Budesonide

The European Medicines Agency’s human medicines committee recommended approving six new medicines, including Moderna’s flu-Covid-19 combo vaccine and Novartis’ pill for hives. CHMP gives its recommendations to the European Commission, which has the final say on new drug approvals. The commission typically follows CHMP’s opinions. Moderna on Friday got a positive opinion for its first combined mRNA vaccine, called mCombriax , to protect against Covid-19 and influenza in patients aged 50 years and older. If approved, it would be the first single shot to protect against both diseases. As of Feb. 1, there have been more than 281 million cases of Covid-19 reported in Europe and 50 million cases of flu every year in the European Economic Area, according to the Friday release . In the US, Moderna has faced a more turbulent time with its flu-Covid shot. Last May, it pulled its biologics license application to wait for more efficacy data for the flu component of the vaccine. The company has yet to announce a resubmission, despite saying it intended to refile the BLA sometime in 2025. CHMP also recommended approving Novartis’ new oral drug Rhapsido as a treatment for the skin condition chronic spontaneous urticaria, or hives. Last September , Novartis secured FDA approval for Rhapsido as a treatment for hives that occur without any stimuli. Sanofi and Regeneron also got CHMP’s recommendation for Dupixent to be expanded to treat hives in children aged 2 to 11 years, making it the first pediatric therapy for this skin condition. Dupixent was approved in Europe to treat hives in adults in November last year. CHMP also recommended four other new drugs for approval: The committee also recommended extending five other labels:

TOKYO--(BUSINESS WIRE)-- Asahi Kasei Pharma, a global provider of healthcare and pharmaceutical solutions, in collaboration with Alchemedicine, has announced that its novel Endothelin A (ETA) receptor antagonist AK1960 has advanced to a Phase I clinical study following a successful preclinical phase. AK1960 is expected to be used in the treatment of various refractory diseases—medical conditions resistant to standard therapies. The initiation of a Phase I study is considered a significant step toward growing Asahi Kasei’s healthcare impact. AK1960 is a small molecule with a new core structure derived from Alchemedicine’s HiSAP™ 1 platform. It exhibits high selectivity, potent inhibition for the ETA receptor and has demonstrated efficacy in animal models for kidney diseases. AK1960 is expected to contribute to the treatment of various diseases which are difficult to control, such as refractory chronic kidney disease. In 2022, Asahi Kasei Pharma and Alchemedicine entered into an exclusive license agreement , with Asahi Kasei Pharma acquiring worldwide rights to develop and commercialize Alchemedicine’s ETA receptor antagonist. While preclinical and Phase I studies are performed in Japan, the program is intended for the global market. The Asahi Kasei Group will leverage Calliditas Therapeutics AB and Veloxis Pharmaceuticals, Inc . to advance the development of AK1960. “The advancement of AK1960 into a Phase I study reflects an important milestone for Asahi Kasei Pharma and demonstrates our close collaboration with Alchemedicine to address unmet medical needs,” said Yasuo Nakamura, Director and Senior Executive Officer at Asahi Kasei Pharma. “Since 2022, we have worked to overcome technical challenges, validate the therapeutic concept, and prepare for clinical evaluation. By leveraging the expertise of Calliditas and Veloxis in therapeutic development, we will continue advancing AK1960. Together, we are building a system that demonstrates scientific excellence while creating meaningful impact for real-world health settings.” Asahi Kasei positions Pharmaceuticals as a First Priority business in its medium-term management plan , emphasizing value creation by advancing high-impact therapies to address unmet medical needs globally. Recent examples of these activities include the start of Phase III study of ART-123 (Recomodulin™) in Japan for CIPN and the inclusion of TARPEYO® in the updated KDIGO Clinical Practice Guidelines . The initiation of a Phase I study for AK1960 reflects the company’s commitment to enhancing its Healthcare sector and pharmaceutical R&D capabilities intended to drive long-term, sustainable growth. To learn more about Asahi Kasei Pharma, visit About Asahi Kasei Asahi Kasei is a diversified global company that contributes to life and living for people around the world. Since its foundation in 1922, with businesses in ammonia and cellulose fiber, Asahi Kasei has consistently grown through proactive portfolio transformation to meet the evolving needs of every age. With 50,000 employees worldwide, the company contributes to sustainability by providing solutions to the world’s challenges across its three business sectors: Healthcare, Homes, and Material. For more information, visit . 1 HiSAP™ is a medicinal chemistry platform comprised of over 35,000 novel core scaffolds and an in-silico compound-design support system. HiSAP™ rapidly improves efficacy and/or safety issues of existing bioactive compounds across a broad range of therapeutic areas, sustaining desirable drug pro Contacts North America Contact: Asahi Kasei America Inc. Christian OKeefe christian.okeefe@ak-america.com Europe Contact: Asahi Kasei Europe GmbH Sebastian Schmidt sebastian.schmidt@asahi-kasei.eu