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Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience.
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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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GSK and Alector first partnered in 2021 to advance two antibodies for neurodegenerative diseases. Both assets have since failed to show significant clinical benefit.
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
After being bought by Bain for $3.3 billion, Tanabe has reached a deal to sell its manufacturing unit and 17 products.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.
Kalohexis is working on peptide therapies, including one for obesity that could offer an alternative approach to the GLP-1s that currently dominate the weight loss space.
In AstraZeneca’s third trip to Asia this year, the pharma secured ex-China rights to a dual inhibitor of PDE3 and PDE4, which in a Phase 2b study significantly improved lung function and lowered symptom burden in patients with chronic obstructive pulmonary disorder.
A surprising deal from Vertex Pharmaceuticals adds to Big Pharma’s acquisitive streak as Crinetics folds into the cystic fibrosis drugmaker. Meanwhile, IPOs and venture capital raises trend upward, but mostly for derisked companies. Plus, FDA decisions slow only slightly as the hunt for a permanent leader drags on.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.