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What’s Next? Five Things To Look Out For In June
Generics Bulletin previews the most notable and anticipated events for June 2023.
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.
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.
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New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific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.
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.
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.
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.
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.
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.
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