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Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

AuroBlog - Aurous Healthcare Clinical Trials blog

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Licensing 149
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Juvisé licenses J&J’s MS drug Ponvory for marketing outside North America

Pharmaceutical Technology

The market for multiple sclerosis therapies is expected to be worth over $41bn by 2030, according to GlobalData.

Marketing 130
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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Pharmaceutical Technology

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1). The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA).

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Searchlight licenses Mithra’s menopause drug Donesta for Canadian market

Pharmaceutical Technology

Mithra Pharmaceuticals is in line to receive €17.05m ($18.8m) in licencing fees, and milestone-based payments.

Licensing 130
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Current and future players in the lupus market

Pharmaceutical Technology

As such, the SLE and LN marketplace is dominated by generics, and GSK’s Benlysta and AstraZeneca’s Saphnelo are the only drugs that have gained marketing approval specifically for SLE in more than 50 years. In previous years, Benlysta has managed to grow the lupus market in terms of value, having generated approximately $492.9m

Marketing 278
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TG shares tumble following licensing deal for MS drug

Bio Pharma Dive

Some on Wall Street believe the New York-based biotechnology company is now less likely to get acquired after agreeing to sell partial rights to its only marketed product.

Licensing 130
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Bio-Thera and Biomm enter licensing deal for ustekinumab biosimilar

Pharmaceutical Technology

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.

Licensing 130