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PharmaShots Weekly Snapshots (April 10 - 14, 2023)

PharmaShots

Ocugen Reports Preliminary Results from the P-I/II Trial of OCU400 for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis Date: Apr 14, 2023 | Tags: Ocugen, OCU400, Retinitis Pigmentosa, Leber Congenital Amaurosis, Clinical Trial, P-I/II Trial Candesant Biomedical Receives the US FDA Clearance of Brella SweatControl Patch for Primary (..)

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PharmaShots Weekly Snapshots (May 01 - 05, 2023)

PharmaShots

Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EC’s Marketing Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease Date: May 05, 2023 | Tags: Chiesi Global Rare Diseases, Protalix BioTherapeutics, PRX-102, pegunigalsidase alfa, Fabry Disease, Regulatory, EC, Marketing Authorization Kinoxis Therapeutics (..)

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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

It joins a number of other BCMA-directed therapies for multiple myeloma, including GSK’s first-to-market antibody-drug conjugate Blenrep (belantamab mafodotin), Bristol-Myers Squibb/bluebird bio’s CAR-T therapy Abecma (idecabtagene vicleucel) and J&J/Legend Biotech’s CAR-T Carvykti (ciltacabtagene autoleucel).

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After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

pharmaphorum

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. CellCentric, a U.K-based

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Cartherics grants licence for CTH-004 to Shunxi

Pharmaceutical Technology

Australian biotechnology company Cartherics has granted licence for CTH-004 , its autologous CAR-T cell product, to Chinese company Shunxi. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

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Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. Bruce Levine [BL]: We now have six approved CAR-T therapies. How has the field changed in recent years?

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CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) – an antibody directed at CD38 – and BCMA-targeted CAR-T therapy Carvykti (ciltacabtagene autoleucel).

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