Drug Research

Sai Life Sciences Opens High-Potency API Manufacturing Facility

Sai Life Sciences, one of India's fastest growing contract research, development and manufacturing organizations (CRO-CDMO), has opened a new high-potency API (HPAPI) manufacturing facility at its cGMP API manufacturing campus in Bidar, India. The addition of this new facility...

Charles River and Rznomics Announce RNA-based Anticancer Gene Therapy Manufacturing Alliance

Charles River Laboratories International, Inc. and Rznomics Inc., a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, announced a viral vector contract development and manufacturing organization (CDMO) partnership. Rznomics will leverage Charles River’s viral vector...

Forge Biologics Receives PRIME Designation from EMA for Novel Gene Therapy

Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), said that the European Medicines Agency (EMA) has granted priority medicines (PRIME) designation to FBX-101, Forge’s lead adeno-associated virus (AAV) drug candidate and novel gene therapy for treating...

Microbiome Industry Explores Hong Kong As APAC Region Centre

To host the Microbiome Summit 2023 at the Hong Kong Science Park, the medicine faculty of the Chinese University of Hong Kong, Hong Kong Science and Technology Parks Corporation and Microbiota I-Center joined hands recently. More than 20 eminent...

Price Negotiations For 10 US Prescription Drugs To Be Shared

A senior Biden White House official said on January 11 that the U.S. administration will provide a list of the ten prescription pharmaceuticals for which it intends to negotiate prices on September 1 and the costs a year later. The...

Antibiotics Shortage Challenge- A Growing Concern For Europe

According to Stella Kyriakides, the EU Health Commissioner, the thought about changes to EU pharmaceutical law shall have robust obligations for medicine supply and also earlier shortage notifications. She was speaking at the European Parliament session, where she opined that...

FDA Wraps Up The REMS Standards For Prescription Medicines

The FDA's Final Guidance on REMS programmes for prescription medications, has just been published. The document is officially titled Format and Content of a REMS Document: Guidance for Industry. The FDA may demand a risk management strategy known as REMS,...

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