Strategy

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.

As it announced the start of trials for its AVT16 proposed rival to Takeda’s Entyvio, Alvotech reiterated that it is one of just two publicly-disclosed biosimilar developers targeting vedolizumab.

The potential of the UK’s life sciences sector continues to be critically misunderstood and should be the cornerstone of both society and the economy, according to Teva’s CEO Richard Francis.

After being sued by Alimera earlier this month, ANI has now completed its acquisition of the company, boosting its commercialized drug portfolio with two original products.

Ipca is considering merging its US generic formulations businesses Bayshore Pharmaceuticals and Unichem Pharmaceuticals USA into a single entity, according to newly-unveiled plans that will be considered by directors in a week’s time.

Local regulatory intelligence, internal milestones, core dossier, and digital tools – all key ingredients for streamlined regulatory submissions in emerging markets, experts say.

Sandoz’s partnership with Polpharma to bring a US biosimilar to Tysabri to the US would make it “ultimately the closest I will ever get to an originator launch in my career,” according to Sandoz CEO Richard Saynor. However, the launch has hit a roadblock in the form of a necessary assay approval for a virus that can trigger a potentially life-threatening brain disease.

Philip Morris described a scenario of being essentially blacklisted by the healthcare sector and its CDMO partners, as the tobacco manufacturer threw in the towel on its £1.1bn acquisition of UK-based inhalation specialist Vectura by agreeing to offload the firm at a fraction of the initial cost.