Posts By: pharmanewsdaily

CMAB Biopharma, BJ Bioscience join forces for bi-functional antibody BJ-005

CMAB Biopharma (Suzhou), a pure-play biologics CDMO, and BJ Bioscience have signed an agreement for the development and manufacturing of a bi-functional antibody called BJ-005 as the first initiative in an exclusive collaboration. As per the terms of the agreement, CMAB will offer a complete range of CMC research and manufacturing services that address the […]

Galderma launches phase 3 atopic dermatitis trial for nemolizumab

Galderma, a Nestle-owned Swiss pharma company, said that it has enrolled the first patients in a phase 3 clinical study evaluating nemolizumab for the treatment of moderate-to-severe atopic dermatitis. The late-stage clinical trial will feature adult patients, who are randomly grouped in a double-blinded, placebo-controlled study that will assess the efficacy and safety of the […]

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 […]

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 […]

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 […]

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 […]

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 […]

FDA approves AstraZeneca’s FASENRA self-administration via FASENRA Pen

AstraZeneca has bagged approval from the US Food and Drug Administration (FDA) for the self-administration of FASENRA (benralizumab) through FASENRA Pen, a pre-filled, single-use auto-injector, for the add-on maintenance treatment of severe asthma in patients aged 12 years and older, and with an eosinophilic phenotype. FASENRA is a monoclonal antibody which directly binds to the […]

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