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.
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?
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.
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.
Reformulation specialist Lipella has an eye on numerous milestones for its proposed oral rinse liposomal formulation of tacrolimus, including the submission of a Phase IIb clinical trial investigational new drug application.
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.
