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John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.

Approval marks the first generic version of liraglutide injection, referencing Victoza, for improving glycemic control in adults and children aged 10 years and older with type 2 diabetes, alongside diet and exercise.

Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a notable placebo-adjusted triglyceride reduction at 12 months.

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.

These professionals in the healthcare marketing sector have been chosen by their peers for making big moves and taking on larger roles.

Amid the end of a national GLP-1 shortage, the FDA will now require all compounding, distributing, or dispensing of compounded tirzepatide injections to end within 90 days.

Collaboration aims to enhance PSMA-B ligand, a novel theranostic molecule in development for the treatment of prostate cancer.

Sermo’s survey also reveals some troubling aspects about the public’s relationship with these medications.

The molecule is an investigational pre-clinical oral GLP-1 receptor agonist.

Breakthrough Therapy designation for Trodelvy was granted based on promising results from the Phase II TROPiCS-03 study, which showed encouraging antitumor activity in both platinum-resistant and platinum-sensitive extensive-stage small cell lung cancer.

Approval of Steqeyma was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis.

New biologics license applications seek FDA approval for Merck’s clesrovimab to protect infants and children from respiratory syncytial virus and Johnson & Johnson’s Simponi for the treatment of ulcerative colitis.

Approval of Vtama for atopic dermatitis provides a steroid-free treatment option for adults and pediatric patients.

This will bring Nimble’s psoriasis and inflammatory bowel disease treatment under AbbVie’s pipeline.

The Breakthrough Therapy Designation for Jemperli was based on Phase II clinical trial data, showing a 100% clinical complete response rate in patients with locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.

Approval of Unloxcyt was based on results from the CK-301-101 trial, which showed the drug is the first FDA-approved PD-L1–blocking antibody to produce clinically meaningful and durable objective response rates in patients with metastatic or locally advanced cutaneous squamous cell carcinoma.

Berger joins Gilead with over 25 years of global drug development experience and will oversee the company’s virology, oncology, and inflammation portfolio.

The regulatory action was supported by results from the Phase III HERCULES trial, which demonstrated a 31% reduction in six-month confirmed disability progression in non-relapsing secondary progressive multiple sclerosis.

Eli Lilly and Boehringer Ingelheim are also participating in the campaign, which will feature a float in the 2024 Rose Parade.

The two organizations are promoting education and the importance of screenings.

This acquisition will bring Aliada’s Alzheimer’s treatment under AbbVie’s pipeline.

Because the AI space is changing rapidly, it’s essential that companies are budgeting correctly and using their investments strategically.

The report details the experiences of Hispanic, Black, and Asian patients.

Both firms were heavily focused on pharma and healthcare marketing during the previous year.

For pharma manufacturers, the primary requirement for working with high-profile clients is matching their organizational level of urgency and organization.

The actress is participating in the campaign for its third year.

The videos are designed to help bring people together during the holidays.

Real-world evidence from the largest analysis of second-line treatment with Yescarta in 2022-2023 demonstrated a high overall survival rate in patients with relapsed/refractory large b-cell lymphoma.

Breakthrough designation was based on results from the TROPION-Lung05 Phase II trial with support from the TROPION-Lung01 Phase III trial of datopotamab deruxtecan in patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

Ziihera’s addition as a category 2A treatment follows the FDA’s accelerated approval of the drug for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer.