Europe’s medicines regulator says it is working more closely than ever with biopharma companies because of the COVID-19 pandemic, and using fast-track methods such as rolling submissions to speed approvals for drug treatments of the novel virus.
Coronavirus Update: EU Regulator Skeptical On Vaccine This Year, Takeda Prepares Hyperimmune Alliance
Plus: Fujitsu Pledges Open IP, Zydus Cadila Secure Testing Kit Manufacturing
EMA leader doesn't share Oxford's optimism, Takeda-led alliance forges ahead with plasma-derived therapy plans, Indian pharma firm Cadila gets into testing kits.

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Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.
A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.
Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.
Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.
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BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.
It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.