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Home » Topics » Regulatory

Regulatory
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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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Regulatory actions for March 1, 2022

March 1, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Harbour Biomed, JW, Lexicon, Merck KGaA, Reata.
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COVID-19 vaccine and syringe with flag of China

Mitsubishi, GSK harvest plant-based COVID-19 vaccine win in Canada

March 1, 2022
By Randy Osborne
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).
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FDA approved icons and medical professional

PERSIST-ence pays off as the FDA approves CTI’s cancer treatment

March 1, 2022
By Lee Landenberger
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.
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J&J’s $5B opioid settlement is on

Feb. 28, 2022
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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Aortic aneurysm illustration

US FDA eyes real-world surveillance for devices indicated for repair of AAAs

Feb. 28, 2022
By Mark McCarty
There are several devices on the market to repair the dreaded abdominal aortic aneurysm (AAA), but these carry some serious risks that have prompted multiple FDA advisories. The agency’s latest announcement recommends routine clinical follow-up for these patients for life, and the formation of a “real-world surveillance system” that may require the financial and technical assistance of industry and medical societies to develop.
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Chinese companies embrace stricter patent regulations

Feb. 28, 2022
By Zhang Mengying
Even as China sees strong and continuous growth in patent applications from its medical technology industry, regulators are imposing stricter regulations to curb what they see as "abnormal applications." China’s medical technology sector saw year-on-year growth of 28.7% in 2021 for valid invention patents, according to data from the China National Intellectual Property Administration.
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Stepped arrow

US FDA says first-cycle PMA major deficiency rates spiked in CY 2021

Feb. 28, 2022
By Mark McCarty
The U.S. FDA’s device center has posted a report on premarket review performance metrics under the current device user fee schedule, and the latest data show an 83% rate of deficiency in first-cycle reviews of PMA original filings in the last three months of calendar year 2021. That rate is down somewhat from the 91% rate seen in 2016, but is up substantially from the 63% major deficiency rate seen in 2018, the low-water mark for this metric for more than a decade.
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