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Public Company Edition: It took 256 days for 2021 to surpass the 2020 record of 86 biopharma initial public offerings in the US in one year. Also, Procaps raised $115m ahead of its SPAC merger and aTyr and bluebird raised $75m each.
Regeneron's Eylea and Roche's Lucentis currently dominate the treatment market for wet-AMD and diabetic eye disease, but biosimilar ranibizumab and new brand launches are on the horizon.
In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.
Amgen’s KRAS G12C inhibitor in combination with the company’s Vectibix generated a 27% overall response rate, nearly tripling the responses seen with Lumakras monotherapy in colorectal cancer.
AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.
The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.
France’s Provepharm Life Solutions, which finds new uses for known mature molecules, in particular antidotes and surgical dyes, by improving their efficacy and maximizing their therapeutic potential, has fresh funds to expand its portfolio.
With big oncology losses largely in the rearview mirror, Roche is trying to sell investors on its next wave of cancer drugs; R&D overview pushes message of pipeline renewal.
The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.
Management updated investors on M&A strategy, US drug pricing reform and R&D investment.
After discussions with the US FDA, the company determined it can file AMX0035 based on Phase II/III results and interim Phase III data. Amylyx is sticking with its go-it-alone strategy for global commercialization.
Private Company Edition: Recent biopharma venture capital financings add up to $1.7bn, including a $135m crossover round for HilleVax after spinning out of Takeda in July to advance a norovirus vaccine, Skyhawk’s $133m in fresh funding and Obsidian’s $115m series B round.
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