After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.
PDUFA for NDA – First Review 26 September
A new opportunity is opening up in a rare subset of patients with acute leukemia – those with KMT2A rearrangements.
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The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.
All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.
The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.
But the French major is still keen on early-stage M&A.
Recent moves in the industry include changes at the top at Mitsubishi Tanabe Pharma and MC2 Therapeutics, plus MindMed acquires chief financial officer from Longboard Pharma.
In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.
IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?
