Janssen Pharmaceutical Cos. Inc. has become the second company to get a BCMA-targeting CAR T therapy to market with the approval of ciltacabtagene autoleucel for adults with relapsed or refractory multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altpep, Diadem.
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
PERTH, Australia – Biopharma stakeholders are furious about the consultation process the Australian government has pursued with its review of the country’s National Medicines Policy, and they are asking the government to hold off on making any changes until after the federal election that is scheduled for May.
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28.
The U.S. Patent Trial and Appeal Board’s (PTAB) decision Feb. 28 that Broad Institute scientists were the first to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells is just another chapter in the ongoing saga of who has patent rights to various elements of the CRISPR platform.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Harbour Biomed, JW, Lexicon, Merck KGaA, Reata.
With the first global approval by Health Canada in hand, Medicago Inc. aims to provide 20 million doses this year of Covifenz – which itself represents another first, as a plant-originated, virus-like particle, recombinant, adjuvanted COVID-19 vaccine. “Hopefully, if all goes well, we’ll be able to do it faster than the last day of the last month” of the year, said Brian Ward, medical officer of Quebec City-based Medicago, a unit of Mitsubishi Tanabe Pharma Corp., which partnered on Covifenz with Glaxosmithkline plc (GSK).
After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. reported that they have a sufficient level of participation to move forward with a $5 billion nationwide settlement to resolve opioid-related claims and litigation by states, cities, counties and other government subdivisions in the U.S.
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