Moderna Inc.’s experimental vaccine is 94.5% effective in preventing Covid-19 based on interim data from a late-stage trial, the company said, becoming the second U.S. drugmaker to report results that far exceed expectations.

Moderna

Moderna Inc. will soon apply for real-time reviews of the experimental Covid-19 vaccine MRNA-1273 in Europe, the drug developer said, days after the EU health regulator launched rolling reviews of shots from the biotechnology company’s rivals.

Pfizer

The European health regulator is reviewing a Covid-19 vaccine being developed by Pfizer and BioNTech in real time, days after launching a similar assessment process for AstraZeneca’s vaccine.

CHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis — Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic […]

bluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.

San Diego-based Ligand Pharmaceuticals is acquiring San Diego-based Pfenex for a total deal transaction of up to $516 million.

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the expanded approval of Kyowa Kirin Co. Ltd.’s Crysvita (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphatemia.

The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending conditional marketing authorization of Novartis’ Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises, or pain crises, in patients with sickle cell disease aged 16 years and older.

The European Commission gave conditional approval for the use of remdesivir in severe COVID-19 patients following an accelerated review process, making the antiviral the region’s first authorized therapy to treat the virus.

Britain’s AstraZeneca clinched expanded regulatory backing for two medications, including one for the blockbuster cancer treatment Lynparza, in a development pipeline that now includes a possible coronavirus vaccine.