Legal & Regulatory

The list price of Casgevy for transfusion-dependent beta thalassemia has yet to be released, however, the cost for the treatment in sickle cell disease is $2.2 million.

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

Acquisition is expected to offer life sciences clients a boost in expertise and insight.

Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.

Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

Rinatabart sesutecan (Rina-S; PRO1184) showed encouraging antitumor activity and tolerability in patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Cretostimogene grenadenorepvec is a novel, intravesically delivered oncolytic immunotherapy under evaluation for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.

Aglatimagene besadenovec and prodrug plus chemoradiation prior to surgery was found to produce an extended and sustained survival benefit among patients with borderline resectable pancreatic ductal adenocarcinoma.

Popular works in the category explore 340B guidelines, ‘smart pharma’ capabilities, and commercialization trends.

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis.

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

The FDA previously granted the application for Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) with priority review and breakthrough designation for patients with locally advanced or metastatic urothelial cancer.

The FDA based the approval Merck’s Welireg (belzutifan) on findings from the randomized, open-label, Phase III LITESPARK-005 trial, which compared Welireg to Afinitor for the treatment of advanced RCC that has progressed after prior treatment with PD-1/L1 and VEGF-TKI therapies.

Eflornithine (Iwilfin) is indicated to lower the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who showed at least a partial response to previous multi-agent and multimodality treatment that included an anti-GD2 immunotherapy.

The seminar examines where members of the pharma supply chain stand in terms of preparation, being that the act has officially been enacted.

FDA approves bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy for the treatment of sickle cell disease, which affects approximately 100,000 people in the United States.

Novartis anticipates Fabhalta to be available in the United States in December for the treatment of paroxysmal nocturnal hemoglobinuria.

Johnson & Johnson’s TAR-200 has a novel targeted releasing system that allows for a controlled release of gemcitabine in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

Opdivo (nivolumab) plus cisplatin-based chemotherapy shows improved survival benefits in the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Jaypirca (pirtobrutinib) is indicated for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who received at least two prior lines of treatment with a Bruton tyrosine kinase inhibitor and a BCL2 inhibitor.

Ongoing clinical trials are evaluating zotatifin (eFT226) plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for the treatment of ER–positive, HER2-negative advanced or metastatic breast cancer.

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

In clinical trials, roflumilast cream demonstrated rapid and sustained improvement in the signs and symptoms of atopic dermatitis in patients 6 years of age and older.

In clinical trials, KarXT (xanomeline-trospium) demonstrated a combination of strong tolerability and clinically meaningful symptom reduction in adult patients with schizophrenia.

The approval of Ogsiveo represents an important therapeutic advance for patients with progressing desmoid tumors requiring systemic treatment.

AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly) for the treatment of adults with follicular lymphoma that is relapsed or refractory following treatment with two or more therapies.

Alladapt Immunotherapeutics said the FDA Fast Track designation highlights the importance of developing a treatment for multiple food allergens.

Webinar Date/Time: Thu, Dec 14, 2023 11:00 AM EST

The FDA also approved a companion diagnostic test to detect the PIK3CA, AKT1, and PTEN alterations as part of the approval for AstraZeneca’s capivasertib (Truqap) plus fulvestrant (Faslodex) for HR-positive, HER2-negative locally advanced or metastatic breast cancer.