United States

Cambrex is accelerating API capacity expansion across the US and Europe, advancing a $120m Iowa project and a $30m Milan upgrade as it builds scale in complex chemistries, peptides and high-potency manufacturing amid rising reshoring demand.

Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.

“Four or five major acquisitions over the last few years repositioned it, a 140-year-old company, from being a B-to-B company to B-to B-to-C company. That is a major enterprise strategy shift,” says CEO Patrick Lockwood-Taylor.

“In a very siloed organization made up of a jigsaw of different companies, no one was thinking enterprise first,” says Perrigo CEO Patrick Lockwood-Taylor. “The fundamentals of running operations, brand-building, innovation, they are now as they were.”

After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.

Chugai’s partnering office in South San Francisco advances the Japanese company’s business development activities in the US beyond its venture fund established in Boston in 2023.

Agency offered to drop annual IND fees for sponsors not conducting Phase I trials in US, but industry still raised several concerns about fee incentives for onshoring clinical development.

At opening session of CHPA’s annual Self-Care Leadership Summit on March 17 in Orlando, it presented Fuad Sawaya its highest honor named for Ivan Combe, an industry pioneer who served on its board from 1958 until 2000.

Alvotech is shifting toward dual-source manufacturing and operational execution as it addresses FDA setbacks, expands its biosimilar pipeline and drives growth through global launches, with US approvals representing key upside to its 2026 outlook.

A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.

Celltrion has added a subcutaneous formulation to its Avtozma biosimilar in the US, completing a dual-presentation strategy aimed at matching Actemra and improving uptake in a market where biosimilar penetration has so far remained limited.

NRx says the FDA has identified no bioequivalence deficiencies in its Ketafree ANDA, clearing a key hurdle ahead of a potential mid-2026 decision as the firm pursues parallel generic and innovative ketamine strategies.