Author: Prohost

Vera Therapeutics Announces Expanded Atacicept Development Program in Multiple Autoimmune Kidney Diseases

 Vera Therapeutics in the NEWS Today, October 02, 2024, Vera Therapeutics (VERA) announced the expansion of its development pipeline for its lead asset, atacicept. This program is expected to build on the positive data reported to date from the ongoing ORIGIN Phase 2b and 3 clinical program developing atacicept to treat patients with IgAN, by extending into a broader population of IgAN and . . …

Johnson & Johnson Rolls Out New TECNIS Odyssey, Next-Generation Intraocular Lens, Offering Cataract Patients Precise Vision at Every Distance in Any Lighting

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.

The United States FDA Approved Bristol Myers Squibb’s COBENFY™ – A First-In-Class Muscarinic Agonist for Schizophrenia in Adults

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Pfizer Has Voluntarily Withdrawn All Lots of its Sickle Cell Disease Treatment OXBRYTA® from Worldwide Markets

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 …

The FDA Approved IntraBio Product AQNEURSA As the only treatment for Niemann-Pick Disease Type C

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 …

Sanofi Product Sarclisa Approved in the US as the First anti-CD38 Therapy

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 Announces Positive Topline Results from Phase 2A Herald Study of ALG-055009 for the Treatment of MASH

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 …

AstraZeneca Product Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis 

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 . …

The U.S. FDA Approves Novartis’ Kisqali® to Reduce the Risk of Recurrence in People with HR+/HER2- Early Breast Cancer

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’s Imfinzi + Imjudo Demonstrated Unprecedented Overall Survival in Advanced Liver Cancer

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 Announced FDA Approval of Roche’s Tecentriq Hybreza with ENHANZE

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 Product TREMFYA® Receives U.S. FDA Approval

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 Announces Full FDA Approval of FILSPARI®

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 Therapeutics and Genesis Therapeutics Announced Strategic Collaboration to Discover and Develop Novel Therapies

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 Announces Positive Results of its Product RGX-121 for Hunter Syndrome  

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: Reversing the Biology of Aging Skin to Meet the Growing Demand

 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 …

Merck Discontinues Two Late-Stage Keytruda Trials and Other Important Information

Merck Updates Merck (MRK) provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, stating that it discontinued Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II non-small cell . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Good News for Vertex Pharmaceuticals and for Crispr Therapeutics

Vertex Announces CASGEVY™ Reimbursement Agreement with NHS England Vertex Pharmaceuticals (VRTX) announced a reimbursement agreement with NHS England for eligible transfusion-dependent beta-thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy, CASGEVY™ (exagamglogene autotemcel).  The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted CASGEVY the first authorization in the world for a CRISPR-based . . . This content is for paid subscribers. Please click here …

Gilead Sciences Livdelzi Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA

Gilead Sciences Approval Gilead Sciences (GILD) today announced that the U.S. FDA has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA taken alone, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended . . . This content is …