The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
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Zymfentra is a subcutaneous version of infliximab.
Voxzogo is now approved for all ages in children with achondroplasia, the most common form of dwarfism.
Patients taking Mounjaro after a lifestyle intervention saw a weight reduction of almost 20%.
The increase is close to inflation and wage growth but much steeper than the atypically small increase in 2022.
Researchers in this review suggest clinical trials of biosimilars include switching studies to assess the pharmacokinetics of the biosimilar candidate.
Whether Opill (norgestrel) truly broadens access to daily contraception will depend on Medicaid coverage, requirements under the ACA and pharmacist prescribing.
Velsipity is the second oral S1P receptor modulator approved by the FDA to treat patients with moderate-to-severe ulcerative colitis. The wholesale acquisition cost is $6,164 for a 30-day supply.
Researchers identified age and insurance type as significant factors in viral suppression in patient with HIV because of their impact on patient adherence.
The regulatory agency found deficiencies in its inspection of Alvotech’s Reykjavik, Iceland, facility. The company plans to resubmit its application once these are addressed.
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The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.
Yuflyma is on Ventegra’s public and private formulary on parity with the reference product Humira.
Insurers and PBMs now have to follow a 2020 rule in which accumulator programs can only be applied to brand name drugs that have generic equivalents available.
Inpefa is an inhibitor of both SGLT2 and SGLT1, approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The wholesale acquisition cost is $598 per month.
The IV formulation has a wholesale acquisition cost of $2,115 per vial and will be available in the fourth quarter.
Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
The dosage of Zoryve for children 6 to 11 is the same as for those over the age of 12. The list price is same for both pediatrics and adults — $825 per tube.
Patients who continued with their rheumatoid arthritis biologic medication tended to spend less on healthcare, had a lower chance of being hospitalized, and had shorter hospital stays.
Issues related to finding from an FDA inspection at a third-party filler have been resolved.
Mark Campbell, Pharm.D., RxBenefits’ senior vice president of clinical solutions, talks about how Medicare’s drug price negotiations could have a ripple effect on pharmaceutical company innovation and prices on the commercial side.
Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.
Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.
ICER has weighed in on two of the 10 drugs selected for negotiations: Eliquis and Xarelto, which are among Medicare Part D’s highest spending drugs.
Once Medicare’s negotiated price for prescription drugs goes into effect, payers have more of an incentive to steer patients to lower-cost alternatives.
In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.
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