Johnson & Johnson New TECNIS Odyssey On September 30, 2024, Johnson & Johnson (JNJ) announced expanding the roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC - IOL), TECNIS Odyssey, in the U.S. TECNIS Odyssey IOL is built on the TECNIS platform, providing two . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Bristol-Myers Squibb COBENFY™ Approval Bristol Myers Squibb (BMY) announced that the U.S. FDA has approved COBENFY™ (xanomeline and trospium chloride) for schizophrenia in adults. Schizophrenia is a persistent disabling mental illness affecting how a person thinks, feels, and behaves. It is estimated to impact approximately 2.8 million people in the US. The initial symptoms appear in early adulthood and . . . This content is for …
Pfizer OXBRYTA® Worldwide Withdrawal Pfizer (PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA® (voxelotor) for the treatment of sickle cell disease (SCD) in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanding access programs worldwide. Pfizer's decision is based on the totality of clinical data, which currently indicates . . . This content …
IntraBio Inc in the NEWS IntraBio Inc. announced that the FDA has approved AQNEURSA (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg. IntraBio Inc., a US biopharmaceutical company, focused on the development of novel drugs addressing rare and common neurological diseases. IntraBio’s platform technologies result from decades of research and collaboration with …
UCB and Biogen Positive Results UCB (Euronext Brussels: UCB) and Biogen Inc. (BIIB) announced positive . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Sanofi Approval The United States FDA approved Sanofi (SNY) product Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). Sarclisa . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Aligos Therapeutics in the NEWS Yesterday, Sept. 19, 2024, Aligos Therapeutics (ALGS) - a small clinical-stage company, announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. Aligos Therapeutics is a clinical-stage biopharmaceutical company founded with the mission to improve patient outcomes by . . . This content is for …
AstaZeneca Fasenra Approval AstraZeneca (AZN) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval in the United States FDA was based on positive results from the MANDARA Phase III trial published in . …
Novartis FDA Approval Yesterday, September 17, 2024, Novartis (NVS) announced that the United States FDA has approved Kisqali®(ribociclib) in combination with an aromatase inhibitor (AI) for adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those . . . This content is for paid subscribers. Please click here …
AstraZeneca Imfinzi + Imjudo Updated results from the HIMALAYA Phase III trial have demonstrated that AstraZeneca (AZN) Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a sustained clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment. The results from HIMALAYA were presented at . . . …
Halozyme Therapeutics in the NEWS Halozyme Therapeutics, Inc. (HALO) announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of . . . This content is for paid subscribers. Please click here to subscribe …
Johnson & Johnson FDA Approval Yesterday, September 11, 2024, Johnson & Johnson (JNJ) announced that the FDA has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) - a chronic disease of the large intestine in which the lining of the colon becomes inflamed. About Ulcerative Colitis Ulcerative colitis is a form of inflammatory bowel . . . This …
Travere Therapeutics Approval Travere Therapeutics, Inc., (TVTX) announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. In February 2023, based on the surrogate marker of proteinuria, FILSPARI was granted accelerated approval. Now, full approval has been granted based on positive long-term confirmatory results . . . This …
Gilead Sciences and Genesis Therapeutics Gilead Sciences (GILD) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets. Genesis Therapeutics is pioneering generative and predictive artificial intelligence (AI) technologies to help create therapeutics for challenging targets. This collaboration will deploy Genesis’ field-leading AI platform . . . This content …
Regenxbio Positive Results Regenxbio (RGNX) announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for patients with Mucopolysaccharidosis Type 2 (MPS II), also known as Hunter syndrome. The results were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2024. The totality of evidence from the CAMPSIITE trial continues to . . . This content is for …
Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301 On August 28, 2024, Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech (KRYS) announced positive interim safety and efficacy results from both Cohorts 3 and 4 of PEARL-1, a Phase 1 study evaluating KB301, an investigational aesthetic treatment designed to deliver the COL3A1 transgene and increase type III collagen (“COL3”) levels in the …
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