Value Added Medicines
Teva is lining up Europe as the next regulatory market for its long-acting injectable olanzapine, following its US filing late last year, as the company looks to build a global schizophrenia franchise.
Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.
European CNS specialist rolls out a value-added methylphenidate and a first-to-market guanfacine generic as it sharpens its European ADHD strategy.
Management says it is prepared to sacrifice early volume if pricing fails to reflect the drug’s role in moderate to severe schizophrenia.
Viatris is entering the new year with several key achievements under its belt.
Outlook Therapeutics has once again been frustrated in its attempts to gain US FDA approval for an ophthalmic formulation of bevacizumab – and the latest complete response letter from the agency does not seem to offer a clear path ahead.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
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.