globally and 3.4% of all new cancer cases in the United States. The global RCC pharmaceuticals market size is projected to reach US$ 4.6 billion in 2019.
China is quickly approving many of the newest cancer drugs but it also is demanding big discounts if drugmakers want them on its national insurance coverage list. In fact, in the latest round of negotiations, drugmakers offered up discounts averaging 56.7% for medications that included blockbusters from Novartis, Pfizer and AstraZeneca.
U.S.-China biotech Xynomic Pharma has raised additional funding to take an HDAC inhibitor in-licensed last year into seven new cancer trials.
With early news of presentations being announced today at the American Society of Clinical Oncology (ASCO) Annual Meeting in the first week of June, it can be hard to nail down which ones are going to be significant. But sometimes the sheer number of presentations are indications of a company’s numerous cancer programs. Basel, Switzerland-based Novartis announced that between the ASCO meeting and the 23rd Annual Congress of the European Hematology Association (EHA) meeting being held June 14 to 17 in Stockholm, Sweden, it will be presenting 84 abstracts.
Shares of Agile Therapeutics Inc. ( AGRX ) got pounded in extended trading on Tuesday despite positive results from SECURE, the company's phase III trial of its once-weekly contraceptive patch Twirla.