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CD19 CAR-T agents to boost blood cancer market

European Pharmaceutical Review

Breyanzi sales will also be supplemented by the anticipated approval in chronic lymphocytic leukemia (CLL) in 2027, making it the first and only currently marketed CD19 CAR-T agent to penetrate the CLL market.

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RWE There Yet? FDA’s New Pilot Program Seeks to Help Usher in a New Era for Real World Evidence

The FDA Law Blog

The Federal Register notice states that the Advancing RWE Program “seeks to identify approaches for generating RWE that meet the regulatory requirements in support of labeling for effectiveness ( e.g. , new indications, populations, dosing information) or for meeting post-approval study requirements.”

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AbbVie files Qulipta for chronic migraine prevention

pharmaphorum

Expansion of Qulipta’s label to include patients at the more severe end of the spectrum would give Qulipta a niche on its own without competition from Nurtec ODT, which is also approved to treat acute migraine attacks in competition to Qulipta stablemate Ubrelvy (ubrogepant).

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

Broad label questioned. billion in 2027. ICER argues that Aduhelm was effectively approved on the strength of a biomarker – removing amyloid from the brain – rather than clinical outcomes, which is “puzzling” as other drugs have been shown to remove amyloid from the brain yet failed to help patients.

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Endometriosis market projected to grow at a CAGR of 10% between 2020 and 2030

Pharmaceutical Technology

This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively. GlobalData’s report also covers a third pipeline candidate, quinagolide, a dopamine receptor antagonist being developed by Ferring Pharmaceuticals.

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AbbVie sees bigger role for Qulipta in migraine prevention

pharmaphorum

AbbVie said it will file the PROGRESS data with regulators to try to extend the label for Qulipta to include people with chronic migraine, giving it an edge over Nurtec ODT in the prevention category. billion by 2027.

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Proposed LDT Rule Raises Many Questions but Provides Few Answers

The FDA Law Blog

Labs must also begin complying with device labeling requirements (21 C.F.R. Stage 2 (two years after issuance of the final rule) : Register with FDA as a device establishment and list LDTs performed, pursuant to 21 C.F.R. Part 801) and investigational device exemption requirements (21 C.F.R.

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