BioSpace News Archive

Approved earlier this month for children and adults with one or more food allergies, Xolair in a Phase III study reduced severe allergic reactions in patients suffering from multiple food allergies.

On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.

Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.

The oral antibiotic, which is also in development for uncomplicated urinary tract infections, demonstrated non-inferiority to the most common treatment for gonorrhea.

Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis.

Alamar Biosciences, a company powering precision proteomics to enable the earliest detection of disease, announced the first close of $100 million in Series C financing with the second close of an additional $28 million expected to happen within the next 30 days.

Talphera, Inc. (Nasdaq: TLPH), (“Talphera”), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will release fourth quarter and full-year 2023 financial results after market close on Wednesday, March 6, 2024.

Hologic, Inc. announced that the Company will present at the following upcoming investor conferences: Raymond James’ 45th Annual Institutional Investors Conference on Monday, March 4 at 8:40 a.m. Eastern Time.

Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).

Quanterix Corporation (NASDAQ: QTRX) today announced that it has rescheduled the release of its financial results for the fourth quarter and year ended December 31, 2023 and the associated conference call in order to more closely align the release of such results with the filing of its Annual Report on Form 10-K for the year ended December 31, 2023, the deadline for which is February 29, 2024.