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Strategy

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Zydus Looks To Revlimid Opportunity, Pivots To Multivariant COVID-19 Vaccine

Zydus is looking to launch a Revlimid generic in the second wave while an opportunity might soon emerge from Takeda’s Pentasa. It is also pivoting to a multivariant version of its plasmid DNA vaccine against COVID-19, ZyCoV-D, after the original didn’t receive an encouraging response.

Strategy Sales & Earnings

Centrient Hails Milestone For Clean Antibiotic Production

Centrient has celebrated passing a “significant milestone in the clean production of antibiotics” after meeting Predicted No Effect Concentration discharge targets set by the AMR Industry Alliance across its entire oral antibiotics product range.

Manufacturing Supply Chain

Amneal Makes It Three With Pegfilgrastim Approval

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Biosimilars Approvals

Olon Invests In R&D Hub In Italy

Italy’s Olon has announced a €10m investment in a new R&D hub in Rodano, Milan, that the active pharmaceutical ingredient specialist says will help to consolidate its expertise and connect its worldwide network of 11 facilities.

Research & Development Manufacturing

Prestige Management Fights Back Following Biosimilar Rejection

Prestige BioPharma’s top brass are looking to restore shareholder confidence following the surprise failure of their trastuzumab biosimilar before the EMA’s CHMP.

Biosimilars Strategy

Nichi-Iko Aims To Regroup As It Enters Turnaround Process

Japan’s Nichi-Iko has formally entered a business turnaround alternative dispute resolution process that will see the company outline a business rehabilitation plan involving management restructuring and a fresh profit structure, following financial underperformance in the wake of recent quality issues.

Strategy Sales & Earnings

Civica Rx COO McCoy To Step Into CEO Role From 1 June

Civica Rx’s chief operating officer Ned McCoy is to step up as CEO, ahead of the company’s landmark manufacturing facility commencing operations in early 2024.

Executive Changes Leadership

Alvotech’s Ustekinumab Passes Safety And Efficacy Milestone

Alvotech has announced success in its confirmatory clinical safety and efficacy study for its AVT04 ustekinumab candidate, a proposed biosimilar to Stelara.

Biosimilars Clinical Trials

Hikma Searches For New CEO As Olafsson Resigns

Hikma is looking for a new CEO after announcing that chief executive Siggi Olafsson will be leaving the company “to pursue other opportunities” on 24 June. In the meantime, executive chairman and former CEO Said Darwazah will take on his leadership responsibilities.

Executive Changes Leadership
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