ANI Pharmaceuticals has recorded its highest-ever quarterly revenue of $73.9m during Q2, following the launch of its cortrophin gel and a substantial growth in generics revenue.

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

An average price rise of over 1,400% was seen for alendronate 70mg tablets in the UK last month, as average prices for a host of other generics more than doubled.

Following a challenging first half for Hikma, executive chairman and CEO Said Darwazah talks to Generics Bulletin about how the firm is planning to be more active in making deals happen, as well as how it plans to address pressures on its Generics division that led to two consecutive downgrades in guidance this year.

Despite a couple of setbacks during Q2, Amneal has sustained continual growth across its business, particularly in the injectables space.

Following a trio of complete response letters received since late 2018, Mayne Pharma and partner Mithra Pharmaceuticals have finally obtained US FDA approval for a generic version of Organon’s NuvaRing vaginal hormonal contraceptive ring.

Hikma has once again downgraded its expectations for its generics business in 2022 as it revealed a first-half drop of 18% in sales for the unit. However, injectables and branded increases helped to offset the decline, while the company maintained that generics growth was on the horizon in 2023.

A batch of four dozen new and revised product-specific guidances for generic products has been published by the US Food and Drug Administration, spanning a range of routes, dosages, and therapeutic areas.

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.