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More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

Third Time Lucky? Sun’s Ampyra Generic Appears On Course To Indian Debut

Amid all the heat around the patents for Acorda Therapeutics’ multiple sclerosis therapy Ampyra (dalfampridine) in the US, Sun Pharma appears to have received a key approval for its generic version of the product in India setting the stage for a potential launch in the country.

Regulation Review Pathway

Mylan Suggests Downside To FDA's Efforts To Improve Generic Drug Review

Company says that while FDA has focused on expediting approval of third and fourth generics, it has not done so for first generics and complex products.

Generic Drugs Review Pathway

Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

Drug Review Profile Review Pathway

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Drug Review Profile Review Pathway

EU Firsts For CAR-T & PRIME As EMA Grants Kite Accelerated Assessment

Kite Pharma claims it has filed the first EU application to market a CAR T-cell therapy, and says that being on the European Medicines Agency’s PRIME scheme was helpful when it came to getting answers to the questions it had on the application.

Review Pathway Drug Review

AstraZeneca Hopes Imfinzi Breakthrough Get Can Burn Off MYSTIC Failure

Imfinzi becomes first cancer immunotherapy designated a breakthrough therapy for non-metastatic non-small cell lung cancer patients who have not progressed after platinum-based chemoradiation therapy, just days after announcing a missed primary endpoint in the first-line MYSTIC trial in metastatic NSCLC.

ImmunoOncology Research & Development

Boost For Brain Cancer As Tocagen Enters EMA’s PRIME

Brain tumors now equal lymphoma as the most common type of cancers being targeted by oncology products on the European Medicines Agency’s priority medicines (PRIME) scheme for getting medicines for unmet medical needs to patents faster.

Market Access Review Pathway

Commercial Capsules: Q2 Reporters, Mitsubishi Buy, Celltrion IPO, Renflexis Launch, Keytruda Fail, Ironwood and Vertex Trial Results

Q2 reporting is on a roll as GSK unveils a major shake-up under new CEO Walmsley; the prospect of a simplified route to approval may have helped Neuroderm secure Mitsubishi take-out; biosimilar developments include Celltrion Healthcare's IPO and Merck & Co's launch of Renflexis in the US; clinical trial updates were reported for Keytruda, Ironwood's GERD candidate and Vertex's next generation of cystic fibrosis candidates. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Commercial Biosimilars
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