media – Page 195 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

【EXPERT Q&A】What documents and certifications are needed, and what are the main processes for exporting pharmaceuticals to Canada?

Drugdu.com expert’s response: Exporting pharmaceuticals to Canada requires adherence to specific processes and regulations. Here are the key steps for exporting pharmaceuticals to Canada: Understanding Canadian Regulations: Before exporting, familiarize yourself with the pharmaceutical regulations and regulatory requirements of Canada. Health Canada is the regulatory authority responsible for formulating and enforcing policies on drug imports. Familiarity with these regulations is essential to ensure that the exported pharmaceuticals comply with Canadian standards. Registration and Approval: Pharmaceuticals must be registered and approved by Health Canada before export. Depending on the type of drug, different application forms and materials may be required. Specific requirements can be found on Health Canada’s official website: https://www.canada.ca/en/health-canada.html Quality Management in Drug Production: Ensure that exported pharmaceuticals meet Canadian Good Manufacturing Practices (GMP). Exporting companies should regularly conduct internal audits to ensure compliance with GMP standards. Product Labeling and Instructions: Pharmaceutical labels and instructions must be prepared according ...
- Source: drugdu
- 204
- February 1, 2024
Pfizer’s layoff campaign ramps back up with dozens of SF-area cuts expected next month

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake.Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act (WARN) alert. That address matches the former headquarters of Global Blood Therapeutics, which Pfizer scooped up for $5.4 billion back in 2022. Along with the deal, Pfizer gained GBT’s marketed sickle cell disease drug Oxbryta. “As previously communicated, Pfizer has launched an enterprise-wide cost realignment program,” a Pfizer spokesperson said via email. The program will “result in some job loss across a number of our locations, including South San Francisco,” the spokesperson said.“Pfizer does not take these changes lightly,” she added. GBT’s Oxbryta won FDA approval in sickle cell disease back in 2019. When Pfizer closed its GBT buyout in October 2022, ...
- Source: drugdu
- 160
- January 31, 2024
Grifols files lawsuit against hedge fund for making ‘false and misleading statements’

Spanish plasma medicines producer Grifols is clapping back at Gotham City Research, filing a lawsuit that accuses the New York hedge fund of “knowingly making false and misleading statements” about the company “to manipulate the value of Grifols’ stock for their own monetary gain.” The complaint, filed in federal court in the Southern District of New York, comes in response to a report from Gotham on Jan. 9 which accused Grifols of wrongful accounting practices.Gotham called Grifols shares “uninvestable,” and over the next several days the report triggered a drop in Grifols shares of more than 30% and a freefall of its market cap from $7.6 billion to $4.6 billion. In reaction to the Gotham report, in a regulatory filing to Spain’s stock market watchdog CNMV, Grifols called it “false information” and “speculation.” The accounting questions raised by Gotham surround Grifols’ 2018 acquisitions of Haema AG and Biotest though its subsidiary Scranton Enterprises. In essence, Gotham said Grifols has underreported ...
- Source: drugdu
- 187
- January 31, 2024
Groundbreaking CRISPR Technology Could Revolutionize Diagnosis of Genetic Diseases

Diagnosing rare genetic diseases presents a significant challenge due to their complex and often hidden nature. These conditions can arise from a diverse array of genetic variations, many of which are uncommon or specific to each individual, complicating the identification of the exact cause of symptoms. Until recently, unraveling these mysteries involved extensive genetic testing and comparing an individual’s genetic profile against established disease patterns. Complicating matters further, many relevant genes are inactive in commonly tested tissues like blood and skin, which makes it difficult to get a clear picture of the genetic basis of these diseases. This complexity not only prolongs the diagnostic process but also extends patient and family uncertainty and delays the initiation of suitable treatments. Now, a new study could mark a significant step forward in the rapid and efficient diagnosis of these complex diseases, which can affect any part of the body. At Aarhus University ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800054/groundbreaking-crispr-technology-could-revolutionize-diagnosis-of-genetic-diseases.html
- 146
- January 31, 2024
Hengrui Medicine’s immunosuppressant tacrolimus sustained-release capsules were approved for marketing in the United States

Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
- Source: drugdu
- 119
- January 31, 2024
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 139
- January 31, 2024
EMA to support establishment of the African Medicines Agency

EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors. The European Commission’s Directorate-General for International Partnerships has signed an agreement with EMA marking the official launch of the project.AMA will be a specialised agency of the African Union (AU) dedicated to improving equitable access to quality, safe and effective medical products in Africa. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the coming months. The creation of AMA is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions. Cooperation and collaboration are in the DNA of the European medicines ...
- Source: drugdu
- 93
- January 31, 2024
New Adjuvanted Recombinant Herpes Zoster Vaccine Phase I Clinical Study in China Completes Enrollment of First Batch of Subjects

At the kick-off meeting held at the Center for Disease Control and Prevention in Pu’er City, Yunnan Province, regarding the REC610 China Phase I clinical trial project, the investigator introduced the background of the disease, information about the REC610 product, and gave a detailed introduction of the overall design of the clinical trial, the trial process, and the precautions and other aspects of the clinical trial. After the meeting, the research team sorted out the trial process to support the smooth development of the subsequent trial. REC610 carries a novel adjuvant, BFA01, developed by the Company, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, and is intended to be used for the prevention of herpes zoster in adults aged 40 years and above. Previously, data from an interim analysis of the FIH clinical trial of REC610 in the Philippines using GlaxoSmithKline ...
- Source: drugdu
- 103
- January 31, 2024
Hengrui Pharmaceuticals’ Immunosuppressant Tacrolimus Extended-Release Capsules Approved for U.S. Marketing

Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceuticals Co., Ltd. has received notification from the U.S. Food and Drug Administration (FDA) that the company’s abbreviated new drug application (ANDA, i.e., U.S. generic application) for the filing of tacrolimus extended-release capsule has been approved for production and marketing in the U.S. market. The product is indicated for use in combination with other immunosuppressive agents for the prevention of graft rejection following kidney transplantation in adults. The Company’s tacrolimus extended-release capsule is the first generic of this product approved for marketing by the U.S. FDA, and is also the first generic product approved for marketing in China. Tacrolimus is the core basic immunosuppressant after transplantation, which belongs to calmodulin neural phosphatase inhibitor (CNI), and its mechanism of action is to inhibit the expression and/or production of various cytokines, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., by inhibiting the activity of calmodulin phosphatase, and ...
- Source: drugdu
- 83
- January 31, 2024
EMA Grants Bersiporocin Orphan Drug Designation

Mike Hollan The agency recognized the medication as a significant advancement for the treatment of IPF. Daewoong Pharmaceuticals The European Medicines Agency (EMA) granted its orphan drug designation to bersiporocin, a medication developed by Daewoong Pharmaceuticals. The drug earned the title for its treatment of idiopathic pulmonary fibrosis (IPF). Daewoong Pharmaceuticals describes the drug as the world’s first PRS inhibitor for IPF. In a press release, Daewoong Pharmaceutical CEO Seng-ho Jeon said, “With Bersiporocin’s global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease.” IPF is a rare disease and only has about 13 cases per 100,000 people across the entire planet. It is a serious condition and the 5-year survival rate is about 40%. Patients with the condition suffer from a reduction of lung function due to a build-up of ...
- Source: https://www.pharmexec.com/authors/mike-hollan
- 105
- January 31, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.