Press Releases

Yunovia, a drug R&D subsidiary of Ildong Pharmaceutical Group, announced on the 26th that the Ministry of Food and Drug Safety (MFDS) of Korea has cleared the IND application of Phase 1 Multiple Ascending Dose (MAD) study for ID110521156, an orally available small molecule GLP-1 agonist being developed for obesity and diabetes following the successful completion of the Phase 1 Single Ascending Dose (SAD) study. Phase 1 MAD study will be conducted to evaluate the safety, tolerabi

Regeneron Pharmaceuticals, Inc today announced that the European Commission  has approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell. &ld

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer" has been approved. The corresponding Phase III clinical s

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the "A Randomized, Open-label, Phase III Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Cervical Cancer Who Progressed on or after Platinum-based Chemotherapy" has been approved. The company will initiate

The U.S. Food and Drug Administration (FDA) has approved and granted  emergency use authorization (EUA) for the updated mRNA COVID-19 vaccines (2024-2025 formulation) to include a monovalent (single) component that corresponds to the SARS-CoV-2 omicron KP.2 variant strain. The mRNA COVID-19 vaccines have been updated with this formulation to more closely target currently circulating variants and provide better protection against severe COVID-19 outcomes, including hospitalization and dea

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the humanized amyloid-beta (Aβ) monoclonal antibody “Leqembi®” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.1 Lecanemab is indicated for the treatment of mild cognitive impairment (MCI)

Borealis stems from the success of Chinook Therapeutics, a kidney disease company founded by Versant in 2019 and acquired by Novartis in 2023. Following the acquisition, Novartis quickly recognized the substantial scientific potential of legacy Chinook early research talent, site facilities and capabilities in Vancouver, and came together to finance the launch of Borealis. “Accelerating science is our north star at Novartis. The creation of Borealis as an independent follow-on

AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma (SEA). The approval is based on results from the MIRACLE Phase III trial, which was conducted in China, South Korea and the Philippines.2 In the trial, Fasenra achieved a statistically significant and clinically meaningful 74% reduction (0.49 in the

PhotonPharma, a cutting-edge biopharmaceutical company based in Fort Collins, Colorado, is pleased to announce the successful closing of a $2.5 million seed financing round. This vital funding will support the Phase I clinical trial of Innocell™, an innovative therapy for the treatment of advanced ovarian cancer. According to the National Cancer Institute (https://seer.cancer.gov/statfacts/html/ovary.html) ovarian cancer will impact 19,680 women in the US with 12,740 deaths in 2024 alon

Touchlight, an innovation-driven contract development and manufacturing organization (CDMO) specializing in enzymatic DNA production, is proud to announce the clinical supply of its proprietary dbDNA™ to the University of Nottingham for research and development of a next-generation DNA vaccine targeting the Zika virus.  Scientists from the University of Nottingham are leading the development of a Zika virus DNA vaccine that can be manufactured within weeks and safely depl