Biologics
Senators Mike Lee (R-UT), Ben Ray Luján (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) have introduced the Biosimilar Red Tape Elimination Act to increase competition within the biosimilar drug market and increase access to low-cost drugs. The legislation would deem approved biosimilars as
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FDA has published a draft guidance, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products, to give sponsors of INDs and applicants of BLAs for cellular and gene therapy (CGT) products recommendations about product comparability and the management of manufacturing changes for investigational and licensed CGT products. The
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FDA has accepted for review a Dr. Reddy’s Laboratories BLA for its proposed biosimilar rituximab (Genentech’s Rituxan) candidate, indicated for treating adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. Dr. Reddy’s says its submission
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FDA has issued Warning Letters to two medical firms for violations involving human cells, tissues, and cellular and tissue-based products (HCT/Ps). A 6/27 Warning Letter went to New Hope Center for Reproductive Medicine in Virginia Beach, VA, following a 12/8/22-1/23/23 agency inspection
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Three Goodwin attorneys analyzed Warning Letters issued following Bioresearch Monitoring (BIMO) program inspections in 2022. Their online post says that BIMO conducted 504 inspections of clinical investigators in FY 2022. Of the 504, nine resulted in a classification of “official action indicated” and 87 resulted in a classification of “voluntary
Biologics
Takeda says it has withdrawn a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on “aspects of data collection, which cannot be addressed within the current BLA review cycle.” The vaccine’s future plan in the U.S. will be further evaluated, it says, adding
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Sarepta Therapeutics has sold for $102 million its Rare Pediatric Disease Priority Review Voucher that was awarded last month after gaining accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl) for treating ambulatory pediatric patients aged four through five years with Duchenne muscular dystrophy. The company did not disclose the buyer of
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FDA has issued Alvotech a complete response letter (CRL) for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVie’s Humira (adalimumab). The letter cites manufacturing deficiencies that were documented during a 3/17 reinspection of the company’s Reykjavik, Iceland facility, according to the company. “The CRL
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CBER has issued an updated calendar year 2023 guidance agenda. The updated document lists the guidances the Center currently intends to develop in three categories: Blood and Blood Components (6 guidances). Therapeutic Products (6 guidances), and Other (1 guidance).
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FDA has issued a complete response letter (CRL) on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye drug for treating patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. The submission is being held up “solely due to an
Biologics
FDA has approved a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. The company describes the subcutaneous infusion as a IgG4 monoclonal antibody that binds to the neonatal Fc receptor,
Biologics
UCB says FDA’s review of its BLA resubmission for bimekizumab for treating adults with moderate to severe plaque psoriasis has been extended for undisclosed reasons. UCB previously said it expected FDA action in the second quarter and now it expects this in the third quarter. In 5/2022, FDA
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CBER director Peter Marks overrode his Center’s review team in granting the 6/22 accelerated approval of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys, a move reminiscent of a review override (see story) almost seven years ago by then-CDER director Janet Woodcock on a Sarepta NDA
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FDA has granted Sarepta Therapeutics accelerated approval for its BLA for Elevidys, the first gene therapy to treat pediatric patients aged four through five years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing
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FDA has accepted for priority review a bluebird bio BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for patients with sickle cell disease ages 12 years and older who have a history of vaso-occlusive events. The agency has set a user fee review action target date of 12/
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FDA has granted full approval to Amgen’s previously accelerated-approved BLA for Blincyto (blinatumomab) for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
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FDA has granted Genentech accelerated approval for its BLA for Columvi (glofitamab-gxbm) and its use in treating adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of
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One day after an FDA advisory committee voted 21 to 0 (see story) to recommend that the Covid-19 vaccination program for the 2023-2024 season should contain a monovalent vaccine comprising the XBB-lineage variant, the agency posted a notice that adhered to the panel recommendation. The 6/16
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FDA’s Vaccines and Related Biological Products Advisory Committee 6/15 voted 21 to 0 that the Covid-19 vaccination program for the 2023-2024 season should contain a monovalent vaccine comprising the XBB-lineage variant. Panel members essentially agreed with an FDA briefing document released in advance of the
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Public Citizen’s Health Research Group is urging FDA to not grant accelerated approval to Sarepta Therapeutics’ gene therapy SRP-9001 for treating ambulatory Duchenne muscular dystrophy (DMD) because the data do not justify approval. In a 6/15 letter to the agency, the advocacy group says the data failed
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FDA reviewers are recommending that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant, which is currently the predominant strain in the U.S. In a just-posted briefing document released in advance of a 6/15 Vaccines and Related
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FDA has approved a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin (nadofaragene firadenovec-vncg) and the company’s plan to scale-up its drug substance manufacturing process at FinVector Oy located in Kuopio, Finland. The company says supplies from the scale-up process manufactured at FinVector’s facility