Posts

Armata Pharmaceuticals Provides Regulatory and Clinical Update Reflecting Sustained Progress Across Key Phage Therapeutic Development Programs

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Link to full article Nov. 18, 2021 Announces FDA clearance of IND to initiate Phase 1b/2a clinical trial of AP-SA02 in Staphylococcus aureus bacteremia (“diSArm” Study) Achieves significant milestone under previously announced therapeutic development award from the Cystic Fibrosis Foundation for continued advancement of Phase 1b/2a SWARM-P.a. clinical trial of AP-PA02 in Pseudomonas aeruginosa infections […]

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Cystic Fibrosis Foundation Makes Equity Investment in Armata Pharmaceuticals

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Link to full article Funds to be used to further advance development of lead candidate AP-PA02, which is being evaluated in a Phase 1b/2a clinical trial in Pseudomonas aeruginosa respiratory infections in CF patients Innoviva, a significant Armata shareholder, also elected to participate Oct. 28, 2021 In accordance with the terms of the investment agreement, […]

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$25m spur for vital bio-med projects

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Biomedical projects at the cutting edge of innovation will receive a $25m cash injection, in a boost for next-gen medicine including stem cell research, new treatments for autism and a technology that allows medicine to be taken through the skin. The $25m investment through the federal Biomedical Translation Fund will potentially benefit thousands of Australians […]

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CalciMedica Reports Topline Data from the AuxoraTM CARDEA Phase 2 COVID-19 Pneumonia Clinical Trial

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Link to full article Reduction in time to recovery through day 60 in patients with moderate and severe respiratory failure (primary endpoint analysis) Statistically significant reduction in time to recovery through day 60 in all patients who received study drug (a pre-specified supplementary analysis of the primary endpoint) Statistically significant 56% relative risk reduction in […]

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CalciMedica Announces Publication of Preclinical Data in Journal of Immunology Further Validating Calcium Release-Activated Calcium (CRAC) Channels as Drug Targets for Diseases of the Airways

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Link to full article Data provides further evidence of the broad potential for CRAC channel inhibitors to benefit patients across multiple disease areas involving the lungs LA JOLLA, Calif., September 9, 2021 – CalciMedica Inc. (“CalciMedica” or the “Company”), the CRAC channel company, today announced the publication of preclinical data validating calcium release-activated calcium (CRAC) channels, P2Y2 […]

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Armata Pharmaceuticals Announces Second Quarter Results and Provides General Corporate Update

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Link to Full Article Continues to advance AP-PA02 through Phase 1b/2a clinical trial as a potential treatment for cystic fibrosis patients with chronic Pseudomonas aeruginosa Announced that Todd R. Patrick, CEO, has retired from the Company. Brian Varnum, PhD, former President and Chief Development Officer, has been appointed the Company’s new CEO MARINA DEL REY, […]

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Acrux receives FDA approval for its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream

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Melbourne, Australia; 28 July 2021: Acrux Limited (ASX:ACR) (‘Acrux’ or the ‘Company’) is pleased to announce that the US Food and Drug Administration (‘FDA’) has approved its generic version of EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream. In June 2019, Acrux submitted an ANDA to seek approval from the FDA to market its generic version […]

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Acrux receives approval from the FDA for its generic version of Jublia®

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Melbourne, Australia; 22 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce that the US Food and Drug Administration (FDA) has granted approval of the Company’s generic version of Jublia® (efinaconazole) topical solution, 10%. Key Points  FDA’s approval of the application represents an important milestone for Acrux, being its second approval […]

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Acrux confirms patent challenge for generic version of Aczone®

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Melbourne, Australia; 8 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) today announced that Almirall LLC has initiated patent litigation against Acrux in the U.S. District Court for the District of New Jersey, regarding the Company’s Paragraph IV Abbreviated New Drug Application (ANDA) for Dapsone Gel 7.5% (a generic version of Aczone® Gel, 7.5%), […]

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Acrux Announces Board Appointment

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Melbourne, Australia; 4 June 2021: Acrux Limited (ASX:ACR, “Acrux” or the “Company”) is pleased to announce Mr Don Brumley has joined the Board as a Non-executive Director. Mr Brumley has 30 years’ experience as a senior partner of Ernst & Young, Oceania. He has extensive experience in IPOs, transactions and audit. Mr Brumley has advised […]

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