Posts By: pharmanewsdaily

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Janssen bags Stelara FDA approval for ulcerative colitis treatment

Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged approval from the US Food and Drug Administration (FDA) for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis. Considered to be a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, […]

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Alexion Pharmaceuticals bags Ultomiris FDA approval for atypical HUS

Ultomiris FDA approval : Alexion Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for Ultomiris (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) in adults and pediatric (one month of age and older) patients. The approval is for the prevention of complement-mediated thrombotic microangiopathy (TMA) in such patient populations. […]

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Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne

AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for AMZEEQ (minocycline) topical foam, 4% for the treatment of moderate to severe acne. Previously known as FMX101, AMZEEQ has been indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne […]

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Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients

Xarelto FDA approval : The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) for the prevention of venous thromboembolism or blood clots in acutely ill medical patients. The latest approval for the drug is for the treatment of blood clots in hospitalized […]

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Alexion to acquire Achillion to strengthen rare diseases portfolio

Alexion acquisition of Achillion : Alexion Pharmaceuticals has agreed to acquire rival US pharma company Achillion Pharmaceuticals for about $930 million in an all-cash deal as per the latest pharma acquisition news. Achillion is a clinical-stage biopharma company, which is engaged in developing oral small molecule Factor D inhibitors for the treatment of people with […]

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Denovo Biopharma gets FDA approval to launch phase 2b GBM trial for DB102

Denovo Biopharma has secured approval from the US Food and Drug Administration (FDA) to launch its phase 2b clinical trial of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation and temozolomide. The GBM clinical study is an extension of the company’s work to identify a genetically-enriched patient population with diffuse large B-cell […]

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DAZZLE clinical trial : Kodiak Sciences doses first patients with KSI-301 in phase 3 wet AMD trial

Kodiak Sciences said that it has treated the first patients in the phase 2 DAZZLE clinical trial of KSI-301, its investigational intravitreal anti-VEGF antibody biopolymer conjugate, in wet age-related macular degeneration (wet AMD). The DAZZLE trial (also called KSI-CL-102) is designed to assess the safety and efficacy of KSI-301 in AMD patients who are treatment-naïve. […]

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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 […]

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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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