BioSpace News Archive

The Antimicrobials Working Group (AWG) announced today the addition of Entasis Therapeutics Inc. (Entasis) to its coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations.

Shortly after WAT Medical’s leading product to treat nausea-induced vomiting, EmeTerm, received its FDA clearance earlier in April, it has now also received official clearance from Health Canada.

Already Exceeds Trump Administration’s Plan for Pharmacy Benefit Managers

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) and an Intention to Grant from the European Patent Office (EPO) for two new patents covering RHB-104, expected to be valid until at least February 5, 2029, once granted.

The FDA withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017, after receiving public comments and the only citizen petition (FDA-2018-P-1876) filed by Sarfaraz K. Niazi.

Eric Eichenwald, MD, FAAP, chief of the division of Neonatology at Children’s Hospital of Philadelphia (CHOP), and author of the American Academy of Pediatrics (AAP) guidelines on Diagnosis and Management of Gastroesophageal Reflux in Preterm Infants, published recently, is available to speak with media.

Largest Verdict In The USA for 2018 Fieger hails jurors as heroes

Insulet has established a dedicated Customer Care team, committed to providing best-in-class support to its large European customer base.

First Phase III immunotherapy study to demonstrate a statistically significant progression-free survival (PFS) improvement in intention-to-treat (ITT) and PD-L1 positive first-line metastatic triple negative breast cancer (TNBC) populations

Rekovelle’s unique dosing algorithm, which is based on a woman’s anti-Müllerian hormone (AMH) level and body weight, is designed for predictable ovarian response