R&D/Clinical Trials

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

Indication of Adbry (tralokinumab-ldrm) expanded to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable.

Pivotal trial findings show favorable clinical safety and efficacy data for mRNA-1345 in lowering the incidence of respiratory syncytial virus-associated lower respiratory tract disease.

Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer.

Zoryve (roflumilast) topical foam, 0.3% is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades.

In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer.

Erasca will initiate the pivotal SEACRAFT-2 trial in the first half of 2024 to evaluate naporafenib in combination with trametinib in adults with unresectable or metastatic melanoma with an NRAS mutation.

Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck's Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy.

Welireg (belzutifan) approved for the treatment of adults with advanced renal cell carcinoma that progressed after a regimen of a PD-1 or PD-L1 inhibitor and a VEGF-TKI.

Eflornithine (Iwilfin) approved by FDA for 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.

MAPS Public Benefit Corporation filed a new drug application for MDMA (midomafetamine capsules) for use with psychological intervention for the treatment of post-traumatic stress disorder.

Current industry challenges present an opportunity for innovation and the adoption of new solutions, particularly in addressing barriers related to patient recruitment, engagement, and retention.

Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer.

Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.

Lack of trust in pharma-provided content proves to be a key barrier to successful engagement, highlighting issues like promotional spin, information availability, and more.

Cresemba is now the only azole antifungal treatment approved by the FDA for use in pediatric patients as young as 1 year of age with invasive aspergillosis and invasive mucormycotic.

FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease.

PREPVACC study expected to stop further HIV vaccination attempts after previously enrolling 1,500 participants in East and Southern Africa.

Migraine with comorbid obesity have been found to cause high levels of disability and are both more common in female patients.

Trial of Keytruda (pembrolizumab) plus chemotherapy and maintenance Lynparza (olaparib; AstraZeneca, MSD) for the treatment of metastatic squamous non-small cell lung cancer stopped after data did not show a survival benefit.

Fabhalta (iptacopan) is the first oral monotherapy approved by the FDA for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Jaypirca (pirtobrutinib) granted accelerated approval by the FDA for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered least two prior lines of therapy that included a BTK inhibitor and a BCL2 inhibitor.

The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.