Press Releases

Results of the Phase II study CONFIDENCE demonstrate that simultaneous initiation of finerenone and an SGLT-2-inhibitor (SGLT-2i) led to significant reductions in urine albumin-to-creatinine ratio (UACR) versus either agent alone in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) / These benefits were observed as early as 14 days after treatment initiation, supporting the potential of simultaneous initiation of finerenone and an SGLTI-2i / UACR is an early ind

Roche announced today that the European Commission (EC) has approved a label extension for Evrysdi® (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA). The 5mg tablet (approx. 6.5mm), which can either be swallowed whole or dispersed in water, can be taken with or without food and does not require refrigeration, when stored at room temperature. Administered at home, Evrysdi is the only non-invasive disease modifying treatm

Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT sig

Roche announced today positive results from the Phase III IMforte study of Tecentriq® (atezolizumab) in combination with lurbinectedin (Zepzelca®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq. The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy a

BioNTech SE and Bristol Myers Squibb today announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate. BioNTech’s BNT327, a next-generation bispecific antibody candidate targeting PD-L1 and VEGF-A,

Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS).   The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results

Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).[1] "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease fr

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a study of treatment patterns among patients with tardive dyskinesia (TD) residing in long-term care (LTC) facilities, highlighting a critical gap in TD diagnosis and treatment. "These results underscore the need for accurate diagnosis and timely treatment initiation for patients living with tardive dyskinesia in a long-term care setting,” said

Thermo Fisher Scientific Inc., the world leader in serving science, today launched the spectral-enabled Invitrogen™ Attune™ Xenith™ Flow Cytometer, allowing immunology and immuno-oncology researchers to automate and streamline workflows to obtain more detailed and accurate insights from critical cellular samples. By leveraging Thermo Fisher’s legacy core acoustic focusing technology, this new solution offers improved time to results for scientists researching cellular

Roche announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. The latest results for this investigational Bruton’s tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Phoenix, Arizona. “These