BioSpace News Archive

BAQSIMI is expected to be available in U.S. pharmacies within one month

Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.

It is approved for adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

In terms of modernizing frameworks, Sharpless focused on the agency’s efforts to approve generic drugs and biosimilars more quickly in order to lower drug prices. He also said the FDA needed to help the biopharma industry with “the most expensive part of drug discovery and development,” referring to clinical testing.

Braeburn has been fighting the FDA over its award of Orphan Drug Designation to another opioid use disorder treatment that will prevent competition through November 2020. More than 2 million people in the U.S. have been diagnosed with the disease.

The FDA advisory committee canceled the meeting after Intra-Cellular provided the regulatory agency with additional data. No new meeting date has been scheduled.

The company’s focus is on improving immuno-oncology therapies, making them more effective for the patients for whom these new therapies don’t work and by decreasing serious side effects.

Following additional study, Freenome said it plans to seek regulatory approval under the Parallel Review Program, the first application of its platform in colorectal cancer screening.

As 2019 enters its second half, BioSpace takes a look at some of the warning letters issued by the U.S. Food and Drug Administration to the biopharma industry.

Patents and intellectual property protections are a big deal in the biopharma industry. One reason is simply the timeline of drugs and therapeutics. Biopharma has several unique challenges, but one of them is the patent cliff.