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The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.
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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
Seagen, Inc. and NovoCure Ltd. have each announced plans to open new facilities in the coming years, expanding local employment opportunities and respective presences in the biotech industry.
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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.
THE LATEST
Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.
The company’s blockbuster cancer asset Keytruda brought in more than $6.3 billion in the third quarter, a 17% increase from the same period last year, while bolstering its antibody-drug conjugate portfolio.
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
The company on Thursday said it now expects more than $10 billion in new product sales in 2026, despite previously forecasting $10 billion to $13 billion in 2025.
With recent high-profile failures, experts say safety concerns and a lack of diversification are hindering the field—but still hold out hope for an approval.
Attributing losses to exchange rate and pipeline impairment losses, the Japanese biopharma dropped its reported net profit forecast of 142 billion yen ($945.1 million) to 93 billion yen ($618.8 million).
A third-party audit found no integrity and reliability problems with data from BioXcel Therapeutics’ Phase III trial. The company intends to file a supplemental New Drug Application for its candidate BXCL501.
Subcutaneous injections of Eisai and Biogen’s Leqembi led to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remained.
Following the regulator’s denial of patisiran’s label expansion, Alnylam has published late-stage data for the RNAi therapeutic in The New England Journal of Medicine demonstrating its efficacy in ATTR-cardiomyopathy.
With the potential FDA approval of an MDMA-based therapy for PTSD on the horizon, biopharma stakeholders are eyeing psychedelics with fresh anticipation.