BioSpace News Archive

Eyenovia, Inc. (NASDAQ: EYEN), today announced that MydCombi, the company’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, has been reclassified as a drug-device combination product by the U.S. Food and Drug Administration (FDA) in a Complete Response Letter (CRL) for the company’s new drug application (NDA) received on October 22, 2021.

Allakos Inc. today announced that its poster, “High Discovery Rate of Eosinophilic Gastritis and/or Duodenitis Among Patients with Chronic Unexplained Gastrointestinal Symptoms,” received a Presidential Poster Award at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Spectral Medical Inc. today announced that Chris Seto, Chief Executive Officer of Spectral, will present at the Benzinga Global Small Cap Conference which is being held virtually on October 27-28, 2021.

TCR2 Therapeutics Inc., a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors, announced a clinical trial collaboration agreement with Bristol Myers Squibb to evaluate gavo-cel in combination with Opdivo® and Yervoy® in its planned Phase 2 clinical trial in treatment refractory mesothelin-expressing solid tumors.

Mallinckrodt plc, a global biopharmaceutical company, announced results from a retrospective medical chart review study examining treatment patterns and outcomes in hospitalized patients with esophageal variceal hemorrhage and liver cirrhosis treated with terlipressin.

Boehringer Ingelheim marks the World Health Summit 2021 by announcing updates to its strategic approach to sustainable development

Merck, known as MSD outside the United States and Canada, announced positive top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens or bictegravir/emtricitabine/tenofovir.

Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), today announced the presentation of clinical data supporting CP101 for the prevention of recurrent C. difficile infection (CDI) at the American College of Gastroenterology (ACG) Annual Scientific Meeting being held October 22-27, 2021 in a hybrid format.

Clinical Laserthermia Systems AB (publ) (CLS), developer of high precision, image-guided focal laser ablation (FLA) systems, today announced that a new generation of its TRANBERG® Thermal Therapy System is being evaluated for MRI-US, fusion-guided laser ablation for the minimally-invasive, targeted focal therapy of prostate tumors.

uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the third quarter of 2021 and highlighted recent progress across its business.