Industry

In-house Microbiology laboratory commissioned to accelerate product range development and enhance differentiation Experienced microbiologists will ensure drug substance quality control, perform analytics research on potential drugs, and advance new applications for proprietary form of hypochlorous acid Introduction of the new team underscores SpectrumX’s commitment to strict analytical and quality control methods, which will allow the … [Read more…]

Initiative to develop, manufacture, and validate publicly available somatic reference samples and create public genomic datasets with the potential to be used by sponsors and regulators ARLINGTON, Va.–(BUSINESS WIRE)–#MDIC–The Medical Device Innovation Consortium (MDIC) formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project to improve the validation and regulatory review process for … [Read more…]

DUBLIN–(BUSINESS WIRE)–The “Molecular Diagnostics Market Size, Share, Trends, By Product & Services, By Technology, By Application, By End-use and By Region Forecast to 2030” report has been added to ResearchAndMarkets.com’s offering. The global molecular diagnostics market size is expected to reach USD 50.94 Billion in 2030 and register a revenue CAGR of 12.4% over the … [Read more…]

Rezafungin is a next-generation, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia The European Medicines Agency (EMA) filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin demonstrated non-inferiority to the current standard of care, caspofungin in the treatment … [Read more…]

PLEASANTON, Calif.–(BUSINESS WIRE)–Astex Pharmaceuticals, Inc. (Astex) today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the initial treatment of adults with acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy. The current standard of care … [Read more…]

– European Commission Grants Marketing Authorization for Sunlenca, Helping to Address a Critical Unmet Clinical Need for People with Multi-Drug-Resistant HIV Who Have Very Limited Treatment Choices – FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted Marketing Authorization for Sunlenca® (lenacapavir) injection and tablets for the … [Read more…]

U.S. District Court for the District of Delaware rules Teva Pharmaceuticals infringes VFMCRP patent Disputes with all other Abbreviated New Drug Application (ANDA) filers regarding Velphoro® have been settled ST. GALLEN, Switzerland–(BUSINESS WIRE)–Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in … [Read more…]

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced 2022 mid-year results which ended on June 30, 2022. Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: “The announcement of 2022 mid-year results coincides with our seventh anniversary. In the challenging macro environment, we continue to … [Read more…]

In a new monkeypox advocacy ad in the Los Angeles Times (Sunday, August 21), AHF faults L.A. County Public Health for taking a top-down approach, dictating to the community rather than enlisting those groups as partners Stating that public health is the most basic responsibility of government, AHF’s ad also admonishes county officials to “Put … [Read more…]

Adds two board-certified vein surgeons in NW Portland & Happy Valley PORTLAND, Ore. & HAPPY VALLEY, Ore.–(BUSINESS WIRE)–Inovia Vein Specialty Centers announces two new board-certified surgeons that have joined its fast-growing team. Lauren Wikholm, MD, leads Inovia’s Happy Valley clinic. She is a member of the American Venous & Lymphatic Society and an experienced surgeon … [Read more…]