Search Results for “EC” – Page 322 – media

New Sample Preparation Solutions Simplify and Automate Respiratory Diagnostic Testing

Clinical laboratories performing respiratory testing are required to generate results of the highest quality results. Now, an automated nucleic acid purification instrument along with kits for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens has been designed to fulfill the requirements of these laboratories. Thermo Fisher Scientific Inc. (Waltham, MA; USA) has launched the high-throughput, versatile KingFisher Apex Dx system that allows scientists’ labs to recover quality nucleic acids for sensitive downstream applications with maximum consistency, reproducibility, and reliability. The system has been designed to be a part of modular sample preparation for real-time PCR analysis workflow, providing precise results, accurate data management, and robust security features that meet cybersecurity and diagnostic regulatory standards. Additionally, Thermo Fisher has launched the MagMAX Dx Viral/Pathogen NA Isolation kit which offers advanced formulation to ensure reproducible results and is automation-compatible with the KingFisher Apex Dx. These products together ...
- Source: drugdu
- 108
- December 15, 2023
Glycan analysis holds promise for early diagnosis of various cancers

In the future, a little saliva may be enough to detect an incipient cancer. Researchers at the University of Gothenburg have developed an effective way to interpret the changes in sugar molecules that occur in cancer cells. Glycans are a type of sugar molecule structures that is linked to the proteins in our cells. The structure of the glycan determines the function of the protein. It has been known for a while that changes in glycan structure can indicate inflammation or disease in the body. Now, researchers at the University of Gothenburg have developed a way to distinguish different types of structural changes, which may provide a precise answer to what will change for a specific disease. “We have analyzed data from about 220 patients with 11 differently diagnosed cancers and have identified differences in the substructure of the glycan depending on the type of cancer. By letting our newly ...
- Source: drugdu
- 98
- December 15, 2023
MAPS Seeks Approval of First Psychedelic-Assisted Therapy for PTSD

Pharmaceutical Executive Editorial Staff MAPS Public Benefit Corporation filed a new drug application for MDMA (midomafetamine capsules) for use with psychological intervention for the treatment of post-traumatic stress disorder. MAPS Public Benefit Corporation has submitted a new drug application (NDA) to the FDA in what would represent the first approved psychedelic treatment for post-traumatic stress disorder (PTSD). MAPS is seeking approval of MDMA (midomafetamine capsules) for use with psychological intervention comprised of psychotherapy and additional supportive services provided by a qualified healthcare provider for PTSD.1 MAPS was previously granted Breakthrough Therapy Designation by the FDA for MDMA and is seeking a priority review for the NDA submission. “The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” Amy Emerson, ...
- Source: drugdu
- 96
- December 15, 2023
Sanofi Abandons Deal for Rare Disease Drug Amid FTC’s Monopoly Concerns

Sanofi, which markets the two primary treatments for Pompe disease, was trying to add a third one by licensing rights to a Maze Therapeutics drug candidate with a different therapeutic approach. A Federal Trade Commission complaint alleges the deal amounts to a monopoly player taking out its competition. By FRANK VINLUAN Sanofi is walking away from a deal to license an experimental Maze Therapeutics drug for a rare enzyme deficiency after the Federal Trade Commission challenged the transaction as anti-competitive. The French pharmaceutical giant already markets Lumizyme and Nexviazyme for the disorder, called Pompe disease. Until this year, they were the only available Pompe treatments. In an administrative complaint filed Monday, the anti-trust regulator said Sanofi’s deal for Maze’s drug candidate amounts to a large company trying to eliminate a smaller competitor. Both Sanofi and Maze disagree with the FTC’s position. South San Francisco-based Maze said it is reviewing its ...
- Source: drugdu
- 100
- December 15, 2023
Sino Biopharm’ S&P ESG Score Gains Another Boost, Stays in Top 9% Globally

Recently, S&P Global Corporate Sustainability Assessment (CSA) has been releasing the results of 2023 Environmental, Social and Governance (ESG) scores. Sino Biopharm (HK.1177) has achieved a second consecutive year of improved ratings. This year, the Group’s rating steadily improved to 55 points, up 10 points from the previous year, and ranked in the top 9% globally for the second consecutive year. The S&P Global Corporate Sustainability Assessment is one of the world’s largest annual assessments of corporate sustainability practices, which comprehensively reflects the level of ESG management and disclosure of companies through quantitative scoring of companies’ ESG management and performance, and is an important basis for investment decisions and data analysis by global investors. 2023, approximately 350 companies in the pharmaceutical industry around the world were invited to participate in the assessment. For two consecutive years, the company has outperformed 91% of its global peers, representing the organization’s high recognition ...
- Source: drugdu
- 95
- December 15, 2023
Mayor of Bogota, Colombia, Claudia Lopez and Ambassador of Colombia, Sergio Cabrera and his entourage visited SINOVAC.

On the afternoon of December 5, 2023, Claudia Lopez, Mayor of Bogota, Colombia, and Sergio Cabrera, Ambassador of Colombia to China, visited SINOVAC, accompanied by Ruth Amparo Medina, Director of International Relations of Bogota City, Oscar Felipe Rueda, Commercial Counselor of the Embassy of Colombia in China, and Daniel Mesa, First Secretary of the Embassy. Accompanied by Yin Weidong, Chairman, President and CEO of the company, Yang Guang, Chief Commercial Officer, and Gao Qiang, Chief Operating Officer. Previously, SINOVAC successfully won the bidding for the Bogotá Vaccine Plant Project (“Bogotá Project”) and entered into a strategic cooperation with the Bogotá Municipal Government, in which the two parties set up a joint venture company, BogotáBio, to promote the localized production of a variety of vaccines and new vaccines in Colombia. The joint venture, BogotáBio, will promote the local production of various vaccines in Colombia as well as the research and development ...
- Source: drugdu
- 91
- December 15, 2023
126 new drugs were included, with an average price reduction of 61.7% during negotiations…

On December 13, the National Medical Insurance Administration announced that the adjustment of the national basic medical insurance, work injury insurance and maternity insurance drug catalogs in 2023 has been successfully completed. The new version of the catalog will be implemented on January 1, 2024. In this adjustment, a total of 126 drugs were newly added to the national medical insurance drug catalog, and 1 drug was removed from the catalog. 143 drugs outside the catalog participated in negotiations or bidding, of which 121 drugs were successfully negotiated or bid. The negotiation success rate was 84.6%, and the average price reduction was 61.7%. The success rate and price reduction were basically the same as in 2022. After this round of adjustments, the total number of drugs in the national medical insurance drug catalog has reached 3,088, including 1,698 Western medicines and 1,390 Chinese patent medicines; there are still 892 types ...
- Source: drugdu
- 120
- December 15, 2023
BMJ probe questions oversight of UK pharmacy materials on Wegovy amid illegal ad accusations

A BMJ investigation has shone a spotlight on the marketing of semaglutide in the U.K., raising questions about the effectiveness of regulatory oversight of materials on the weight loss and diabetes treatment. Novo Nordisk is the marketing authorization holder for semaglutide, the active ingredient in diabetes drug Ozempic and obesity therapy Wegovy, but the results of online searches for the molecule include pharmacy websites unrelated to the drugmaker. The BMJ looked into whether any of those pages break the rules on the advertising of prescription drugs and how authorities in the U.K. respond to allegations of illegal promotion. A complaint filed by academics in the U.K. and Sweden forms the centerpiece of the report. Writing to the U.K. drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the academics said they were “appalled” to find Pharmadoctor, a provider of clinical services to pharmacists, was marketing Wegovy “directly to the ...
- Source: drugdu
- 194
- December 15, 2023
After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case

After last year’s explosive ruling to overturn the historic abortion ruling reached in Roe v. Wade, abortion access is back up for debate in the Supreme Court. This time, the FDA’s power is on the table, too. The United States’ highest court has agreed to review a Fifth Circuit appeals ruling that restricted access to Danco Laboratories’ abortion pill mifepristone and called the FDA’s regulatory authority into question, an order list (PDF) shows. Specifically, the appeals court’s prior ruling cut down the FDA’s approval for the pill to be delivered by mail, a call the agency made after the Supreme Court overturned Roe v. Wade. It also shrank the time frame the med can be used during pregnancy from 10 weeks to 7 weeks. The Fifth Circuit called the FDA’s approval process for the expanded access flawed and said the agency exceeded its authority. However, the appeals court did dismiss ...
- Source: drugdu
- 119
- December 15, 2023
【EXPERT Q&A】What is a pharmaceutical intermediate?

Drugdu.com expert’s response: A pharmaceutical intermediate is a substance that is produced during the synthesis of an active pharmaceutical ingredient (API) and is used in the further production of the API. These intermediates are crucial compounds in the drug manufacturing process, acting as pivotal building blocks that are transformed through various chemical reactions to form the final active ingredient. Pharmaceutical intermediates can vary widely in their complexity and are often produced in controlled conditions to ensure purity and quality. These intermediates are integral to the pharmaceutical industry, allowing for the efficient and cost-effective production of APIs. They play a significant role in the development of new drugs and formulations, providing flexibility and innovation in drug synthesis and design. The quality and control of pharmaceutical intermediates are vital, as they directly affect the efficacy, safety, and stability of the final pharmaceutical products. Manufacturers of pharmaceutical intermediates must adhere to strict regulatory ...
- Source: drugdu
- 239
- December 15, 2023
intermediate

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