Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Baxter, RDIF, Regeneron, Roche, Sensorion, Spero.
CDC director Rochelle Walensky’s early morning announcement on Sept. 24 recommending boosters for certain frontline workers was considered wise by some but as undermining her advisers and the process by others. She endorsed the Advisory Committee on Immunization Practices’ recommendation for booster doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine but overruled one of the panel’s Sept. 23 decisions by adding boosters for people ages 18 to 64 who are at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks.
Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaccine, Algernon, Arcturus, Bluebird, Carisma, Cytodyn, Incyte, Inovio, Inventiva, Moberg, Pharmamar, Radius Health, Rhythm, Taysha Gene Therapies, Tryp.
Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country.
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.
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