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Recent BioBlast® Updates

Celltrion Rebrands Canadian Biosimilar Infliximab to Remdantry™

Mar 11, 2025

On 11 March 2025, Celltrion announced that its biosimilar infliximab for injection, currently known as Inflectra®, will be rebranded to Remdantry™ in Canada commencing on 1 April 2025…

Coherus Exits Biosimilar Business with Pegfilgrastim Sale to Accord BioPharma

Mar 10, 2025

On 10 March 2025, Coherus BioSciences reported its fourth quarter and full year financial results for 2024, and announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma…

Sun Pharma to Acquire Checkpoint Therapeutics

Mar 9, 2025

On 9 March 2025, Sun Pharma and Checkpoint Therapeutics announced that they have entered into an agreement for Sun Pharma to acquire Checkpoint Therapeutics. Under the deal, Sun Pharma will…

Biocon Announces Positive Ph 3 Results for Biosimilar Ustekinumab

Mar 7, 2025

On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic…

Approval Alert: FDA Approves Celltrion’s Omlyclo® as First Interchangeable Omalizumab Biosimilar

Mar 7, 2025

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is approved as a …

New Indication Alert: BMS’ Opdivo®/Yervoy® Combo EU-Approved for First Line Treatment of Unresectable/Advanced HCC

Mar 7, 2025

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with …

New Indication Alert: AstraZeneca’s Durvalumab Approved in India for Limited-Stage Small Cell Lung Cancer

Mar 7, 2025

On 7 March 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved its Imfinzi® (durvalumab) 120 mg/2.4 mL and 500 mg/10 mL solution for infusion…

Amgen and Fresenius Kabi Settle US BPCIA Denosumab Litigation

Mar 7, 2025

On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi…

Approval Alert: Sun Pharma Achieves First Generic Liraglutide Approval in Australia

Mar 6, 2025

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia. The product was approved by Australia’s Therapeutic Goods…

Eisai/Biogen’s Leqembi® Receives Further Reimbursement Consideration by UK’s NICE for Early Alzheimer’s Disease

Mar 6, 2025

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in …

MSD and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

Mar 5, 2025

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered MSD an opportunity to licence patents owned by Halozyme…

MSD and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

Mar 5, 2025

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered Merck (known as MSD outside the US and Canada) an opportunity to licence patents owned by Halozyme …

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Recent BioBlast® Updates

Celltrion Rebrands Canadian Biosimilar Infliximab to Remdantry™

Coherus Exits Biosimilar Business with Pegfilgrastim Sale to Accord BioPharma

Sun Pharma to Acquire Checkpoint Therapeutics

Biocon Announces Positive Ph 3 Results for Biosimilar Ustekinumab

Approval Alert: FDA Approves Celltrion’s Omlyclo® as First Interchangeable Omalizumab Biosimilar

New Indication Alert: BMS’ Opdivo®/Yervoy® Combo EU-Approved for First Line Treatment of Unresectable/Advanced HCC

New Indication Alert: AstraZeneca’s Durvalumab Approved in India for Limited-Stage Small Cell Lung Cancer

Amgen and Fresenius Kabi Settle US BPCIA Denosumab Litigation

Approval Alert: Sun Pharma Achieves First Generic Liraglutide Approval in Australia

Eisai/Biogen’s Leqembi® Receives Further Reimbursement Consideration by UK’s NICE for Early Alzheimer’s Disease

MSD and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

MSD and Halozyme in US Patent Dispute as Subcutaneous Pembrolizumab Launch Approaches

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