News

While all eyes were on the Supreme Court of the United States’ ruling in the much-anticipated Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, the Court issued a second key ruling this week in SAS Institute v Iancu, Director, United States Patent and Trademark Office, et al—one that will also impact inter partes review (IPR) of biologic drug patents.
The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), an umbrella organization that represents 34 patient associations around the world, recently released a report on healthcare inequities among nations and regions. In the report, the EFCCA identified disparities in access to biologics and biosimilars
In a letter last week, patient advocacy group Patients for Affordable Drugs (P4AD) called on the Federal Trade Commission (FTC) to examine whether a pay-for-delay deal allegedly struck between reference adalimumab (Humira) manufacturer AbbVie with biosimilar developer Samsung Bioepis violates anti-competitive and antitrust laws.
 
Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.
The Supreme Court of the United States (SCOTUS) ruled today in the case of Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, that the inter partes review process for reviewing patents does not violate the Constitution by adjudicating public rights outside of an Article III court. The Court ruled 7 to 2, with Chief Justice John Roberts and Justice Neil Gorsuch dissenting.
 
A case series was recently published in CNS Oncology that investigated whether adult pilocytic astrocytoma—a rare and highly vascular tumor—is responsive to bevacizumab treatment.
 
Australia has been seeking to support the approval and uptake of biosimilar medicines as a way to alleviate pressure on its national health system.
After spinal cord injury, oxidative stress, inflammation, and mitochondrial dysfunction can cause neural damage that was once believed to be both immediate and irreversible. However, neuronal death is now believed to proceed over a period of several days after initial trauma, and to include cellular, molecular, and biochemical cascades, including local inflammatory responses. Tumor necrosis factor is believed to be involved in the local production of cytokines at the site of the injury.
Pfizer announced this morning that the FDA has issued a Complete Response Letter for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin.
 
This week, Scott Gottlieb, MD, Commissioner of the FDA, addressed the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, and made his case for increased funding for the FDA.
 
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