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Product Reviews & Approvals

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Approvals

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Latest From Approvals

European CHMP Opinions And MAA Updates

A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Approvals Performance Tracker

Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.

Europe Regulation

FDA's NDA And BLA Approvals: Zilretta, Lyrica CR

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Row Erupts Over “Third Way” For Biosimilar Approvals In Colombia

Colombia’s health ministry has accused the R&D-based pharmaceutical industry association of prioritizing monopolies over patients after its attempts to suspend legislation that promises a faster route to market for biosimilars.

Colombia BioPharmaceutical

CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

Europe Approvals

Ocrevus Tries Again For EU Approval Nod

Just three initial marketing authorization applications are up for an opinion this week on whether they should be approved for sale across the EU. Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), is one, after failing to secure a positive opinion earlier. The October meeting of the panel that will decide, the European Medicines Agency’s CHMP, is under way in London.

Europe Regulation
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Drug Reviews

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Latest From Drug Review

A Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.

Advisory Committees Drug Review

FDA Outlines How Generic Drug Makers Can Reverse Filing Decisions

ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.

Generic Drugs Manufacturing

US Filing For AZ’s Imfinzi In Stage III Lung Cancer

Important US filing goes ahead as AstraZeneca submits sBLA for Imfinzi in earlier-stage non-small cell lung cancer.

United States Drug Review

Novo's Semaglutide: Retinopathy Events Will Draw US FDA Panel's Focus

Once-weekly GLP-1 agonist was associated with higher risk of diabetic retinopathy complications in the SUSTAIN-6 trial, but Novo says this is consistent with data on early worsening of pre-existing retinopathy after glycemic control improves. While FDA's ophthalmology consultant concludes there's no cause for worry, clinical review team expresses 'residual concerns.'

Advisory Committees Drug Review

Pharma Fees To Soar In Canada Under Government Proposals

The licence evaluation fee Health Canada charges for drugs containing new active substances could jump by 76% under proposals by the government department, which says its current fees for pharma and medtech are outdated and need to change.

Drug Review Regulation
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