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Kangpu wraps up phase 1 clinical trial of CRL4-CRBN modulator KPG-818

Kangpu wraps up phase 1 clinical trial of CRL4-CRBN modulator KPG-818

Chinese pharma company Kangpu Biopharmaceuticals said that it has wrapped up the first-in-human phase 1 clinical trial of CRL4-CRBN modulator KPG-818 in the US. KPG-818 is being developed for the treatment of systemic lupus erythematosus (SLE) or hematological malignancies. The single ascending dose (SAD) randomized, double-blind, placebo-controlled study assessed the safety, tolerability, and pharmacokinetics of […]

Radioisotopes manufacturer SHINE Medical Technologies creates pharma unit

US radioisotopes manufacturer SHINE Medical Technologies has formed a new business division called SHINE Therapeutics in a move to boost its ability to focus on addressing critical future needs in the therapeutic isotope market. SHINE Therapeutics will focus initially on developing and commercializing lutetium‑177 or Lu‑177, which is a therapeutic isotope that is combined with […]

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Agilent acquires BioTek Instruments for $1.16bn

Agilent acquisition of BioTek : US-based lab instrument manufacturer Agilent Technologies has wrapped up its previously announced $1.16 billion acquisition of life science instrumentation manufacturer BioTek Instruments. The acquisition, which was announced in July 2019, is expected to boost Agilent’s position in the growing cell analysis segment. It was in 2015 when Agilent forayed into […]

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Alcon launches PanOptix trifocal intraocular lens for cataract patients in US

Alcon has commercially launched AcrySof IQ PanOptix trifocal intraocular lens (IOL) in the US after its approval by the US Food and Drug Administration (FDA). PanOptix is said to be the first trifocal lens to be approved by the FDA for patients undergoing cataract surgery in the US. The FDA approval was based on data […]

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Boehringer Ingelheim expands pets vaccines production facility in Athens

German pharma giant Boehringer Ingelheim has wrapped up the $76 million expansion of its pets vaccines production facility at Athens in Georgia, US. The investment doubles the capacity of Boehringer Ingelheim to produce vaccines for pets in the US and across the world two times. Expansion of the pets vaccines production plant was announced in […]

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Novartis bags Beovu FDA approval for wet AMD

Beovu FDA approval for wet AMD : Swiss pharma giant Novartis has been given approval from the US Food and Drug Administration (FDA) for Beovu (brolucizumab) injection for wet age-related macular degeneration (AMD). Also called RTH258, Beovu is now the first FDA approved anti-VEGF which is said to deliver greater fluid resolution compared to aflibercept. […]

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SHINE raises capital for medical isotope production facility from Oaktree

SHINE Medical Technologies has secured $50 million financing with funds managed by Oaktree Capital Management to support its upcoming medical isotope production facility and the commercialization of molybdenum-99 (Mo-99), lutetium-177 (Lu-177), and other diagnostic and therapeutic isotopes. Greg Piefer – founder and CEO of SHINE Medical Technologies said:  “Oaktree has broad expertise in complex infrastructure […]

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ProTom Radiance 330 proton therapy system bags FDA 510(k) Clearance

ProTom International has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiance 330 proton therapy system installed at the Massachusetts General Hospital (MGH) in Boston. According to the proton therapy technology manufacturer, the installed Radiance 330 proton therapy system is a compact, single-room system, which features an advanced pencil […]

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Verastem gets FDA orphan drug status for COPIKTRA for T-Cell lymphoma

Verastem Oncology has secured orphan drug designation for COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), from the US Food and Drug Administration (FDA) for the treatment of T-Cell lymphoma. COPIKTRA has FDA approval for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following more than two prior therapies. The PI3K also has […]

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CENTAUR clinical trial of AMX0035 : Amylyx says last patient completes last study visit

Amylyx Pharmaceuticals said that the last enrolled patient in the CENTAUR clinical trial, which is evaluating AMX0035 for amyotrophic lateral sclerosis (ALS), has finished the 24 weeks of study treatment. The CENTAUR clinical study is a randomized, double-blind, placebo-controlled phase 2 clinical trial. The primary goals of the mid-stage clinical trial are to assess the […]

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