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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
74 Results
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FDA
FDA Greenlights Provention’s TZIELD as First Drug to Delay Advanced T1D
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
November 18, 2022
·
2 min read
·
Tristan Manalac
Policy
Iovance’s BLA for Advanced Melanoma Therapeutic Delayed Until Q1 2023
Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.
November 18, 2022
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2 min read
·
Mark Terry
Drug Development
Kidney Therapeutics to Halt CKD Progression Make Late-Stage Push Toward NDA
Therapeutics to halt the progression of chronic kidney disease are in Phase III trials, and others will enter that stage soon. NDAs could follow as early as 2024 with regulatory determinations in 2025.
November 18, 2022
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5 min read
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Gail Dutton
Drug Development
Pfizer-BioNTech, Moderna Tout New Data for Updated Omicron Boosters
Pfizer and BioNTech reported positive data Friday from their Omicron BA.4/BA.5-adapted bivalent booster. This followed a similar announcement by Moderna Monday.
November 18, 2022
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2 min read
·
Kate Goodwin and Heather McKenzie
Policy
Ex-Theranos CEO Elizabeth Holmes Convicted of Fraud, Sentenced to 11 Years
Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.
November 18, 2022
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2 min read
·
Alex Keown
Policy
Big Pharma Embraces Sustainability and Carbon Net Zero Goals
Large pharmaceutical companies are making plans to comply with sustainability and carbon net zero targets. Hear from AstraZeneca and Merck KGaA’s MilliporeSigma about their strategies.
November 18, 2022
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7 min read
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Gail Dutton
Genetown
Microbot Medical’s Novel LIBERTY® Robotic System Continues to be Validated with Latest U.S. Design Patent Allowance
Microbot Medical Inc., in a continuation of its efforts to create barriers and expand its global intellectual property portfolio for the LIBERTY® Robotic System, was issued a design patent allowance by the US Patent & Trademark Office, covering the LIBERTY Robotic System’s remote controller unique interface design.
November 18, 2022
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3 min read
BioMidwest
Prasco Launches Authorized Generic of ZIOPTAN® Ophthalmic Solution
Prasco Laboratories announced today the launch of the Authorized Generic of ZIOPTAN® (tafluprost ophthalmic solution) 0.0015%.
November 18, 2022
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2 min read
Pharm Country
Synaptogenix Announces $15 Million Private Placement with Existing Investors
Synaptogenix, Inc. announced that it has executed a securities purchase agreement to raise gross proceeds of approximately $15 million in a private placement financing of convertible redeemable preferred stock and warrants from existing investors.
November 18, 2022
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5 min read
Deals
IDEX Corporation Completes Acquisition of Muon Group
IDEX Corporation (NYSE:IEX) today announced that it has completed its previously-announced acquisition of micro-precision technology manufacturing company Muon B.V. and its subsidiaries (“Muon Group”).
November 18, 2022
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5 min read
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