Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Value-Added Medicines

Set Alert for Value-Added Medicines

ANI Pharmaceuticals Completes $210m Novitium Acquisition

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.

Deals M & A

Hyloris Gets Head Start On Maxigesic IV In US

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.

Value-Added Medicines United States

Celltrion Takes Trio Of GGB Awards In Milan

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.

Generic Drugs Biosimilars

EU Drug Repurposing Pilot Kicks Off

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.

Europe Value-Added Medicines

One Week To Go Until GGB Awards

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.

Generic Drugs Biosimilars

What’s Next? Five Things To Look Out For In November

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.

Generic Drugs Biosimilars

Adamis Receives FDA Approval For 505(b)(2) Naloxone

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. 

United States Approvals

Hyloris Prepares For UK And Ireland Maxigesic IV Launch

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.

Approvals Deals

Glenmark Celebrates European Ryaltris Approvals

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.

Value-Added Medicines Approvals
See All
UsernamePublicRestriction

Register