European Medicines Agency Accepts Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis

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…]

European Medicines Agency Commences Review of Oral Fixed-Dose Combination of Decitabine and Cedazuridine for the Treatment of Adults with Acute Myeloid Leukemia

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…]

Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option

– 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…]

VFMCRP announces U.S. Court upholds validity of Velphoro® patent

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…]

InnoCare Releases 2022 Mid-Year Results and Business Highlights

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…]

L.A. Needs New Leadership on Monkeypox, HIV and STDs

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…]

Inovia Vein Specialty Centers Expands Surgical Team

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…]

Digital Medicine Leader Akili to List on Nasdaq Following Successful Business Combination with Social Capital Suvretta Holdings Corp. I

Akili, Inc. common stock to begin trading on Nasdaq under the ticker symbol “AKLI” on August 22, 2022 Total gross proceeds of more than $163 million will support launch of first FDA-cleared video game treatment and advancement of late-stage pipeline BOSTON & PALO ALTO, Calif.–(BUSINESS WIRE)–$DNAA #DTx–Akili, a leading digital medicine company, today completed its … [Read more…]

Legend Biotech Announces Participation in Upcoming Investor Conferences

SOMERSET, N.J.–(BUSINESS WIRE)–Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced its participation in the upcoming investor conferences: Event: Citi’s 17th Annual BioPharma Conference Location: Boston, Massachusetts Fireside Chat Date & Time: Wednesday, September 7, 2022 at 11:20am ET Presenter: Ying … [Read more…]

Ohio State Wexner Medical Center, Kindred Rehabilitation Services Plan New Rehabilitation Hospital

COLUMBUS, Ohio–(BUSINESS WIRE)–The Ohio State University Wexner Medical Center announces it is partnering with Kindred Rehabilitation Services (KRS), a business unit of LifePoint Health, to build and operate a new 80-bed, 86,000 square foot adult inpatient rehabilitation hospital in Columbus. The facility will specialize in treatment and research for patients with stroke, brain and spinal … [Read more…]