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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
100 Results
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Theratechnologies Announces Results from Trogarzo® (Ibalizumab-uiyk) Intramuscular Administration Study
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX) today announced results from a study evaluating an intramuscular (IM) method of administration for Trogarzo® (ibalizumab-uiyk), a monoclonal antibody antiretroviral therapy (ART) for the treatment of heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.
October 13, 2023
·
7 min read
Genetown
Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination Process
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its initial negative opinion on the Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name ALBRIOZA®.
October 13, 2023
·
7 min read
Genetown
Foghorn Therapeutics Announces Clinical Data From Phase 1 Study of FHD-286 in Metastatic Uveal Melanoma to Be Presented at ESMO Congress
Foghorn® Therapeutics Inc. (Nasdaq: FHTX) today announced that clinical data from the dose escalation and expansion study of FHD-286 in metastatic uveal melanoma (mUM) will be presented at the ESMO Congress 2023, to be held October 20–24 in Madrid, Spain.
October 13, 2023
·
3 min read
Job Trends
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaExpressing PD-L1 (CPS ≥1)
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA.
October 13, 2023
·
46 min read
Prominent U.S. hospital expands RayStation installation for proton treatment planning
RaySearch Laboratories AB announces that the Mass General Cancer Center plans to expand its use of RayStation®* to proton treatment planning.
October 13, 2023
·
2 min read
Drug Development
Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis.
October 13, 2023
·
10 min read
Drug Development
Inmagene Doses First Patient in Phase 2a Trial of IMG-007, an Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Alopecia Areata
Inmagene Biopharmaceuticals (“Inmagene”), a clinical stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, announced that the first patient has been dosed in a global multicenter Phase 2a study of IMG-007 in adult patients with AA.
October 13, 2023
·
4 min read
Actinogen to present progress on Phase 2 trials at the BIO Investor Forum, San Francisco and Clinical Trials on Alzheimer’s Disease (CTAD) Conference, Boston
Actinogen Medical Limited (ASX: ACW) CEO Dr Steven Gourlay will conduct a series of meetings at the BIO Investor Forum, San Francisco on October 17-18, 2023.
October 13, 2023
·
8 min read
Biotech Beach
Shimadzu Medical Systems USA installs first TRINIAS SCORE OPERA Cardiac Catheterization Lab in the US
Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, is proud to announce the first U.S. installation of a Trinias SCORE Opera C12 (ceiling-mounted cutting edge angiography system) at Beaufort Memorial Hospital (Beaufort, SC).
October 13, 2023
·
4 min read
Drug Development
Harmony Biosciences Announces Topline Data From Phase 3 Intune Study Evaluating Pitolisant in Patients With Idiopathic Hypersomnia
Harmony Biosciences Holdings, Inc., a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, announced topline results from the INTUNE study in patients with idiopathic hypersomnia.
October 13, 2023
·
13 min read
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