Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
Generics Bulletin reviews global regulatory developments across the globe.
Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.
IGBA secretary general Susana Almeida takes Generics Bulletin through an almost two-decade journey of developing global regulatory convergence and the next goals for the off-patent industry.
Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
The EU’s Critical Medicines Act is finally here. But did the European Commission’s decision to fast-track the legislation result in it falling short?
Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.
Amneal has spoken excitedly about its Crexont (carbidopa/levodopa) extended-release capsules as the Parkinson’s disease drug passes six months on the market.
Following steady updates on its development of a new formulation of valacyclovir, Hyloris revealed the US FDA’s acceptance of its NDA filing while also announcing three new deals this month.
The Global Generics & Biosimilars Awards is taking place in Frankfurt this October, with the event returning to Germany in its twelfth year for an even bigger and better awards ceremony that will recognize the most outstanding achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.
In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.
Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.
Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.
Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.
