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Mid-stage data for 4D Molecular Therapeutics’ wet AMD drug 4D-150 show improvements in visual acuity, reduced injection rate and encouraging safety data.
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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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Prometheus Biosciences, Inc. reported financial results for the quarter ended March 31, 2022 and highlighted recent corporate progress.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Carina Clingman, founder of The Collaboratory Career Hub, answers questions about the ins and outs of finding, landing and succeeding in openings in biotech.
The regulator has accepted Bristol Myers Squibb’s Opdivo and the chemotherapy cisplatin for priority review in patients with unresectable metastatic urothelial carcinoma, as well as Merck and Seagen’s first-line combo.
The study found only 19% of nearly 2,000 patients were still taking their prescribed anti-obesity medication at 12 months, compared to 40% that continued with Novo Nordisk’s Wegovy.
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more.
The Swiss pharma’s Fabhalta, a Factor B inhibitor, is the first FDA-approved oral monotherapy for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.
With the biopharma industry’s looming wave of gene therapy submissions and potential approvals, the senior senator is laying the groundwork for a legislative initiative to improve access to these expensive treatments.
In two late-stage trials, the experimental oral drug evobrutinib was unable to significantly reduce annualized relapse rates in MS patients compared with Sanofi’s Aubagio tablets.
A combination of Roche’s investigational treatment with Ibrance and fulvestrant met its primary endpoint of progression-free survival in the first-line setting in treating PIK3CA-mutated breast cancer.
In this third episode of Denatured’s series on AI in drug discovery, we discuss patient behavior and its influence on clinical trials and AI models with guests from GSK, IQVIA, Exelixis and DataHow.
ALTO-300 was significantly more effective in major depressive disorder patients with a specific EEG biomarker than in those without, according to results from an Alto Neuroscience Phase IIa study.