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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.

Industry stakeholders must come together to make meaningful changes to reimbursement and establish comprehensive policies that support essential healthcare providers.

Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

As the use of emerging technologies such as generative artificial intelligence continues to grow to support the innovation goals of Fortune 500 companies, so too does the risk of cybersecurity breaches.

In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.

Scemblix (asciminib) plus investigators’ choice of tyrosine kinase inhibitor showed clinically meaningful and statistically significant data in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.

Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising.

Merck is actively enrolling patients across Phase III trials for four novel candidates for hematologic malignancies and solid tumors.

Tina Fresta, BA, MPH is the Strategic Solutions Senior Manager at epocrates, keeps a close eye on the pharmaceutical and bio science industry shifts, leveraging those insights to inform both our partners and our company of the most strategic approach to reach business goals.

Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies.

The LillyDirect platform will allow patients who are prescribed the popular weight loss drug Zepbound to obtain the drug via Lilly’s at-home prescription delivery service.

Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

JAMA study investigates whether physical or behavioral healthcare needs are associated with the risk of underinsurance across household income levels.

Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound.