BioSpace News Archive

Last year, the FDA declined to approve a drug that appears to reverse a rare and debilitating enzyme deficiency. Some experts say it’s emblematic of a need for more flexibility around therapeutics targeting rare diseases.

Dialysis giant DaVita on Thursday raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.

The biotech will pause its lirafugratinib program for a rare bile duct cancer to target a larger FGFR2-altered solid tumors population, citing the Inflation Reduction Act as a driving decision factor.

The German biotechnology company has teamed with Suzhou-based biotech MediLink Therapeutics to develop next-generation antibody-drug conjugates for cancer.

The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor.

The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal.

The regulator’s approval of oral, once-daily etrasimod, to be marketed as Velsipity, was based on favorable Phase III safety and efficacy data showing significant clinical remission of ulcerative colitis.

Biomerica, Inc., a global provider of advanced medical diagnostic and therapeutic products reported financial results for the first quarter of fiscal 2024 ended August 31, 2023.

Enanta Pharmaceuticals, Inc., a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections, announced it will host a virtual key opinion leader event to discuss advances in the treatment landscape for RSV with global experts and highlight the company’s RSV pipeline.

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced upcoming data presentations for tenapanor for hyperphosphatemia at the American Society of Nephrology (ASN) Kidney Week 2023 meeting to be held in Philadelphia, PA, November 1-5, 2023.