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On 26 March 2024, MSD announced that its WINREVAIR™ (sotatercept-csrk) has been approved by the FDA for treating adults with pulmonary arterial hypertension (PAH).  FDA classified WINREVAIR™ as a breakthrough therapy due to it representing a new class of therapy which funct...

The perils of prioritising commercial strategies over patenting strategies
Pearce IP’s Founder Naomi Pearce discusses this topic on prime time radio with ABC Law Report Host Damian Carrick, in light of the recent decision of the Federal Court in Allied Pumps Pty...

The Korea Biomedical Review reports that South Korean company, Sam Chun Dang Pharm Co Ltd (SCD), has entered an exclusive distribution agreement with an unnamed distributor to supply its Eylea® (aflibercept) biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, ...

On 25 Mar 2024, Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for (up to) € 1.025B comprised of an initial payment and milestone payments.
Cardior Pharmaceuticals specialises in RNA-targeted therapies aimed at preventing, repairing, and reversing h...

On 24 March 2024, the Korea Economic Daily (KED) reported Samsung Bioepis entered pre-clinical stage, with multiple undisclosed gene therapy candidates, for the treatment of rare diseases.
According to KED, Samsung Bioepis is committed to advancing drug development th...

On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of two Janssen patents regarding the use of ustekinumab for the treatment of ulcerative...

On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults.
Once-weekly Awiqli® d...

On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting.  CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars:

Sandoz’s denosumab bio...

On 22 March 2024, Korea Biomedical Review reported Geo-Young, South Korea’s largest pharmaceutical distributor,  signing a third-party logistics (3PL) contract with Samsung Bioepis for the distribution of biosimilar medicines within South Korea. This is the first busi...