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Year: 2021

NOBLE Study Brings Advanced Prostate Imaging to Rural Australia – First Patient Dosed

MELBOURNE, Australia, Nov. 15, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first Australian patient has been dosed in the international NOBLE Registry, a global study that aims to improve access for men to state-of-the-art prostate cancer imaging tools. The NOBLE Registry is co-supported by Telix and Brussels-based Oncidium Foundation. The NOBLE (Nobody Left Behind) Registry is collecting clinical data to inform the development of TLX599-CDx (99mTc-iPSMA), an investigational prostate cancer imaging agent that targets PSMA (prostate specific membrane antigen) using single photon emission computed tomography (SPECT). The Australian arm of the NOBLE study is being led by PhD researcher Peter Tually at TeleMed in collaboration with Clinical Professor Nat Lenzo, and Professor...

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Production report for October 2021

Oslo, 14 November 2021 Below please find average gross operated production in October 2021 and corresponding numbers for September 2021.IOX operated         October 2021 September 2021  Boepd(1) Bopd (2) Boepd(1) Bopd (2)Colombia 782 556 747 507Argentina (3) 2,114 382 2,247 431(1)   Barrels of oil equivalents per day(2)   Barrels of oil per day(3)   Operated by Selva Maria Oil on behalf of IOX until local authorities approve operator’s licence. Comments In October, average daily production was 2,896 barrels of oil equivalents per day (boepd), compared to 2,994 boepd in September for Argentina and Colombia combined. The slight decrease in production is mainly due to certain temporary operational issues that are further explained below. In Argentina, a combination of operational commercial issues in the Campo Molino field...

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Lexicon’s Sotagliflozin Demonstrates Benefits in Heart Failure and Blood Glucose Control Across the Full Range of Kidney Function in New Analysis of Clinical Data

Post hoc analysis of pooled clinical data from the SOLOIST and SCORED trials supporting benefit of sotagliflozin presented at the virtual American Heart Association Scientific Sessions 2021, including:Sotaglifozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function studied. Sotaglifozin also significantly reduced hemoglobin A1c, a goal of diabetes management, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease.THE WOODLANDS, Texas, Nov. 14, 2021 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that a new analysis evaluating the clinical benefit of Lexicon’s investigational drug, sotagliflozin, in heart failure and blood...

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Frontier Airlines Orders 91 Additional A321neo Aircraft, Tripling Size by 2029

Cements Position as America’s Greenest Airline with New A321s Achieving 119MPG Per SeatFrontier Airlines Fleet Plan Chart Nov. 2021Frontier Airlines Future Fleet Plan Chart as of Nov. 2021DENVER, Nov. 14, 2021 (GLOBE NEWSWIRE) — Frontier Airlines (NASDAQ: ULCC) today announced a major fleet expansion with an order for 91 additional A321neo aircraft from leading aircraft manufacturer Airbus as part of a larger joint aircraft order across the Indigo Partners portfolio. “These additional A321neo aircraft will enable us to triple the size of the airline by 2029,” said Barry Biffle, president and CEO, Frontier Airlines. “We are already America’s Greenest Airline with an existing fleet that is 43 percent more fuel efficient, on average per seat, than other U.S. carriers. The A321neo is expected to deliver nearly 120...

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Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification*

November 14, 2021 Amsterdam, the Netherlands – On June 14, 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the US and several other markets is under way. As expected, the US Food and Drug Administration (FDA) recently conducted an inspection of a Philips Respironics manufacturing facility in connection with the recall. On November 12, 2021, the FDA published a list of the observations it provided to Philips Respironics. In accordance with normal practice, Philips Respironics...

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Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Combination with Pembrolizumab in Advanced Cancers at Society for Immunotherapy of Cancer (SITC) Annual Meeting

Tumor Infiltrating Lymphocyte (TIL) Cell Therapy in Combination with Pembrolizumab in Immune-Checkpoint Inhibitor Naïve Patients Shows Overall Response Rate (ORR) of 57% in Cervical Cancer, 60% in Melanoma with 30% Complete Response (CR) and 39% in Head and Neck Cancer SITC Update Conference Call and Webcast on Saturday, November 13 at 5:30 pm ET SAN CARLOS, Calif. and WASHINGTON, Nov. 13, 2021 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. A slide presentation is also available on the Iovance website. Clinical data...

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Video Release — Virginia-Class Attack Submarine New Jersey (SSN 796) Christened at Newport News Shipbuilding

NEWPORT NEWS, Va., Nov. 13, 2021 (GLOBE NEWSWIRE) — Huntington Ingalls Industries (NYSE: HII) today christened pre-commissioning unit New Jersey (SSN 796) at the company’s Newport News Shipbuilding division. “The christening is a Navy and shipbuilder tradition that celebrates the hard work and dedication of the women and men who are building this magnificent submarine, readying her for the next phase of construction, which includes launch, testing, sea trials and delivery to the Navy,” said Jennifer Boykin, president of Newport News Shipbuilding. “We commemorate these American builders during a challenging time in our nation’s history.” “When New Jersey joins the Navy’s fleet, she will deliver firepower for freedom, taking with her the skill of her shipbuilders, the spirit of her sponsor, the courage of her commander and crew and...

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NextCure and Collaborators Provide Clinical and Research Updates on NC318 and NC410 Candidates at Society for Immunotherapy of Cancer Annual Meeting

BELTSVILLE, Md., Nov. 13, 2021 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced new data from two clinical studies and one research study presented at the Society for Immunotherapy of Cancer (SITC) annual meeting in Washington, D.C., and on a virtual platform. The data come from clinical studies evaluating NC318, a Siglec-15 (S15) antibody, and NC410, a fusion protein of LAIR-2, in patients with advanced/metastatic solid tumors, as well as from a research study evaluating NC410’s impact on T cell activation and myeloid cell polarization conducted in collaboration with the National Cancer Institute at the National Institutes of Health. “We are...

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Aadi Bioscience Presents Two Abstracts on FYARRO (nab-Sirolimus) at the Annual Meeting of the Connective Tissue Oncology Society (CTOS)

In an Expanded Access Program, advanced malignant PEComa patients who previously progressed on other mTOR inhibitors showed a 25% partial response rate and 63% clinical benefit rate when treated with nab-sirolimus In a final analysis from the AMPECT registrational trial in mTOR naïve patients with advanced malignant PEComa, results of a 2.5 year-follow-up showed a median duration of response exceeding 36 months and conversion of 2 patients to complete responses FYARRO™ has a November 26, 2021 PDUFA target dateLOS ANGELES, Nov. 13, 2021 (GLOBE NEWSWIRE) — Aadi Bioscience, Inc. (“Aadi”) (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced two oral presentations that were made related to its lead candidate,...

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Outlook Therapeutics Presents NORSE TWO Phase 3 Pivotal Safety and Efficacy Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at the Retina Subspecialty Day, American Academy of Ophthalmology (AAO) 2021 Annual Conference

– NORSE TWO showed highly statistically significant, clinically relevant results consistent with historical ophthalmic bevacizumab data – Data support planned BLA submission with U.S. FDA in Q12022 ISELIN, N.J., Nov. 13, 2021 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today presented pivotal safety and efficacy data from the Phase 3 NORSE TWO trial for ONS-5010, an investigational ophthalmic formulation of bevacizumab for use in wet age-related macular degeneration (wet AMD) and other retinal indications, at the Retinal Subspecialty Day, AAO 2021 Annual Conference. The data presentation “Safety and Efficacy Results of ONS-5010, as Ophthalmic Bevacizumab,...

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