The Pharma Data

FDA GRANTS PRIORITY REVIEW TO AMGEN’S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company’s Biologics License Application (BLA) for tarlatamab. Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy…

Read MoreFDA GRANTS PRIORITY REVIEW TO AMGEN’S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER

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

Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). Treatment with all doses of VX-548 resulted in a statistically significant and…

Read MoreVertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy

Positive CHMP Opinion by EMA for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children

Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis…

Read MorePositive CHMP Opinion by EMA for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children

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)

CHMP Issues Positive Opinion for Biogen’s SKYCLARYS®, the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease

Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in people aged 16 years and older. If approved…

Read MoreCHMP Issues Positive Opinion for Biogen’s SKYCLARYS®, the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease

ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.

Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product…

Read MoreZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”)today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1…

Read MorePADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer