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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
- 102
- 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
- 100
- 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
- 94
- 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
- 127
- December 15, 2023
Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023

Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online. GC012F demonstrated a 100% overall response rate (ORR) and 95% ...
- Source: drugdu
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- 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
- 200
- 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
- 123
- December 15, 2023
Discover the Advanced Medical Centrifuge Solutions from Hunan Kecheng Instrument Equipment Co., Ltd.

Hunan Kecheng Instrument Equipment Co., Ltd., a leading manufacturer of medical centrifuges, is delighted to showcase its extensive range of products, including high-speed centrifuges, low-speed centrifuges, refrigerated centrifuges, blood bank centrifuges, and more. Our centrifuges are designed to cater to the needs of hospital laboratories, medical laboratories, and beauty institutions worldwide. Understanding that choosing the right centrifuge can be challenging, our low-speed centrifuges are tailored for hospital laboratories, especially for vacuum blood collection tube separation. We offer a unique solution with an automatic uncapping feature post-centrifugation, enhancing efficiency and reducing manual effort. Our patented rotor design for automatic uncapping includes multiple capacities, catering to different hospital requirements. Our product line includes: TD4K blood card special centrifuge: Ideal for blood type serology, routine blood tests, and immunoassays. TD4B cell smear centrifuge: Extensively used in immune blood laboratories for red blood cell serology and antigen identification. 3-5N urine sediment centrifuge: A ...
- Source: drugdu
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- 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
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- December 15, 2023
intermediate
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune

Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
- Source: drugdu
- 130
- December 14, 2023

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