Pharmaceutical Commerce Editorial Staff

LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.

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.

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

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.

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.

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.

MoU aims to align the pharmaceutical and cold chain sectors by boosting operations.

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.

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

MAPS Public Benefit Corporation was previously granted Breakthrough Therapy Designation by the FDA for MDMA and is seeking a priority review for the NDA submission of the psychedelic treatment for post-traumatic stress disorder.

AstraZeneca's deal to acquire Icosavax is expected to bolster AstraZeneca’s Vaccines & Immune Therapies late-stage pipeline with IVX-A12, a potential first-in-class vaccine for both respiratory syncytial virus and human metapneumovirus.

Bristol Myers Squibb strikes deal with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate that has shown promise in non-small cell lung cancer and breast cancer.

Phase III INTerpath-002 trial will evaluate the novel individualized neoantigen therapy V940 (mRNA-4157) with Keytruda (pembrolizumab) as an adjuvant treatment for patients with non-small cell lung cancer.

Adults and children aged 1 year and older are eligible for the IV formulation of Cresemba for invasive aspergillosis and invasive mucormycotic, whereas the prescribed capsule is only indicated for adults and children 6 years of age and older.

The rise in demand represents the third consecutive month of year-on-year growth.

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.

An independent Data Monitoring Committee found that Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not produce an improved overall survival benefit vs. Keytruda in combination with chemotherapy followed by Keytruda plus a placebo in patients with metastatic squamous non-small cell lung cancer.

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

Eli Lilly and Company's obesity drug Zepbound (tirzepatide) has a list price of $1,059.87, which is approximately 20% less than the 2.4 mg semaglutide injection indicated for weight loss.