The United States Patent and Trademark Office (USPTO) announced a pilot program to fast track appeals to the Patent Trial and Appeal Board (PTAB) from adverse decisions of examiners...
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By Pearce IP | Jul 09, 2020
The United States Patent and Trademark Office (USPTO) announced a pilot program to fast track appeals to the Patent Trial and Appeal Board (PTAB) from adverse decisions of examiners...
By Bioblast Editor | Jul 09, 2020
Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.
By Bioblast Editor | Jul 08, 2020
The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.
By Bioblast Editor | Jul 07, 2020
Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06....
By Bioblast Editor | Jul 07, 2020
Outlook Therapeutics announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).
By Naomi Pearce | Jul 06, 2020
Significant biosimilar activities this week include
28 Jun 20 | US Genentech filed a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung’s proposed bevacizumab biosimila...
By Pearce IP | Jul 06, 2020
The enlarged bench of the Full Court of the Australian Federal Court has clarified what constitutes infringement of Swiss-style claims in Mylan Health Pty Ltd v Sun Pharma ANZ Pty L...
By Bioblast Editor | Jul 05, 2020
In its 2019-2020 Annual Report, Biocon announced it plans to list Biocon Biologics on Indian markets within the next two to three years, depending on market conditions.
By Bioblast Editor | Jul 01, 2020
US Senators John Cornyn (R-TX) and Michael Bennet (D-CO) introduced the Increasing Access to Biosimilars Act, aimed at reducing the cost of prescription drugs for seniors. The proposed measures include promoting competition, increasing access to biosimilars, and encouraging...
By Bioblast Editor | Jul 01, 2020
The National Comprehensive Cancer Network (NCCN) announced it will collaborate with Pfizer Global Medical Grants to offer grants in support of the adoption of biosimilars in oncology. The NCCN has asked applicants to submit Letters of Intent which describe ‘concepts t...
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