Dr Reddy’s Laboratories announced completion of a successful phase I clinical trial of DRL_TC, its biosimilar to Genentech’s Actemra® (tocilizumab) by intravenous route. The study demonstrated the pharmacokinetic equivalence, safety, and immunogenicity of DRL_TC compared t...
Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar. The partnership allows Rani to use Celltrion’s adalimu...
Samsung Biologics revealed in a regulatory filing with Korea Exchange that it has signed a US$81M CMO contract with a ‘European pharmaceutical company’. The contract amount is 3.58% of sales and is binding on the two companies. Samsung said that when the main contract is ...
MSD announced positive results in two studies evaluating Keytruda®, its anti-PD-1 therapy.
MSD reported that its Phase 3 KEYNOTE-671 trial evaluating Keytruda® plus chemotherapy before surgery and continued as a single agent after surgery showed reduced risk of dis...
Jackson J in Austin Engineering Pty Ltd v Podulova & Ors [2023] FCA 419 issued interlocutory Norwich Pharmacal orders against ex-employee Anastasis Podulova and her new employer...
Innovent announced that it has entered into a clinical trial collaboration and supply agreement with Merck KgGA for a combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX®). Innovent says the therapy is a potential treatment for non-small cell lung cancer (NSCLC)...
Pearce IP, an award-winning Australian boutique Intellectual Property firm, specialising in the pharma, biopharma and life sciences industries, has joined Australia’s peak body for ...
Novartis announced that the European Commission (EC) has approved its Cosentyx® (secukinumab) for a new indication to treat active moderate to severe hidradenitis suppurativa (HS) in adult patients who have had an inadequate response to conventional systemic HS therapy. Th...
Coherus announced it is launching YUSIMRY® (adalimumab-aqvh) biosimilar to AbbVie’s Humira®, in July 2023 with a list price of $995 per carton. This is the lowest price announced of any adalimumab product in the US, and represents an 85% discount on the originator product....
Celltrion has received marketing authorization from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). It has been approved for the full range of indications previously approved for Remic...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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