Value Added Medicines
Zydus inks a new 505(b)(2) oncology deal, taking over the commercialization of RK Pharma’s undisclosed sterile injectable in the US.
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
Teva is continuing to decide whether to speed up the FDA review time for its proposed long-acting olanzapine injectable, though the company has numerous options for deploying its priority review voucher across a busy late-stage pipeline.
Outlook Therapeutics believes its revised filing addresses the FDA’s sole remaining concern from an August complete response letter, setting up a potential mid-2026 decision on its wet AMD therapy.
Sandoz triumphed across four categories in the Global Generics & Biosimilars Awards 2025, with other winners including Accord, Adalvo, Amneal, Aurobindo, Cencora, Centrient, CNX Therapeutics, Hikma and Samsung Bioepis, as well as the AAM and its Biosimilars Council.
Glaukos’ FDA approval for Epioxa (riboflavin 5'-phosphate) under the 505(b)(2) pathway marks a major advance in keratoconus care, offering a less invasive, epithelium-on alternative that is set to launch in early 2026 with patient access programs.
As the FDA reviews its lead ADHD candidate, a dexmethylphenidate hybrid, Cingulate is pairing scale-up manufacturing with AI-driven marketing to smooth its transition into commercialization.
Xspray Pharma has welcomed an “important milestone” after the FDA agreed to review its proposed hybrid version of Tasigna (nilotinib), which the Swedish firm says has shown a markedly reduced food effect compared to the reference product.
Aspire Biopharma has its eye on key strategic goals in 2025 and 2026, including for its lead candidate, a sublingual high-dose aspirin product that it hopes to position as a first-line emergency treatment for suspected heart attacks.
Registration is open to attend the Global Generics & Biosimilars Awards 2025 in Frankfurt on October 29. Attendance is free, while options are also open to book a table for the night from which to enjoy our prizegiving ceremony.
FDA approval of a new indication for Teva’s risperidone long-acting injectable Uzedy expands its reach beyond schizophrenia, unlocking a major growth opportunity in the bipolar I disorder market.
Xspray Pharma has received a second FDA complete response letter for its 505(b)(2) dasatinib tablet, Dasynoc, after manufacturing observations at a contract facility delayed approval despite no issues with the drug’s data package.
Another regulatory blow has not stopped Outlook Therapeutics and its ophthalmic bevacizumab, yet.
The final shortlist of entries across all 14 categories of the Global Generics & Biosimilars Awards 2025 has now been revealed, ahead of our prizegiving ceremony in Frankfurt on 29 October.
MedRx has announced US FDA approval for its lidocaine patch, which has been a long time coming after multiple complete response letters over the past few years.
Teva has reported positive trial results for its latest in-development long-acting injectable, olanzapine – as well as offering further data on its Uzedy risperidone LAI compared to Invega Sustenna (paliperidone).
The nasal spray formulation of bumetanide was approved by the US FDA for edema associated with congestive heart failure and hepatic and renal disease.
With needed funds in its pocket, Serina is set to advance its apomorphine therapy, which was developed with a proprietary delivery technology.
Orexo believes its data further demonstrates the ability of the AmorphOX powder-based intranasal formulation technology to develop formulations for large molecules.
PharmaTher’s intravenous ketamine product Ketarx was just approved by the US FDA for surgical pain management. As it searches for commercial partners before the year ends, the firm now looks to enjoy the regulatory incentives and market exclusivity of orphan diseases.