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WuXi Biologics, VISEN Partner to Make Lonapegsomatropin in Chengdu

The Pharma Data

A Game-Changing Growth Hormone Therapy Lonapegsomatropin is a long-acting recombinant human growth hormone (rhGH) therapy designed to be administered once weekly. Localized commercial production is anticipated to begin by 2028, following the completion of the technology transfer and necessary scale-up processes.

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Gilead Advances in HIV Market With Twice-Yearly Yeztugo, Leaving GSK Behind

The Pharma Data

Gilead’s HIV Business: Already a Powerhouse Gilead has long been a dominant player in the HIV treatment and prevention market. billion—coming from Biktarvy, a once-daily triple-combination therapy for people living with HIV. Descovy, another key product used for both treatment and PrEP, added $2.1

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The Competitive Edge of Biosimilars

DrugBank

This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles. billion by 2028. One key challenge is the development of biosimilars for complex biologics, such as monoclonal antibodies used in cancer treatment and gene therapies.

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Inside The Altascientist Issue 33: CNS Drug Development – Integrated Solutions Lessen Complexity

Alta Sciences

Listen or read Issue 33 of The Altascientist on altasciences.com , or wherever you listen to podcasts: GROWING NEEDS FOR CNS THERAPY SOLUTIONS The different parts of the nervous system, including the brain and spinal cord and the peripheral nervous system, are important drug targets for many serious diseases affecting human health.

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Almirall demonstrates resilient performance year to date despite COVID-19 impacts

The Pharma Data

R&D pipeline continues to drive future value through innovation and differentiated therapies including expected upcoming approval of Tirbanibulin. All Almirall’s production sites continue to operate at full capacity in order to be able to ensure the supply of medicines to all patients requiring treatment.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

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Article EMA Thank You British regulators tease new device regulations in informative live session

Agency IQ

government recently extended that recognition through 2028 for medical devices and 2030 for IVDs. Certain IVDs will be treated differently; companion diagnostics used with drug therapies would have to include the international non-proprietary name (INN) of the medicine the test is used with. There were myriad reasons for the extension.