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BioWorld - Thursday, June 26, 2025
Home » Topics » Regulatory

Regulatory
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Health Canada office sign

Canada’s COVID-19 interim orders giving way to regulations

March 2, 2022
By Mari Serebrov
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
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Regulatory actions for March 2, 2022

March 2, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acucort, Alnylam, Alvotech, Amneal, Amolyt, Anheart, Antengene, Aquestive, Ascletis, Astellas, Atara, Aytu, Biocardia, Cabaletta, Celyad, CTI, Design, Fera, Finch, Gilead, Harpoon, Hutchmed, Innocare, Innovent, Janssen, Karyopharm, Kempharm, Legend, Mydecine, Nicox, Pfizer, Radius, Redcloud, Regenerx, Statera, Urogen, Valneva, Zynerba.
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FDA to ask panel about QSR harmonization’s impact on US-only companies

March 1, 2022
By Mark McCarty
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
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U.S. FDA headquarters

FDA reviewers seen resurrecting trend of increasing demands for data

March 1, 2022
By Mark McCarty
The FDA has published an updated guidance for the appeals process at the Center for Devices and Radiological Health, but the issuance of that guidance did not happen in a vacuum. Mark Duval, president of Duval & Associates in Minneapolis, told BioWorld that industry is filing more appeals of premarket decisions of late, an uptick he said is an artifact of the practice of FDA reviewers more commonly asking for additional data for these applications.
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Janssen-Legend BCMA-targeting CAR T therapy crosses the line with US FDA approval

March 1, 2022
By Richard Staines and Michael Fitzhugh

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.


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Regulatory actions for March 1, 2022

March 1, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altpep, Diadem.
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U.S.-China capsule

China-US licensing trending up in China’s quest for innovation

March 1, 2022
By Mari Serebrov
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.
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Australian National Medicines Policy consultation process causes industry uproar

March 1, 2022
By Tamra Sami
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.
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U.S. FDA headquarters

US FDA issues CRLs to Reata, Amryt and GC Pharma

March 1, 2022
By Lee Landenberger

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. 


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US PTAB may have spoken, but CRISPR patent battle wages on

March 1, 2022
By Mari Serebrov
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.
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