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FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Combination with Gazyva for Previously Untreated Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or …

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FDA Grants Immusoft’s Investigational MPS I Treatment Rare Pediatric Disease Designation

SEATTLE–(BUSINESS WIRE)–Immusoft Corporation, a Seattle-Wash.-based cell therapy company, announced today that the U.S. Food and Drug Administration (FDA) has granted it Rare Pediatric Disease Designation (RPDD) for Iduronicrin genleukocel-T, Immusoft’s Sleeping Beauty transposon-engineered autologous plasmablasts for the expression and delivery of alpha-L-iduronidase (IDUA) to treat Mucopolysaccharidosis type I (MPS I). …

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FDA Grants Orphan Drug Designation to Lynparza for Treatment of Pancreatic Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for LYNPARZA for the treatment of pancreatic cancer. LYNPARZA is currently being investigated as maintenance therapy in patients with germline BRCA-mutated …

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Gottlieb Makes Statement on FDA’s New Steps to Modernize Drug Development, Improve Efficiency and Promote Innovation of Targeted Therapies

The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a …

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Alnylam to Initiate Rolling Submission of NDA and Pursue Full Approval for Givosiran for Acute Hepatic Porphyria

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company plans to pursue a full approval based on the complete results of the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting …

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Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin®(trastuzumab) …

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FDA Grants Breakthrough Therapy Designation to Loxo Oncology’s Investigational LOXO-292 for RET Fusion-Positive Thyroid Cancer

STAMFORD, Conn., Oct. 15, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid …

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FDA Grants Orphan Drug Designation to Synspira’s Investigational Cystic Fibrosis Therapy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synspira, a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, today announced that it has been granted Orphan Designation by the United States Food and Drug Administration (FDA) for poly (acetyl, arginyl) glucosamine (PAAG15A), for the treatment of cystic …

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FDA Approves Stiolto Respimat sNDA to Add on COPD Exacerbation Reduction

RIDGEFIELD, Conn., Oct. 11, 2018 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in …

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FDA Lifts Clinical Hold on Vertex/CRISPR Therapeutics’ Investigational Gene Therapy CTX001 for the Treatment of Sickle Cell Disease

ZUG, Switzerland and BOSTON and CAMBRIDGE, Mass., Oct. 10, 2018 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and accepted the Investigational New Drug application (IND) for CTX001 for the treatment of …

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