Manufacturing

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

IntelGenx has once again been frustrated in its attempts to challenge Collegium’s powerful opioid Belbuca in the US, amid ongoing litigation over the brand’s three US patents that run until December 2032. Meanwhile, Teva’s desire to push on with its own January 2027 launch has been called into question.

Bora Pharmaceuticals has completed its takeover of Upsher-Smith from Sawai, with the acquisition opening up new US opportunities for the Taiwanese company including providing the firm with its first US manufacturing sites.

As Sandoz continues to fight against antimicrobial resistance, the firm opens a new production facility in Austria, strengthening its position in Europe with a vertically integrated production network for penicillin.

Alvotech stepped into its 2023 annual financing results call bursting with positive news and momentum, on the back of obtaining USFDA approval for its biosimilar Humira product and a bullish outlook for its strong pipeline of biosimilar candidates.

EuroAPI is on the backfoot once again after being forced to suspend production at its manufacturing site in Brindisi, Italy, weeks after unveiling a four-year strategic roadmap that sought to tighten and focus its operations amid a challenging two years.

Although the two Canadian off-patent industry bodies support new initiatives that expand drug coverage for Canadians, they remain cautious about the use of pricing schemes that could potentially affect drug supply of generics.

Ahead of a planned September UN meeting, the industry group and key companies demand concrete steps that could turn the tide in the fight against antimicrobial resistance.

Fresenius Kabi has completed the divestment of a manufacturing plant in Halden, Norway, to Prange Group.

Gedeon Richter is putting its hand back in its wallet following its recent investment in Formycon, opting to take control of a pair of joint ventures established with German firm Helm.

KVK Research and KVK Tech failed to notify the US FDA about the use of a foreign API manufacturing facility and submitted alleged false claims to governmental health programs.

Powered with robotic and artificial intelligence technologies, Mark Cuban’s Cost Plus Drug Company aims to manufacture drugs in shortage and bypass pharmacy benefit managers.

The company’s third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations.

Principal deputy director of the US FDA’s Center for Drug Evaluation and Research, Jacqueline Corrigan-Curay, used part of her 20-minute keynote address at the recent AAM Access! annual conference to focus on drug shortages that persist across the US.

The AAM’s annual Access! 2024 conference brought its much-enjoyed CEOs Unplugged panel to Tampa again for another engaging discussion on critical issues, challenges and opportunities for generics and biosimilars in the US.