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Gavel with whistle

SEC scores $17M win over investor fraud allegations

April 30, 2025
By Mark McCarty
The U.S. Securities and Exchange Commission said it obtained a judgment for a total of $17 million in penalties and disgorgement from a group of individuals and entities charged with investor fraud.
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Imvaay packaging

With FDA approval, J&J enters the myasthenia gravis fray

April 30, 2025
By Lee Landenberger
No Comments
The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
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Approved stamp

South Korea approves record number of biosimilars in 2024

April 30, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
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Exterior of NIH Vaccine Research Center

Senate hearing: US biomedical research at a crossroads

April 30, 2025
By Mari Serebrov
If the April 30 hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could face a big challenge if it tries to cut more than 40% of the NIH’s budget in fiscal 2026 as proposed and slap a 15% cap on indirect costs.
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Brain and DNA
Neurology/psychiatric

Unravel seeks Colombian approval to study RVL-001 for Rett and Pitt-Hopkins syndromes

April 30, 2025
Unravel Biosciences Inc. has submitted clinical study applications in Colombia seeking to begin proof-of-concept clinical trials for RVL-001 for Rett syndrome and Pitt-Hopkins syndrome.
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Arm wrapped with gauze

Abeona’s rare skin disease gene therapy approved by FDA

April 29, 2025
By Lee Landenberger
No Comments
Barely a year after the U.S. FDA shackled Abeona Therapeutics Inc.’s cell-based gene therapy with a complete response letter, the agency has approved it for treating a rare and genetic skin disease. Zevaskyn (prademagene zamikeracel), for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, will be priced in the U.S. at $3.1 million.
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CMS logo and website

CMS to hold advisory hearing for Parkinson’s devices​

April 29, 2025
By Mark McCarty
No Comments
The U.S. Centers for Medicare & Medicaid Services will hold an advisory meeting regarding devices for treatment of symptoms for Parkinson’s disease, but the agency indicated that it expects to see longer-term data for these treatments if manufacturers want Medicare coverage.
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IPO, coins, financial chart

China pharma migration: Hengrui greenlighted for Hong Kong IPO

April 29, 2025
By Marian (YoonJee) Chu
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
Read More
Conceptual image for brain cancer treatment

FDA issues CRL for Telix's glioma imaging agent, wants more data

April 29, 2025
By Tamra Sami
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
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Handshake with digital globe overlay

Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 29, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
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