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Latest From Incyte Corporation
US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
Finance Watch: Fundraising Shows Preference For Later-Stage Companies
Recent financings, including the $150m launch of Pathalys and a planned $100m IPO for Mineralys, illustrate the reality of biopharma funding in 2023 – that having near-term clinical trial milestones are key to fundraising this year. Companies with dwindling cash are conserving the funds they have left.
Isofol And 4D - A Sorry Tale Of Two Battered Biotechs
The fear of going out of business before getting a drug submitted to regulators is one that a couple of European biotechs have had to face up to this week.
Sun Pharma Will Take Concert’s Alopecia Drug The Rest Of The Way
Coming up after Lilly’s Olumiant and Pfizer’s ritlecitinib in alopecia areata, deuterated ruxolitinib is said to offer a differentiated profile including patient-reported outcomes data.
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- Maxia Pharmaceuticals, Inc.
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