ABBVIE

After a July surge in FDA approvals for gastroenterology, including the first blood test for colorectal cancer, the agency saw a summer lull with only three GI approvals. Notable approvals included Skyrizi for UC and Crohn’s, a rapid HCV test for point-of-care use, and a third ustekinumab biosimilar.

AbbVie receives positive CHMP opinion for mirvetuximab soravtansine (ELAHERE®) for treating FRα-positive, platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer in adults who have undergone 1-3 prior treatments.

Mantle cell lymphoma (MCL) treatment outcomes improve with novel targeted therapies like BTK inhibitors. DelveInsight's 'Mantle Cell Lymphoma Pipeline Insight 2024' covers 20+ companies developing 22+ therapies, including Venetoclax and ADI-001. Key events include AstraZeneca's Phase III ECHO trial and BeiGene's AACR presentation.

AbbVie, a pharmaceutical firm with strong immunology and oncology portfolios, is compared against key competitors in the Biotechnology industry. The analysis reveals AbbVie's high Price to Earnings (64.53), Price to Book (50.28), and Price to Sales (6.22) ratios, suggesting a potentially overvalued stock. However, its high Return on Equity (18.4%), EBITDA ($5.0B), and gross profit ($10.26B) indicate strong profitability and operational efficiency. The company's low revenue growth (4.31%) compared to the industry average (28.79%) raises concerns about future performance.

Trishula Therapeutics reports positive Phase I results for TTX-030, an anti-CD39 antibody for first-line metastatic pancreatic cancer, showing 30% objective response rate, 7.5 months median progression-free survival, and 19.1 months median overall survival. A global Phase II trial, ELTIVATE, is now enrolling.

A study reveals *ubrogepant* (brand name *Uberlevi*) may prevent migraines if taken at pre-migraine symptoms, with 65% reporting minimal pain 24 hours later. The drug targets CGRP protein, offering potential for proactive migraine management.

Biosimilars are FDA-approved biologic medications highly similar to reference products, offering competitive pricing and expanding patient access. Between 2015-2023, biosimilars provided nearly 700 million therapy days without unique clinical challenges. The US biosimilar approval process is expedited, focusing on similarity to reference products. Interchangeability designation allows biosimilars to be substituted without prescriber intervention. President Biden's FY 2025 budget proposes unifying biosimilar and interchangeable standards. As of July 2024, the FDA has approved 56 biosimilars, including 10 adalimumab biosimilars. Biosimilars contribute to cost savings and market competition, with projected market growth to $129 billion by 2027. Policy changes, like CMS's temporary payment increase for biosimilars, aim to enhance accessibility. Health care systems like Providence St. Joseph Health have successfully integrated biosimilars, achieving significant cost reductions.

The HIMALAYA study's 5-year survival analysis shows 19.6% survival with STRIDE (durvalumab plus tremelimumab) vs 9.4% with sorafenib in unresectable hepatocellular carcinoma, with no new safety concerns.

FDA granted accelerated approval to epcoritamab-bysp (Epkinly) for relapsed/refractory follicular lymphoma, based on EPCORE NHL-1 trial results. Dr. Jennifer Crombie discusses the approval's significance and future of FL treatment.

CDSCO revoked Entod Pharmaceuticals' authorization to market PresVu eye drops, citing false claims and safety concerns around pilocarpine, the active ingredient.