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With 10 active or planned Phase 3 trials underway for Metsera’s berobenatide, Pfizer has signed a deal with Blackstone Life Sciences to finance the program to approval.
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BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
To grow into a biopharma juggernaut, China aims to become the leading source of innovative medicines on the global markets—a goal that experts say the country is on track to hit.
Policy uncertainty is hampering the growth of U.S. biotech as China rises thanks to carefully planned investment in the industry, experts said during a BioSpace webinar.
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Watching the baseball playoffs this week, I was struck by the parallels between the Los Angeles Dodgers and Eli Lilly. Both franchises spend a lot of money and always appear to come out on top.
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Neither Chongqing Qiancan Technology nor Tianjin Healthcare Medical Technology provided the records requested by the FDA, leading the agency to issue import alerts and warning letters.
Mean splicing correction for PepGen’s PGN-EDODM1 was 46.5% at week 13, compared to under 30% for competitors like Dyne Therapeutics, Novartis and Ionis Pharmaceuticals.
Awaiting a decision on Nov. 22 for its embattled Duchenne muscular dystrophy cell therapy deramiocel, Capricor has reduced its workforce by 10% and slowed programs not directly related to deramiocel, the biotech revealed in its third quarter earnings report.
Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant to support commercial production.
Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.
Last month, the FDA committed to designing a “fit-for-purpose” framework for regulating rare disease therapies based on patient need and realistically attainable evidence. With the upcoming decision for Capricor’s Duchenne muscular dystrophy cell therapy deramiocel, this paradigm faces its first key test.
The seven proposals in the Bio Advance plan include easing clinical trial starts, boosting manufacturing and establishing a new White House office to coordinate the government’s biotech policy.
Beam Therapeutics’ risto-cel provided at least 12 consecutive months of freedom from severe pain crises for patients with sickle cell disease in a mid-stage trial, setting the stage for an FDA application as early as this year.
Bayer’s Sunharbo has secured the first FDA approval of its class, establishing a regulatory pathway for other factor XIa inhibitors, such as Bristol Myers Squibb and Johnson and Johnson’s milvexian.
The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.