Bluebird Bio Inc. has completed a rolling BLA filing of beta-thalassemia gene therapy beti-cel in the U.S., with analysts predicting that the Cambridge, Mass.-based biotech will have to shoot for a lower price tag after running into trouble with cost regulators in Europe.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aft, Aim, Ampio, Genmab, Hyloris, Mayne, Seagen, Verrica.
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
Little more than six months after filing a BLA for the antibody-drug conjugate (ADC) tisotumab vedotin in recurrent or metastatic cervical cancer, Seagen Inc. and Genmab A/S have secured an accelerated approval for the medicine. The green light for the co-developed product marks Seagen's third approved ADC and Genmab's first marketed therapy, though another medicine based on its Duobody technology platform recently won approval, too. The new cervical cancer drug, to be marketed as Tivdak, was approved for the treatment of adults experiencing disease progression on or after chemotherapy.
Enacting provisions to control U.S. prescription drug prices remains a top priority with many members of Congress as they push through the Biden administration’s budget agenda – despite warnings that government price controls on drugs would come at the cost of innovation.
Verrica Pharmaceuticals Inc.’s launch plans for drug-device candidate, VP-102 (cantharidin 0.7% topical solution), in the viral skin infection molluscum contagiosum were hit with another delay, as the FDA issued a complete response letter (CRL) in response to the NDA, just two days ahead of its Sept. 23 PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Biontech, Celltrion, Exelixis, Forge, Incyte, Luye, Marinus, Pfizer, Rhythm, Samsung.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Abcellera, Alvotech, Aveo, Beigene, Biogen, Biomea, Biontech, BMS, Deciphera, Galapagos, Henlius, Innocare, Janssen, Keymed, Merck, Moderna, Pfizer, Protagonist, Roche.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. Byooviz is the first ophthalmology biosimilar to win the go-ahead in the U.S., and was approved in the EU on Aug. 18, 2021, followed by the U.K. on Aug. 31, 2021.
Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 62% to $17.53 on Sept. 17 after it reported finding malignant skin tumors in a mouse model test of its most advanced candidate, rusfertide for blood disorders. After the company notified the FDA, the regulator put the program on a clinical hold, leading dosing of patients in all ongoing trials of rusfertide to be halted for now. The development could impact Protagonist's ability to start phase III testing of the candidate in polycythemia vera (PV) early in 2022, as well as efforts to expand its development to a third indication beyond PV and hereditary hemochromatosis (HH) by the end of this year, as it has planned.
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