Month: December 2024

Vertex Announces US FDA Approval of ALYFTREK™ Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis

Vertex Pharmaceuticals Vertex Pharmaceuticals (VRTX) announced a United States  FDA has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily triple combination Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Revisiting Bluebird Bio Inc

Bluebird Bio Inc For investors who thought that bluebird bio Inc (BLUE) stock price jumped up from less than $1, to over $7, we inform those who didn't know and remind those who knew that on December 13, bluebird bio stock started a 1-for-20 reverse stock split of its common stock. Every 20 shares of BLUE . . . This content is for paid subscribers. …

Broadcom Inc’s Greatest Day

Broadcom Inc Q4 Financial Results for Broadcom Inc (AVGO) reported financial results for its fourth quarter and fiscal year ended November 3, 2024, provided guidance for its first quarter of fiscal year 2025, and announced its quarterly dividend.  From Broadcom Hock Tan, President and CEO of Broadcom Inc. Said, "Broadcom's fiscal year 2024 revenue grew 44% year-over-year . . . This content is for paid subscribers. …

Novo Nordisk: European Regulatory Authority Adopts Positive Opinion for an Update of Ozempic® Label to Reflect Risk Reduction of Kidney Disease-Related Events

Novo Nordisk Bagsværd, Denmark, 12 December 2024 – Novo Nordisk (NVO) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial. The FLOW trial assessed the risk reduction . . . This content is for paid …

Johnson & Johnson Product CARVYKTI® Improves Standard of Care Therapies for Relapsed or Refractory Multiple Myeloma

Johnson & Johnson On December 9, 2024, Johnson & Johnson (JNJ) announced new results from the Phase 3 CARTITUDE-4 study demonstrating that a single infusion of CARVYKTI®  has significantly increased minimal residual disease (MRD) negativity rates in patients with relapsed or refractory multiple myeloma (RRMM) patients who were lenalidomide-refractory and had received one to three prior lines . . . This content is for paid subscribers. …

At ASH 2024, Gilead Sciences’ Kite’s Yescarta® Shows Its CAR T-Cell Therapy Uniquely Durable Response and Long-Term Survival After Five Years in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas

Gilead Sciences Kite Pharma, a Gilead Sciences Company (GILD) announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta ® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL), including follicular lymphoma (FL) or marginal zone . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

From ASH: Vertex Pharmaceuticals Presented Positive Durability Gene Editing CASGEVY for Severe Sickle Cell Disease and Transfusion-Dependent Beta-Thalassemia

Vertex Pharmaceuticals ASH Announcement Today, December 8, 2024, Vertex Pharmaceuticals (VRTX) announced longer-term data for CASGEVY™ (exagamglogene autotemcel) from global clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta-thalassemia (TDT). CASGEVY is the first and only approved CRISPR/Cas9 gene . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Intra-Cellular Therapies Submits Supplemental New Drug Application to the US FDA for CAPLYTA® Treatment of Major Depressive Disorder as Adjunctive Therapy

Intra-Cellular Therapies in the NEWS On December 3, 2024, Intra-Cellular Therapies (ITCI) announced the submission of the supplemental New Drug Application (sNDA) to the United States FDA to approve CAPLYTA as adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD) in adults. Intra-Cellular Therapies is . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Nuvig Therapeutics Announces $161 Million Series B Financing, Plus Its Progression to Phase 2 with Novel, Second-Generation Immunomodulator

Nuvig Therapeutics in the NEWS Nuvig Therapeutics – a privately held biotech company, developing novel immunomodulatory therapeutics for patients with inflammatory autoimmune diseases, announced the closing of a $161 million Series B financing. The financing was co-led by Sanofi Ventures, Blue Owl Healthcare Opportunities (formerly Cowen Healthcare Investments), and Norwest Venture Partners, with participation from new investors, B Capital, Leaps by Bayer, Global BioAccess Fund, LOTTE …

Gilead and Tubulis Enter Exclusive Option and License Agreement to Develop Antibody Drug Conjugate That Targets Solid Tumors

Gilead Sciences and Tubulis Agreement Gilead Sciences (GILD) and Tubulis announced that they entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target. Gilead will gain access to Tubulis’ proprietary Tubutecan and Alco5 platforms. The companies will collaborate to . . . This content is for paid subscribers. Please click here to subscribe or here to …

Why Keros Therapeutics is Getting $200 Million Upfront Payment and Possibly Future Payments from Takeda That Could Exceed $1.1 Billion and More

Keros Therapeutics in the NEWS Today, December 3, 2024, Keros Therapeutics (KROS) announced an exclusive global development and commercialization license agreement with Takeda (TAK) to advance elritercept. Elritercept is currently in two ongoing Phase 2 clinical trials: one in patients with very low-, low-, or intermediate-risk myelodysplastic syndrome (MDS) and one in patients with myelofibrosis (MF