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BioPharmaceutical

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.

Lupin Looks To Expand In China With Respiratory Alliance

Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.

Outlook Launches Ophthalmic Bevacizumab In Germany And The UK

Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Replacements Named As Eder Leaves Stada And Medicines For Europe

Stephan Eder has left Stada and stepped down as president of Medicines for Europe, with the company announcing plans for his replacement and the association naming Polpharma CEO Markus Sieger as the association’s new interim president.

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.

Hyloris Secures US Approval For Avenacy-Partnered RTU Tranexamic Acid

After signing a deal with Avenacy at the end of last year, Hyloris has now announced the approval of its intravenous formulation of tranexamic acid, which is used as a hemostatic agent.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Generic Drug Office’s Policy Staff Returning To US FDA

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.

Formycon Snatches Brazilian Approval For Lucentis Biosimilar

Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.