Strategy

Only days after its initial announcement, Hypera Pharma has refused EMS’ proposed merger on grounds of undervaluation and different strategic priorities.

Generics Bulletin previews the most noteworthy and anticipated events for November 2024.

Strides is to supply semaglutide and liraglutide to generics companies amid global capacity constraints and drug shortages, ahead of loss of exclusivity. An ability to make drug-device combinations has meant it has contracts for seven of the eight GLP-1 agonists, and counting.

In the wake of its recent acquisition of dermatology assets from Canute Pharma, UK-based Aspire Pharma is looking to new frontiers of expansion in Europe and beyond. Chief executive Richard Condon talks to Generics Bulletin about the next steps on the niche generics and value added medicines firm’s journey.

Celltrion gave updates on several business aspects and reassured its shareholders that the delayed insurance listing for Zymfentra will not affect its set annual sales goal.

Backed by AI and former FDA official Janet Woodcock, Every Cure is set to identify approved drugs for patients who don’t have treatment options around the world.

Zentiva has launched a bid to take control of German “single pill company” Apontis Pharma, with a €10-per-share offer that values the enterprise at €85m. If successful, Zentiva plans to establish the firm as a standalone branded division.

Delegates from European institutions and industry representatives unpacked the many challenges of improved access to critical medicines on the continent in a session at this year’s European Health Forum.

Days after Gilead’s signing of voluntary licensing with six generic manufacturers for its HIV drug Sunleca, ViiV announced its commitment to ramping up Apretude’s supply to countries in need.

Teva has broken new ground by filing its first independent biosimilar to the US Food and Drug Administration, for a proposed biosimilar to Amgen’s Prolia treatment for osteoporosis in postmenopausal women. However, the Israeli firm made no mention of its proposed Xgeva biosimilar, which it states is in Phase III clinical trials.

Neuraxpharm is making further waves outside of Europe, launching operations in the Middle East just a year after entering Central and South America.

Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.

Aspire Pharma has bolstered its dermatology portfolio by striking a deal to acquire “all assets” of another UK-based player, Canute Pharma.

Teva is continuing along its well-trodden path of partnered biosimilar assets, striking a further agreement with Spanish develop mAbxience that could be for the development of either pembrolizumab or nivolumab.

Aeon Biopharma has heralded its latest interaction with the US FDA over its planned Botox biosimilar as a win that sets the stage for analytical studies, trials and a subsequent filing.

Teva has begun shipping the first US generic version of Novartis’ Sandostatin LAR Depot – a synthetic polypeptide that is part of a difficult-to-manufacture class of long-acting polymers.

Teva’s CEO Richard Francis has spoken candidly about the steps he has taken in order for Teva to reclaim its credibility, underpinned by the company’s ‘Pivot to Growth’ strategy.

Organon and Henlius have marked progress on their partnered HLX11 pertuzumab candidate, with the proposed biosimilar to Perjeta meeting the primary endpoint in a Phase III trial.

Xbrane says scientific advice from the US FDA on a “streamlined” clinical program for its proposed nivolumab biosimilar, comprising just a single trial, will cut the development costs and timeline for the Opdivo rival, making it more attractive as Xbrane seeks a commercialization partner.

In a closely anticipated US Senate Committee hearing, Novo’s CEO was grilled by US senator Bernie Sanders and others on the high price of Ozempic and Wegovy in the country.