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Contract development and manufacturing organizations looking to do business with biopharmas include Lonza, which has more than 30 sites, and Samsung Biologics, which recently announced a planned acquisition of another CDMO.
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Zanvastro, an antisense oligonucleotide therapy, represents the first independent neurology launch for Ionis Pharmaceuticals, which intends to leverage the foothold for more approvals in rare neurodegenerative diseases, including Angelman syndrome.
Last month’s FDA advisory committee meetings for therapies developed by Capricor Therapeutics and Replimune effectively illustrate the different outcomes for patients when the agency prioritizes specialization in its reviews.
Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.
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The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
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AbbVie’s etentamig has a relatively cleaner safety profile and an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets.
The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
A new program from ARPA-H has devoted funding to make individualized RNA-based genetic medicine more efficient to produce and improve accessibility.
New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.
For $110 million upfront, GSK will have the exclusive global right to advance HMPL-A830, which combines an EGFR-targeting antibody with a small-molecule KRAS blocker. The asset will be studied for colorectal, pancreatic and lung cancer.
The success of apazunersen in a Phase 3 trial for Angelman syndrome was a key driver of Ultragenyx’s value, according to William Blair, and the asset’s failure robs the biotech of any meaningful near-term milestones.
The FDA’s primary review team found that Replimune hadn’t sufficiently addressed deficiencies that had been pointed out in the two prior rejection letters for the melanoma therapy Tudriqev.
In this episode of Denatured, you’ll hear from Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We explore why the Benelux region remains scientifically strong, but investment fragmented, and what it will take to turn it into a more unified biotech investment corridor.
Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.
The biologics license application follows months of public speculation—and regulatory reversals—for uniQure’s AMT-130. If accepted by the FDA for priority review, approval could come in the second quarter of 2027.