BioSpace News Archive

Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.

Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced that the European Medicines Agency (EMA) issued a positive opinion on the Company’s application for orphan designation for SYNB1618 for the treatment of phenylketonuria (PKU).

Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), today announced that Health Canada has approved LUMIFY® (brimonidine tartrate ophthalmic solution 0.025% w/v), the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine tartrate to relieve redness of the eye due to minor eye irritations for adults.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that John Climaco , Chief Executive Officer of CNS Pharmaceuticals, will be participating at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually.

CASI Pharmaceuticals, Inc. today announced the signing of a Sublicense Agreement with Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd., (“TIANSHI”) a clinical stage pharmaceutical company organized and existing under the laws of the People’s Republic of China (“PRC”).

inHEART, a privately-held medical device company delivering the world’s most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance for its inHEART MODELS software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the designation of Schirmer test, a measure of tear production, as the sole primary endpoint in the Phase 3 TRANQUILITY-2 clinical trial of reproxalap in patients with dry eye disease.

Cosette Pharmaceuticals, Inc (“Cosette”), in collaboration with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals (“Alembic”; BSE: 533573), announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for an NBE version of Abreva® (Docosanol cream 10%) in a 2 gm tube and pump formats.

Pancryos today announced that it has executed a global exclusive license with Brigham and Women’s Hospital for the first in class convection-enhanced macroencapsulation device.

Illumina, Inc., a global leader in DNA sequencing and array-based technologies, announced the addition of a companion diagnostic indication to its CE-marked in vitro diagnostic TruSight™ Oncology Comprehensive test.