FDA approvals in just 60 days?

The FDA has launched the Commissioner's National Priority Voucher (CNPV) program, offering 1-2 month reviews, so drug developers can get faster market access for products that align with national priorities. Some examples could be:1. Strengthening US employment in development & manufacturing2. Ensuring that clinical trials have robust US patient population3. Affordability of drug products by … Continue reading FDA approvals in just 60 days?

Novartis acquires Regulus Therapeutics for $1.7B

Novartis (NYS) completed on 25 June the $1.7B acquisition of Regulus Therapeutics (RGLS), a clinical-stage biotech company that will strengthen Novartis' renal disease pipeline. Regulus Therapeutics was formed in 2007 through a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals with microRNA as the primary focus. Novartis announced its intent to acquire Regulus for $800M … Continue reading Novartis acquires Regulus Therapeutics for $1.7B

Biotech M&A – Three Trends to notice

Most biotech M&A coverage correctly highlights where capital is flowing, which therapeutic areas are hot, and which companies are poised to shape the future of medicine. For BD, corporate strategy, or investing, such information is useful. It gives context. It sets benchmarks. And it surfaces the big moves worth watching. But that's only part of … Continue reading Biotech M&A – Three Trends to notice