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centerforbiosimilars
1 小时
Unifying Standards: The Need for Streamlined Biosimilar Development
At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global ...
2 小时
Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST ...
Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in Fabry Disease With BLA Submission Expected in 2025 ...
infectiousdiseaseadvisor.com
3 小时
Single COVID-19 mRNA Vaccine Dose Supported for Patients With Preexisting Immunity
A single COVID-19 mRNA vaccine dose provided similar protection to that conferred by a 2-dose series among immunocompetent ...
Outsourcing-pharma
5 小时
PTC Therapeutics’ Translarna misses European regulatory hurdle again
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna ...
5 小时
Success of long-lasting HIV drug hinges on pricing
Affordability and mass distribution will be critical to the success of a long-lasting injectable HIV prevention drug that has ...
ALS News Today
6 小时
EMA’s CHMP upholds its negative opinion on masitinib for ALS
The opinion rejects granting conditional marketing authorization to AB Science’s masitinib as an oral add-on treatment for ALS in the EU.
Muscular Dystrophy News
6 小时
EMA agency continues to oppose renewing Translarna’s approval
CHMP upheld earlier opinions that Translarna is not of significant benefit to DMD due to nonsense mutations; European ...
7 小时
NanoViricides President Dr. Diwan to Present at the PODD Conference
NanoViricides, Inc. (NYSE Amer.: NNVC ) (the “Company”), a clinical stage global leader in broad-spectrum antiviral nanomedicines, today announces that Anil R. Diwan, Ph.D., the Company’s President ...
Le Lézard
8 小时
Health Canada Approves First and Only Oral Treatment for Brain Cancer
First major treatment advance in nearly 25 years; Gliomas target individuals in the prime of life, often in their 30s and 40s ...
8 小时
Nido Biosciences Announces Orphan Drug Designation for Lead Clinical Candidate to Treat ...
Nido Biosciences (Nido Bio), a clinical stage company developing precision medicines for debilitating neurological diseases, ...
The Korea Times on MSN
11 小时
Samsung Biologics wins record $1.24 bil. contract manufacturing deal
Samsung Biologics landed a $1.24 billion contract manufacturing deal with an Asian pharmaceutical giant, shattering its ...
pharmaphorum
11 小时
AZ, Ionis get CHMP backing for ATTR polyneuropathy drug
AstraZeneca and Ionis are set fair for EU approval of Wainzua, their treatment for polyneuropathy associated with ...
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