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ANI Pharmaceuticals has completed its acquisition of niche generics specialist Novitium Pharma, securing access to a pipeline of generics and 505(b)(2) candidates that has expanded further since the deal was announced earlier in the year.
The US FDA has set a PDUFA date for Hyloris’ Maxigesic IV 505(b)(2) NDA that is earlier than expected, following two positive Phase III trials, spurring hopes that the product could also see earlier commercialization and registration than previously anticipated.
Celltrion has taken home three awards while Sandoz and Dr Reddy’s have walked away with two prizes each, after winners were announced at the Global Generics & Biosimilars Awards 2021, held in Milan, Italy, on 10 November.
A new European initiative will offer scientific advice, fee waivers and other support to not-for-profit and academic sponsors to help them find new uses for existing medicines and hook up with commercial companies to seek marketing authorization.
Just one week remains to book free tickets to the Global Generics & Biosimilars Awards 2021, which is taking place on 10 November at the Stella Polare, Fiera Milano in Milan, Italy.
In November, ANI Pharmaceuticals is hoping to complete a major acquisition, Viatris may shed further light on the state of the US generics industry and Generics Bulletin will host its eighth annual Global Generics & Biosimilars Awards, this year once again in person.
Adamis has announced receiving FDA approval for Zimhi, its high-dose naloxone hydrochloride for injection, indicated for the treatment of opioid overdose. The company has partnered with US WorldMeds to market Zimhi by the first quarter of 2022.
Value-added medicines specialist Hyloris has announced launch plans for its Maxigesic IV analgesic in the UK and Ireland after receiving approvals for the intravenous paracetamol/ibuprofen solution. The nods follow two deals aimed at bolstering the firm’s pipeline.
Glenmark is celebrating the approval of its Ryaltris nasal spray in 13 European countries, with the Indian company and partner Menarini set to begin rolling out the allergic rhinitis combination product.
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