Remove opinion letters
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Court Rules FDA Must Divulge Internal Deliberations on Vanda’s Hetlioz sNDA

Pharma Leaders

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

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FDA Considers Biomarker Data Supportive of Tofersen Approval

Pharma Leaders

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

FDA 52
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CDER Flags Enforcement Successes for Fiscal 2022

Pharma Leaders

Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you. Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

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MHRA releases its CTA application performance metrics

European Pharmaceutical Review

Initial clinical trial authorisation applications were divided into ‘first review’ (time from receipt of valid application to initial opinion letter) and ‘second review’ (the time from receipt of rounds for non-acceptance (GNA) response to final opinion).

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FDA rejects Lilly’s BLA for UC drug over manufacturing concerns

Pharmaceutical Technology

The regulator has issued a complete response letter. Mirikizumab also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. This opinion is intended for use of the drug as a first-in-class treatment for adults with moderately to severely active UC.

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FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

Pharmaceutical Technology

early treatment diabetic retinopathy study (ETDRS) letters, in comparison to its reference, Lucentis, which had an improvement of 5.6 ETDRS letters. Despite Cimerli’s approval, KOL opinions on biosimilars remain impartial. Thus, the biosimilar presented a similar efficacy to the reference product.

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FDA pushes back on approving mirikizumab due to manufacturing issues

Pharmaceutical Technology

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.