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REGENXBIO Announces Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

REGENXBIO Inc. announced the U.S. FDA granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal...

Chiesi Group focuses on biological drugs: an investment of 85 million euros for an international centre of excellence in Parma

Chiesi, the international research-focused pharmaceuticals and healthcare Group (Chiesi Group), presented today to the Italian Minister of Economic Development Giancarlo Giorgetti in Rome, the Biotech Center of Excellence Plant project, the new hub for the development of biological products....

ViiV Healthcare announces US FDA approval of Apretude, the first and only long-acting injectable option for HIV prevention

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, announced that the US Food and Drug Administration (FDA) approved Apretude, the first and only long-acting...

Sartorius and HOF Sonderanlagenbau Partnership Creates Streamlined Offering of Freeze-Thaw Solutions for Biological Products

Sartorius and HOF Sonderanlagenbau, announced a partnership today to integrate two HOF horizontal plate freeze-thaw units into Sartorius’ portfolio offering customers a full suite of compatible freeze-thaw equipment and consumables. This partnership will enable faster and easier implementation of...

Why there is no “one-size-fits-all” approach to bioavailability

In this article, Dr. Robert Lee, president, Lubrizol Life Science Health (LLS Health) – CDMO Division, explores why every drug development project is unique when it comes to enhancing bioavailability and discusses how companies can overcome bioavailability challenges and...

Moderna COVID-19 Vaccine Manufactured in Korea by Samsung Biologics Receives Marketing Authorization from MFDS

Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the Ministry of Food and Drug Safety of Korea (MFDS) has issued a marketing authorization for Spikevax®, Moderna's COVID-19 vaccine (mRNA-1273) manufactured by Samsung Biologics, a...

Recent Trends & Opportunities in Digital Therapeutics Industry: The Future of Healthcare

Digital therapeutics is a branch of digital health that is the amalgamation of innovative technologies, services, and products for healthcare and wellness. Digital therapeutics are used independently or in the combination with medical devices, therapies medications are optimized according...

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