Tag: drug

BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte^®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this product is planned for the third quarter of 2025.

- AGA2115 also received Orphan Drug Designation from European Medicines Agency

MAINZ and TÜBINGEN, Germany, June 12, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”) and CureVac N.V. (Nasdaq: CVAC, “CureVac”) today announced that they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on messenger ribonucleic acid (“mRNA”). The all-stock transaction will bring together two highly complementary companies based in Germany and will build on BioNTech’s proven track record and established position in the global mRNA industry.

Paris, France – June 12, 2025

Enterome SA, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, has raised $19 million in a new private financing to advance its lead clinical program EO2463 OncoMimics™ immunotherapy to treat indolent non-Hodgkin lymphoma (iNHL). The new funds will be used to expand and finalize the ongoing Phase 1/2 SIDNEY clinical trial of EO2463 and prepare the candidate for a registrational trial.

Leuven, Belgium, June 12, 2025 – AstriVax Therapeutics NV, a clinical stage immunotherapy company developing novel treatments for chronic infections based on its proprietary Launch-iT technology, announced today the appointment of Dieter Weinand as Chair of the Board of Directors, effective June 12, 2025. Mr. Weinand is the former Chief Executive Officer of Bayer Pharma AG with more than 25 years of experience as a senior business leader in the pharmaceutical industry. He takes over from Dr. Jeanne Bolger, who served as Chair since 2022 and will remain on the Board as a non-executive independent director.

BRUSSELS and CAMBRIDGE, Mass., June 12, 2025 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate. In the study, DZP demonstrated significant clinical improvements in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE), as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at Week 48, the primary endpoint. Improvements were also seen across additional clinical measures, including fatigue and disease activity/remission. These results were presented at EULAR 2025, the European Alliance of Associations for Rheumatology’s annual meeting, in Barcelona, Spain. The safety and efficacy of DZP in SLE have not been established, and it is not approved for use in SLE by any regulatory authority worldwide. A second Phase 3 trial of dapirolizumab pegol is ongoing with the goal of confirming the results from PHOENYCS GO.