Category News

Aetna Better Health® of Illinois and Mae Health announce partnership to give members access to local doulas for pregnancy and postpartum health support

Aetna Better Health® of Illinois announced a new partnership with digital health platform Mae Health (“Mae”) to support the maternal health needs of its underserved pregnant and postpartum members in Cook and Kane counties. Poor maternal health outcomes take an enormous physical and…

Read MoreAetna Better Health® of Illinois and Mae Health announce partnership to give members access to local doulas for pregnancy and postpartum health support

Vertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment…

Read MoreVertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Chugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer

 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it filed regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of an ALK inhibitor Alecensa® Capsules 150 mg (Hereafter Alecensa) for Postoperative adjuvant therapy for ALK fusion gene-positive…

Read MoreChugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Takeda (TSE:4502/NYSE:TAK) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance…

Read MoreTakeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

bluebird bio Details Plans for the Commercial Launch of LYFGENIA™ Gene Therapy for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “bluebird”) today announced the details of its U.S. commercial infrastructure to support timely, equitable access to LYFGENIA™ (lovotibeglogene autotemcel, also known as lovo-cel), an FDA-approved gene therapy for the treatment of…

Read Morebluebird bio Details Plans for the Commercial Launch of LYFGENIA™ Gene Therapy for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by…

Read MoreMerck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Roche’s Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment. A statistically significant…

Read MoreRoche’s Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment

Roche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or…

Read MoreRoche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients. Results reinforce the benefit seen…

Read MoreLatest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions