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Sourcing Blockbuster Oncology Products for Clinical Trial Supply

XTalks

Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Keytruda (Pembrolizumab) and Opdivo (Nivolumab).

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GSK’s Benlysta claims first FDA okay for lupus kidney damage

pharmaphorum

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

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FDA rejects Provention’s type 1 diabetes drug teplizumab

pharmaphorum

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

Drugs 98
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FDA sets August decision date for Provention’s type 1 diabetes drug

pharmaphorum

Now, the regulator has accepted the resubmission, kicking off another six-month review period as teplizumab has previously been awarded breakthrough status. Prior to the FDA rejection , GlobalData was predicting global peak sales of $691 million for teplizumab in 2027.

Drugs 52
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Provention finally gets FDA nod for type 1 diabetes drug teplizumab

pharmaphorum

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

Drugs 52
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Axsome faces delay for depression drug, hitting shares hard

pharmaphorum

On Axsome’s second-quarter results call, chief executive Herriot Tabuteau said that the FDA letter received on 30 July indicated that the problems with the filing “preclude discussion of labelling and post-marketing requirements,” adding that the company has been in communication with the regulator to try to learn more.

Drugs 52
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Therma Bright Acquires 100% Control of its COVID-19 Rapid Saliva Antigen Test and Announces Proposed Name Change for the Test

The Pharma Data

(TSXV: THRM) (“Therma Bright” or the “Company”), a progressive medical device technology company announces that it has taken 100% control of the research and development, regulatory, manufacturing and commercialization of its saliva-based rapid antigen test. The securities have not been registered under the U.S.

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