EuroBiotech Report—Novartis CAR-T, Shire-Roche, Zealand IPO, Erytech alliance and Enterome-Nestlé joint venture

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Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with Novartis, which breezed through an FDA advisory committee meeting to move its CAR-T cancer therapy to the cusp of approval. Novartis’ crosstown rival Roche had a less rosy week. Shire slapped the latter Swiss Big Pharma with a preliminary injunction over the allegedly “inaccurate and misleading” way it has talked up its hemophilia prospect emicizumab. Sanofi-partnered Zealand Pharma filed to raise $86 million in a Nasdaq IPO. Erytech Pharma struck another deal to advance its metabolic disease pipeline. Enterome spun off the diagnostic side of its business into a joint venture with Nestlé, freeing it to focus on therapeutics. And more. —Nick Taylor  

1. Novartis’ stellar CAR-T efficacy data power landmark cancer therapy towards approval

Novartis’ landmark CAR-T cancer therapy has won the unanimous support of the FDA’s advisory committee. The clean sweep followed a meeting in which CTL019’s stellar efficacy data outshone concerns about safety and manufacturing, setting Novartis up to win the first FDA CAR-T approval by Oct. 3.

2. Shire gets injunction against hemophilia rival Roche

Shire has obtained a preliminary injunction to stop Roche spreading “inaccurate and misleading” statements about clinical trial data. The legal tussle centers on Roche’s attempt to pin the blame for blood clotting in patients in its phase 3 emicizumab program on Shire’s bypassing agent Feiba.

3. Sanofi partner Zealand files for IPO to fund drug approvals

Zealand Pharma has become the latest European biotech to file for a Nasdaq IPO. The Sanofi-partnered peptide specialist is seeking about $86 million (€75 million) to take its treatments for insulin shock and short bowel syndrome (SBS) through clinical trials and up to registration.

4. Erytech pens academic pact to advance rare disease drug

Erytech Pharma has formed a collaboration with Canada’s Queen’s University to advance its drug against the rare metabolic disorder arginase-1 deficiency. The agreement enables Erytech to test its eryminase program in the inducible arginase-1 deficiency mouse model developed at Queen’s.

5. Nestlé, Enterome form microbiome diagnostic joint venture

Nestlé Health Science and Enterome have joined forces to create a microbiome-based diagnostics startup. The 50-50 joint venture starts life with $23 million from Nestlé, an inflammatory bowel disease test from Enterome that is nearing the market and a platform for finding biomarkers.

And more articles of note>>