BioSpace News Archive

Drug Development

FDA Lifts Hold on Sarepta’s DMD Trial Following Protocol Adjustments

The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.

September 6, 2022
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1 min read
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Paul Elias
Drug Development

Gilead, Merck, Daiichi Sankyo and more Preview ESMO Presentations

Gilead, Merck, Daiichi Sankyo, HUTCHMED and BMS previewed data to be presented at the European Society for Medical Oncology Congress 2022, taking place Sept. 9-13.

September 6, 2022
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5 min read
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Alex Keown
Drug Development

FDA Okays Imfinzi as First Immunotherapy for Advanced Biliary Tract Cancer

The FDA approved AstraZeneca’s Imfinzi plus with gemcitabine-cisplatin chemotherapy as the first immunotherapy for adult patients with locally advanced or metastatic biliary tract cancer.

September 6, 2022
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2 min read
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Tristan Manalac
Drug Development

Athira Moves Forward with Alzheimer’s Candidate as a Monotherapy - Updated

Athira Pharma announced Tuesday it will study the stand-alone effects of its Alzheimer’s candidate fosgonimeton (ATH-1017). The drug failed to meet the endpoint in a Phase II study earlier this year.

September 6, 2022
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2 min read
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Paul Elias
Pixium Vision announces participation in upcoming investor conferences in September 2022

Pixium Vision SA, a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces that senior management will participate in the following investor conferences during September 2022:

September 6, 2022
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3 min read
Drug Development

Valneva Announces Publication of its COVID-19 Vaccine Phase 3 Data in The Lancet Infectious Diseases

Valneva SE, a specialty vaccine company, announces that The Lancet Infectious Diseases, a peer-reviewed medical journal, has published the Company’s pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001.

September 6, 2022
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4 min read
Business

Selvita exceeds its development strategy assumptions, estimates a 46%** increase in revenues in Q2 2022 and maintains high profitability

Selvita S.A., one of the largest contract research organizations in Europe, reported its preliminary financial results for Q2 and H1 2022*.

September 6, 2022
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7 min read
Drug Development

Laekna Announces First Patient Dosed in South Korea in LAE201INT2101 Phase 1/2 Study

Laekna, a clinical-stage biotechnology company dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide, announced yesterday that the first patient recently received a dose in the LAE201INT2101 phase I/II study at Seoul National University Hospital.

September 6, 2022
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2 min read
Theravance Biopharma to Present at Upcoming September 2022 Investor Conferences

Theravance Biopharma, Inc. will be participating in the following Fireside Chats, both of which will be webcast.

September 6, 2022
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1 min read
Drug Development

IDEAYA Announces First-Patient-In for Phase I Clinical Trial to Evaluate Darovasertib Monotherapy in (Neo)Adjuvant Uveal Melanoma

IDEAYA Biosciences, Inc. announced that it has initiated an Investigator Sponsored Trial, or IST, in coordination with St. Vincent’s Hospital, Sydney, to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma patients.

September 6, 2022
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6 min read