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BioBlast w/e 16 Dec 22: Doer Biologics and Merck collaboration, expanded Dupixent® indications, Fresenius US citrate-free Idacio® (adalimumab) approval, Merck and Moderna cancer vaccine trial results, Amgen acquires Horizon, Alvotech lists on Nasdaq Iceland Main Market, Regeneron seeks expedited motion in aflibercept dispute

by | Dec 19, 2022

Significant biosimilar activities this week include:

15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials

Zhejiang Doer Biologics announced a clinical trial collaboration agreement with Merck to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab).  Under the agreement, Doer Bio will conduct the clinical study in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.

15 Dec 22 | EU | Dupixent® (dupilumab) also approved for prurigo nodularis

Regeneron and Sanofi announced that the EC has expanded  the marketing authorisation for Dupixent® (dupilumab) in the EU to include adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.  Dupixent is the only taregeted medicine to treat prurigo nodularis approved in Europe and the US.

14 Dec 22 | US | FDA approves Fresenius’ citrate-free biosimilar adalimumab Idacio®

Fresenius Kabi announced that the FDA has approved its citrate-free biosimilar adalimumab (Idacio®) for all Humira® indications.  Idacio was approved in the EU 2019.  Fresenius intends to launch in the US in July 2023 pursuant to its settlement agreement with AbbVie.

13 Dec 22 | Merck and Moderna announce success in mRNA-4157/V940/Keytruda® trial

Merck and Moderna announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940 (investigational personalized mRNA cancer vaccine), in combination with Keytruda® (pembrolizumab), demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus Keytruda alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection.  Merck announced in October 2022 that it had exercised its option to jointly develop and commercialise mRNA-4157/V940.

12 Dec 22 | Amgen to acquire Horizon Therapeutics

Amgen announced that it will acquire Horizon Therapeutics for $27.8 billion.  Amgen reported that it expects the acquisition to strengthen its innovative therapeutic portfolio, adding a number of rare disease drugs to its portfolio, including Uplizna® (inebilizumab-cdon), Tepezza® (teprotumumab-trbw) and Krystexxa® (pegloticase)

08 Dec 22 | Alvotech shares start trading on Nasdaq Iceland Main Market

Alvotech announced that its shares started trading on the Nasdaq Iceland Main Market in addition to the NASDAQ and NASDAQ first growth market, concluding its listing trilogy.  Alvotech announced that Nasdaq Iceland had approved its request for the admission of its shares on the Nasdaq Iceland Main Market under the ticket symbol ‘ALVO’ in early December 2022. Alvotech became the first dual US-Icelandic listed company on 23 June 2022.

06 Dec 22 | US | Regeneron seeks expedited motion in aflibercept dispute

In its aflibercept suit against Mylan in the Northern District of West Virginia Regeneron filed an expedited motion seeking to compel Mylan  to  redesignate its biosimilar regulatory file and regulator correspondence from “Outside Counsel’s Eyes Only” (“OCEO”) to enable Regeneron’s in-house Counsel to access the materials.    Regeneron has asked the court to de-designate Mylan’s aBLA immediately to confidential, and to correct the remainder of its designations.  Regeneron asserts that its in-house Counsel has already seen a substantial portion of the materials in the patent dance.

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