News

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.

Electronic health record messaging network found to improve communication and lead to better medication adherence.

Provider’s Pithampur facility is recognized for its use of Industry 4.0 technology.

Study examines the parallels between doctorate students and the US population.

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.

The latest move expands the company’s storage capacity and cold chain capabilities.

Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers.

Teams need to keep close track of ingredients, processing parameters, and material performance so that they can use their R&D data to decide exactly which materials to make next.

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

Over the past year, Pharma Commerce’s digital coverage featured a variety of subject matters, ranging from how to calculate 340B prices, to the future of pharmacy.

The most popular pieces pertaining to the supply chain featured ADMs, vaccine supply chains, and wholesalers.

Items in this sector ranged touched on topics such as pharma shipping, container technology, and sustainability.

This year’s PC Podcast episodes ranged in topic, from DSCSA compliance to pharmacovigilance.

A panel designs a conceptual framework in an effort to limit partiality.

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure.

If the FDA approves garadacimab, it would be the first approved hereditary angioedema therapy that targets activated FXIIa.

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

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

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.

Moderna previously filed marketing authorization submissions for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 years and older.

Jemperli has shown potential both as a monotherapy and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.

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

Cloud-based service to address verification of saleable returns under the latest DSCSA regulations.

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.

Breakout session summarizes key areas that will affect all aspects of the industry.

Creating a meaningful digital transformation requires pharmaceutical manufacturing companies to incorporate the right technologies, processes, and systems to reach their fullest potential.

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 conference hosts a diversity, equity, and inclusion (DE&I) Summit featuring personal insights and experiences.

Pfizer said that the addition of Seagen to its current operations could add more than $10 billion in risk-adjusted revenues by 2030.