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Benefits of Drug Patent Licensing Agreements

Drug Patent Watch

The Power of Patent Licensing: Unlocking Innovation and Access to Medicines Patent licensing agreements have become a crucial tool in the pharmaceutical industry, allowing companies to collaborate and…

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What you should know about the FDA’s Biological License Application Process

Reprocell

The biological license application (BLA) is one of the many requests for marketing approval received by the FDA. Unlike the New Drug Application (NDA) which is usually the go-to submission for chemically synthesized, low molecular weight drugs BLAs grant sponsors the ability to introduce Biologics into interstate commerce.

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Investors put $400M into biotech licensing obesity drugs from China

BioPharma Drive: Drug Pricing

The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.

Licensing 142
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Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

BioPharma Drive: Drug Pricing

Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

Licensing 133
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PTC rebuffed again by EMA; Novartis licenses China-based biotech’s cancer drug

BioPharma Drive: Drug Pricing

European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data and Leqembi hit a roadblock in Australia.

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Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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Gilead agrees to license new HIV drug in low-income countries

BioPharma Drive: Drug Pricing

The company will permit six generic drugmakers to make and sell lenacapavir in 120 countries that have high incidence of the disease but limited resources.