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Drug Delivery News

Drug Delivery News

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Roche pours $750M into Oregon manufacturing plant as obesity push expands

After committing $2 billion to a new North Carolina facility to boost capacity for its next-gen obesity candidates, Roche's Genentech is putting down more cash to expand a device fill-finish site in Oregon.

Scribe’s early-stage IPO standout defies biotech’s derisking trend

Scribe Therapeutics’ one-time epigenetic treatment is designed to slash the adherence burden of chronic cholesterol-lowering therapies while sidestepping the irreversibility of gene editing.

Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars

The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.

FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues

ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns.

Scholar Rock rejigs approval filing after FDA flags violations at Novo plant

Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.

BMS picks Texas for new $2.3B manufacturing campus

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.

AstraZeneca partners with CSPC to build Chinese biologics manufacturing plant

News of the joint venture comes months after AstraZeneca vowed to spend $15 billion in China by the end of the decade.

From ex vivo to in vivo: Shaping the next generation of viral vector manufacturing

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.

Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity

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.

Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor

Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.