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KFA-115 by Novartis for Melanoma: Likelihood of Approval

Pharmaceutical Technology

According to GlobalData, Phase I drugs for Melanoma have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

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AvKARE Recall: Erectile Dysfunction Drug and Antidepressant Mistakenly Packaged Together

XTalks

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

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KFA-115 by Novartis for Malignant Mesothelioma: Likelihood of Approval

Pharmaceutical Technology

According to GlobalData, Phase I drugs for Malignant Mesothelioma have a 77% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how KFA-115’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Iptacopan hydrochloride by Novartis for Paroxysmal Nocturnal Hemoglobinuria: Likelihood of Approval

Pharmaceutical Technology

According to GlobalData, Phase III drugs for Paroxysmal Nocturnal Hemoglobinuria have a 60% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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Iptacopan hydrochloride by Novartis for Glomerulonephritis: Likelihood of Approval

Pharmaceutical Technology

According to GlobalData, Phase III drugs for Glomerulonephritis have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Iptacopan hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Current and future players in the osteoarthritis market

Pharmaceutical Technology

The OA space is characterised by a high level of unmet clinical need driven by the limited effectiveness of currently available analgesics and the lack of disease-modifying OA drugs (DMOADs). There are no disease-modifying drugs currently approved for OA.

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