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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

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Licensing regime posing challenge to micro and small medical devices industry: SMTA

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)

Licensing 189
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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 189
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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

In-Vitro 241
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Shionogi and MPP enter Covid-19 antiviral licensing deal

Pharmaceutical Technology

It will allow MPP to enable further manufacturing and supply of ensitrelvir following authorisation or approval from respective regulatory agencies. Under the deal, MPP granted sublicences to eligible generic manufacturers to produce and deliver ensitrelvir to 117 countries.

Licensing 147
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Experts advocate decriminalizing existing drugs act without compromising on drug quality and patient safety

AuroBlog - Aurous Healthcare Clinical Trials blog

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

Drugs 188
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Delhi HC grants 10 days’ time to Govt to file counter affidavit on petitions against ban of 14 FDCs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]