BioSpace News Archive

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations.

Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for orphan designation for the use of Mycapssa® in the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET).

LIfT BioSciences is pleased to announce that it’s lead investor, Starbloom Capital, has provided further investment into the Company to accelerate LIfT’s R&D plans and progress N-LIfT, the Company’s first-to-market anti-cancer innate cell therapy, into clinical development by Q1 2024, within 15 months after demonstrating strong preclinical results.

Pfizer will now lead all development and commercialization activities in Mainland China, Hong Kong, Macau, and Singapore LianBio will receive a $20 million upfront payment, to be released from previously restricted cash paid by Pfizer to LianBio in 2020 under the companies’ existing strategic collaboration.

BioXcel Therapeutics, Inc. today announced that the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 (dexmedetomidine) sublingual film, the Company’s proprietary, orally dissolving film, under investigation for the acute treatment of agitation in patients with Alzheimer’s disease (AD).

BioVaxys Technology Corp. and Procare Health Iberia, of Barcelona, Spain announced today that they have finalized and executed the United States Distribution Agreement (“Distribution Agreement”) for Papilocare® and Oral Immunocaps©.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported positive results in a Phase III clinical study of Fanapt ® (iloperidone tablets), a novel atypical antipsychotic, in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults.

Repare Therapeutics Inc. today announced that they have established new Automatic Securities Disposition Plans (“ASDPs”), or in the case of Maria Koehler modified her existing ASDP, in accordance with applicable United States and Canadian securities legislation.

Frequency Therapeutics, Inc. today announced that it has established a Clinical Advisory Board to help guide its remyelination in multiple sclerosis (MS) program.

Senti Biosciences, Inc. today announced that Tim Lu, MD, PhD, Co-founder and Chief Executive Officer, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 5:15 p.m. PT.