News
Kazia Therapeutics is eyeing an FDA accelerated approval pathway for its investigational glioblastoma drug paxalisib, with Wednesday’s release of secondary overall survival data from a Phase II/III trial.
FEATURED STORIES
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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Job Trends
ImmunoGen, which is developing Antibody-drug conjugates (ADCs) for the treatment of cancer, is on a hiring spree. The company is looking to hire for more than 200 positions by the end of 2022.
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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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The United States’ relatively high costs have become a political issue on both sides of the aisle. Here’s how international pharmaceutical prices stack up.
The Dutch biotech’s stock dropped about 10% Tuesday morning after the company reported that its injectable Vyvgart Hytrulo missed the primary and secondary endpoints in an immune thrombocytopenia study.
Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.
The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
While XEN1101 failed to hit the primary endpoint in a Phase II trial, the Canadian company is “actively exploring” further development of the program based on the totality of the data.
Pegozafermin showed statistically significant improvements in treating patients with nonalcoholic steatohepatitis, notching a win in the race to get the first treatment to market for the condition.
New data show the biologic significantly reduced exacerbations in chronic obstructive pulmonary disease, confirming positive results from an earlier trial.
A year after exiting the U.S. market, GSK is setting the stage for the antibody-drug conjugate’s possible return in relapsed/refractory multiple myeloma.