Oct 23, 2021 | International
The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping and subsidizing of certain container chassis originating in or exported from People’s Republic of China have caused injury or retardation or are threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that preliminary determinations had been made respecting the dumping and subsidizing of the above-mentioned goods.
Ottawa, Ontario, October 22, 2021—The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping and subsidizing of certain container chassis originating in or exported from People’s Republic of China have caused injury or retardation or are threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that preliminary determinations had been made respecting the dumping and subsidizing of the above-mentioned goods.
On February 18, 2022, the Tribunal will determine whether the dumping and subsidizing have caused injury or retardation or are threatening to cause injury to the domestic industry.
The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.
Any interested person, association or government that wishes to participate in the Tribunal’s inquiry may do so by filing a Form I – Notice of Participation. For details on the specific products under inquiry or for more information, visit the Tribunal’s website.
Oct 4, 2021 | International
The Canadian International Trade Tribunal today initiated an expiry review of its finding made on October 20, 2016, in Inquiry No. NQ-2016-001, to determine if the expiry of the finding is likely to lead to continued or resumed dumping of welded large diameter carbon and alloy steel line pipe from the People’s Republic of China and Japan, and the subsidizing of these goods from the People’s Republic of China, and is likely to result in injury.
Ottawa, Ontario, September 27, 2021—The Canadian International Trade Tribunal today initiated an expiry review of its finding made on October 20, 2016, in Inquiry No. NQ-2016-001, to determine if the expiry of the finding is likely to lead to continued or resumed dumping of welded large diameter carbon and alloy steel line pipe from the People’s Republic of China and Japan, and the subsidizing of these goods from the People’s Republic of China, and is likely to result in injury.
On February 24, 2022, the Canada Border Services Agency will determine if there is a likelihood of resumed or continued dumping and subsidizing. In the event of positive determinations, the Tribunal will determine, on August 3, 2022, whether the continued or resumed dumping and subsidizing are likely to result in injury.
The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.
Any interested person, association or government that wishes to participate in the Tribunal’s expiry review may do so by filing Form I – Notice of Participation. For details on the specific products under review or for more information, visit the Tribunal’s website.
Sep 30, 2021 | International
The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping of oil country tubular goods originating in or exported from the United Mexican States has caused injury or retardation or is threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that a preliminary determination had been made respecting the dumping of the above-mentioned goods.
Ottawa, Ontario, September 29, 2021—The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping of oil country tubular goods originating in or exported from the United Mexican States has caused injury or retardation or is threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that a preliminary determination had been made respecting the dumping of the above-mentioned goods.
On January 26, 2022, the Tribunal will determine whether the dumping has caused injury or retardation or is threatening to cause injury to the domestic industry.
The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.
Any interested person, association or government that wishes to participate in the Tribunal’s inquiry may do so by filing a Form I – Notice of Participation. For details on the specific products under inquiry or for more information, visit the Tribunal’s website.
Sep 29, 2021 | Business
Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (early AD). The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. The lecanemab Phase 2b trial results demonstrated a high degree of Abeta plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. AD is a serious, progressive and devastating disease with few treatment options. Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new treatment option to people living with early AD, their families and healthcare professionals.
In June, 2021, lecanemab was granted Breakthrough Therapy designation, which is an FDA program intended to expedite the development and review of medicines for serious or life threatening conditions. Eisai has an agreement with the FDA to submit the BLA for lecanemab as a rolling submission. This agreement allows completed portions of the application to be submitted to the FDA for review on an ongoing basis. After all portions are submitted to the FDA and the agency accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.
The BLA submission for lecanemab is primarily based on the results of the proof-of-concept Study 201 in 856 patients with mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology. The results were published in a peer-reviewed journal in April 2021.1 Study 201 explored the impact of treatment with lecanemab on reducing brain Abeta and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer’s Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. The rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with amyloid targeted therapies, for the 10 mg/kg biweekly dosing was 9.9%.
After completion of the Core period and a Gap period off treatment (average of 24 months), all 180 patients in the Study 201 open-label extension study received 10 mg/kg biweekly lecanemab dosing. The data confirmed lecanemab produces reductions of amyloid PET SUVr, with significant reduction occurring as early as 3 months, and >80% of subjects achieved amyloid negative status by visual read in as early as 12 months [https://www.eisai.co.jp/ir/library/presentations/pdf/e4523_210730.pdf]. Significant amyloid reduction relative to placebo in those exposed to lecanemab in the Core period was maintained while off-treatment over the Gap period. The rate of ARIA-E was consistent with the Core study at around 10%.
The lecanemab Clarity AD Phase 3 clinical trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The U.S. FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD will be included to support the BLA.
“With the worldwide population growing and aging, the number of people living with AD is on the rise. AD imposes an enormous burden on not only people living with AD and their families but also for society. We recognize the strong and urgent expectations from stakeholders to further advance a treatment system for this disease. For many years, Eisai has endeavored to understand the anxieties of people living with AD and has been conducting research and development of novel therapies,” said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for AD. As part of our human health care mission, we are committed to bringing new medicines to people living with AD and their families as early as possible.”
“The Alzheimer’s community welcomes scientific innovation that creates more treatment options for people living with this terrible neurodegenerative disease,” said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, University of Nevada Las Vegas. “Based on the efficacy and safety results of the Phase 2b study and preliminary results from the open-label extension study, I am optimistic about the potential lecanemab may have as a treatment choice for patients with early Alzheimer’s to ameliorate the otherwise inevitable decline they face.”
“It is our vision that patients and their families have choice and access to multiple treatment options for Alzheimer’s disease. The rolling submission of lecanemab for FDA review under the accelerated pathway is a positive step toward that goal,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We believe that treatments directed at amyloid beta reduction in the brain have the potential to transform diagnosis and treatment of Alzheimer’s disease. We look forward to continuing to work with Eisai to pioneer science, advance knowledge, and serve the needs of Alzheimer’s patients.”
Aug 31, 2021 | International
The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping of certain small power transformers, originating in or exported from the Republic of Austria, the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu (Chinese Taipei), and the Republic of Korea, has caused injury or is threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that a preliminary determination had been made respecting the dumping of the above-mentioned goods.
Ottawa, Ontario, August 30, 2021—The Canadian International Trade Tribunal today initiated an inquiry to determine whether the dumping of certain small power transformers, originating in or exported from the Republic of Austria, the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu (Chinese Taipei), and the Republic of Korea, has caused injury or is threatening to cause injury. This final injury inquiry was initiated further to a notice received from the Canada Border Services Agency stating that a preliminary determination had been made respecting the dumping of the above-mentioned goods.
On December 24, 2021, the Tribunal will determine whether the dumping has caused injury or retardation or is threatening to cause injury to the domestic industry.
The Tribunal is an independent quasi-judicial body that reports to Parliament through the Minister of Finance. It hears cases on dumped and subsidized imports, safeguard complaints, complaints about federal government procurement and appeals of customs and excise tax rulings. When requested by the federal government, the Tribunal also provides advice on other economic, trade and tariff matters.
Any interested person, association or government that wishes to participate in the Tribunal’s inquiry may do so by filing a Form I – Notice of Participation. For details on the specific products under inquiry or for more information, visit the Tribunal’s website.
