Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Generics

Set Alert for Generics

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

Generics Bulletin previews the most notable and anticipated events for June 2023.

Biosimilars Generic Drugs

Glucagon And Epinephrine Continue To Drive Growth At Amphastar

Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.

Sales & Earnings Generic Drugs

UAE’s Bioventure Is Looking For Partners To Expand

Having recently added to its biosimilars alliance with Alvotech, Dubai-based Bioventure says it is looking to expand its international reach through further partnerships.

Strategy Deals

Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Generic Drugs Clinical Trials

Medicines For Europe Highlights Industry Agenda

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

Europe Legislation

Yaral To Expand Burgeoning Generics Portfolio With Support From Eversana

With three additional commercial launches lined up for 2023, Yaral has opted to expand its pre-existing partnership with life sciences service provider Eversana to support these activities. 

Generic Drugs United States

Pharmascience Welcomes Canadian Ruling On Nitrosamines

Pharmascience was among the firms that were named in a class action lawsuit in Canada over the presence of nitrosamine NDMA in ranitidine. Now, the company has welcomed a summary judgement decision by the Supreme Court of British Columbia to dismiss the claims.

Generic Drugs Legal Issues

ANI Aims For CGT Top Spot With Two New Launches

ANI Pharmaceuticals has heralded the approval and launch of two new US competitive generic therapies as giving it a joint leadership position in the CGT space.

Approvals Launches

FDA Issues 46 Fresh Product-Specific Guidances

The latest batch of product-specific guidance documents to aid generic development has been published by the US FDA, with the 46 new and revised PSGs covering products including an ophthalmic implant, nasal sprays and powders for inhalation.

Guidance Documents Generic Drugs
See All
UsernamePublicRestriction

Register