Drug Delivery
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
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When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
Bristol Myers Squibb’s $2.3 billion Houston manufacturing campus is part of the company’s larger $40 billion investment designed to bolster American innovation and manufacturing.
News of the joint venture comes months after AstraZeneca vowed to spend $15 billion in China by the end of the decade.
The shift from ex vivo to in vivo gene delivery is rewriting the rules of viral vector manufacturing, forcing developers to rethink scale, purity, cell lines and analytics as vectors themselves become the drug. AGC Biologics is betting on stable producer lines, next‑gen purification and deeper characterization to meet the far stricter demands of in vivo therapies.
The additional cuts, which will primarily occur between 2027 and 2029, will cost some $6 billion as the pharma tries to ride out a post-COVID headache while facing stiff patent headwinds for major products like the blood thinner Eliquis.
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.
The investment will expand Resilience’s U.S. capacity to make the KwikPen device Eli Lilly uses to deliver its injectable diabetes and obesity medicines.
ElevateBio will be the primary source of Kyverna’s autologous CAR T cell therapy for anticipated U.S. and global launches in autoimmune indications.
The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
Top-selling cell therapies from BMS, J&J and Gilead depend on a BioLife product, positioning Repligen to use the takeover to increase its exposure to the modality.