All News

In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses changes that will come with the pharma giant's new platform.

Bloomlife’s MFM-Pro is a prescription-based wearable device that can track the maternal and fetal heart rate.

HyQvia is the only subcutaneous immune globulin infusion that can be administered once per month.

Researchers believe low numbers in the use of direct-to-consumer healthcare services could rapidly trend up.

Vertex Pharmaceuticals' and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease.

Generative artificial intelligence, key new product launches, and the evolution of the go-to-market model are among key trends to watch in the year ahead.

Company displayed findings at the 2024 Winter Clinical Dermatology Conference in Hawaii demonstrating significant improvements in atopic dermatitis and seborrheic dermatitis.

New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.

Soaring healthcare costs show little sign of slowing in 2024, with concerns growing about the affordability of medications and medical services.

Dupixent is an IL-4 receptor alpha antagonist that has been approved for the treatment of adults with moderate-to-severe atopic dermatitis, as well as asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.

Roots Analysis report suggests increase can be attributed to the growing demand for advanced therapies and biologics.

Each program strengthens the pharma value chain, impacting the core areas of clinical development, supply chain, and manufacturing and commercial engagement.

The FDA issued the 39th overall approval for Keytruda (pembrolizumab), with the latest in combination with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

Ginkgo Bioworks announces projected total revenue of $250–$260 million for 2023 for large scale data generation and artificial intelligence for biopharma R&D.

Although medications such as Mounjaro and Zepbound have shown efficacy in helping individuals lose weight, there are not yet enough results to fully support these claims.

RC88 is under evaluation for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.

The BioThrax vaccine is indicated for active immunization to prevent anthrax disease caused by Bacillus anthracis in individuals aged 18 through 65 years.

Axon Therapy uses magnetic peripheral nerve stimulation to deliver a non-invasive treatment for chronic pain related to nerve damage caused by diabetes.

If the FDA approves the abbreviated new drug application for Lutetium Lu 177 Dotatate, the drug will be eligible for 180 days of generic marketing exclusivity in the United States for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors.

Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the best evidence for defense.

SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia.

SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation.

Moderna’s vaccine revenue dropped from $18.4 billion in 2022 to $6.7 billion in 2023, however the company anticipates profitability this year powered by COVID-19 vaccine sales and the launch of its mRNA-based respiratory syncytial virus vaccine.

Lutikizumab (ABT-981) will advance to a Phase III trial in patients with moderate to severe hidradenitis suppurativa who previously failed anti-tumor necrosis factor therapy.

A commentary by former FDA Commissioner Scott Gottlieb, MD, addresses uncertainty regarding how the FDA will regulate new technologies, such as artificial intelligence.

Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies.

The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.