BioSpace

Your source for biopharma news and jobs

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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.

https://t.co/O9kWWVU1fh

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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.

https://t.co/jhZaKSi40U

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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 Q3 earnings report.

https://t.co/vNBDO7Kh0j

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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.

https://t.co/2zFR1QcOMR

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NextCure revealed “significant restructuring initiatives” in Q3 as it prepares for its planned merger with Avere Therapeutics. The changes included workforce cuts, ending facility leases and disposing of lab, manufacturing and facility-related assets.

https://t.co/VkoVzZzmH7

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Updated Today - BioSpace's IPO dashboard helps the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.

https://t.co/XWmFPJwlBh

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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.

https://t.co/kqKGIeYhgQ

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Novartis confirms nine patients treated with Zolgensma developed tumors; FDA orders GLP-1 label warnings about a rare eye condition tied to vision loss; and the FDA faces 11 therapy decisions this month, including Summit Therapeutics, Vertex and Capricor.

https://t.co/6j9fGKbjIr

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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.

https://t.co/yG2nIFfHi5

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Coherus is narrowing its pipeline projects while Gyre reorganizes after an acquisition, with both biotechs conducting workforce reductions.

https://t.co/ehPwcjzVEB

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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.

https://t.co/SpRPZH6QAE

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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.

https://t.co/XN08KvbYuW

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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 & Johnson’s milvexian.

https://t.co/w7Cbgs4Wr1

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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.

https://t.co/GAVt0bll7f

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Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.

https://t.co/TSJaqD7IcX

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The list honors 50 life sciences employers of choice. Marie Botin and Ali Kuhn from SERB Pharmaceuticals and Jarrat Jordan from CSL Behring share why their companies stand out.

https://t.co/g2rFhVagjO

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🏆 BioSpace is thrilled to announce the 2027 Best Places to Work in life sciences—our annual recognition of the companies setting the benchmark for excellence across the industry.

Explore the list of large and small employer winners here: https://t.co/z1SUIvWCL0

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Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.

https://t.co/nDPW1Biirk

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The Phase 3 results help clarify the safety profile of Zealand and Boehringer Ingelheim’s survodutide, but analysts do not think the drug will find utility beyond patients with liver-related risk factors.

https://t.co/a8uRkGx8aI

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If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.

https://t.co/dOmFx9hZ1p