Regulatory
No safety issues were cited. Instead, it appears related to the company’s proposal to modify the trial’s analysis plan and various chemistry, manufacturing and controls (CMC) issues.
Patent broadens protection in infectious disease, including composition of matter claims
Potential New Indication Would Expand Use to Allow Treatment-Experienced Adults Living with HIV-1 Whose Virus is Suppressed to Switch to PIFELTRO (in Combination with Other Antiretrovirals) or DELSTRIGO
Taiwan Liposome Company, Ltd. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for TLC178 for the treatment of soft tissue sarcoma.
Translate Bio did not provide information as to what questions or concerns the FDA has regarding the planned early-stage trial for mRT5201.
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
As opioid lawsuits continue to wind through the courts, some drugmakers are focused on developing treatments for opioid addiction.
The partial government shutdown is 31 days old, yet the U.S. Food and Drug Administration has maintained a steady list of drug approvals throughout that time. However, that approval rate could change next month.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee had a split vote, 8 to 8, on whether the overall benefits of Zynquista (sotagliflozin) outweiged the risk in order to support approval. This sends things back to the agency to make a final decision, which has a target action date of March 22, 2019.
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